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AVENOVA.COM | 1 -8 0 0-8 9 0 -0 32 9
Daily lid and lash hygiene.
2AVENOVA NEWS | LETTER FROM RON NAJAFI, PH.D., CHAIRMAN & CEO OF NOVABAY PHARMACEUTICALS
Letter from Ron Najafi, Ph.D., Chairman
& CEO of NovaBay Pharmaceuticals
Dear Friend,
Welcome to the first edition of Avenova News,
a booklet of reprinted articles about our
revolutionary eye care product.
We at NovaBay believe that Avenova is
a breakthrough in eye care. It is the first
prescription, non-detergent, non-antibiotic
antimicrobial eye care product on the market.
It is proving to be remarkably safe and an
important component of the regimen for
the successful management of blepharitis,
meibomian gland dysfunction and associated
dry eye syndrome.
But please don’t just take my word for it. A
number of prominent ophthalmologists and
optometrists have been writing articles that
explain what’s unique about Avenova and
how it works to improve the quality of care for
countless patients. In addition, the eye care
trade press has been covering the introduction
of Avenova and the evidence of its benefits.
It is also worth mentioning that Avenova
contains Neutrox™, the purest Hypochlorous
acid commercially available today, with no
bleach impurities.
We will be producing more editions of Avenova
News on a regular basis as more educational
news material is published. In the meantime,
please enjoy reading what others have been
writing about our product.
	 Ron Najafi, Ph.D.
	 Chairman & CEO
	 NovaBay Pharmaceuticals, Inc.
3AVENOVA NEWS | CONTENTS
Contents
2
4
5
7
8
11
13
14
16
Letter from Ron Najafi, Ph.D., Chairman & CEO
of NovaBay Pharmaceuticals
Wash Away Your Old Hygiene Strategy
Christine W. Sindt, OD | Review of Cornea & Contact Lenses (RCCL)
Hypochlorous Acid Lid Cleanser Provides Novel Advantages
Featuring Kathryn Najafi, MD and Steven Lichtenstein, MD | Ophthalmology Times
New Avenova Effectively Treats Common Eye Problems in Elderly,
Says Phoenix Optometrist
Dr. Arthur B. Epstein | Phoenix Eye Care
Rx Lid Cleanser Aids Blepharitis, MGD
Optometry Times
New Blepharitis Treatments
Alan G. Kabat, OD, and Joseph W. Sowka, OD | Review of Optometry
New Eye Treatment Is “One of the Best Tools I’ve Found,”
Patient Reports
Kathryn Najafi, MD | Eye Institute
Alternative Products Available to Combat Ocular Surface Disease
Featuring Katherine Mastrota, MS, OD, FAAO | Primary Care Optometry News
New Study Shows Effectiveness of Avenova
VMail Technology
*The name of “i-Lid Cleanser” has been changed to “Avenova” in the above articles
to reflect the rebranding that occurred in January 2015.
4AVENOVA NEWS | WASH AWAY YOUR OLD HYGIENE STRATEGY
Wash Away Your Old Hygiene Strategy
By Christine W. Sindt, OD | 5/15/2014 | Review of Cornea and Contact Lenses (RCCL)
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
REFERENCES
1. McCann LC, et al. Tear and meibomian gland function in blepharitis and normals. Eye Contact Lens. 2009 Jul;35(4):203-8.
2. Panaser A, Tighe BJ. Evidence of lipid degradation during overnight contact lens wear: gas chromatography mass spectrometry as the diagnostic tool. IOVS. March 2014;d55(3):1798.
3. Craig JP, et al. The TFOS international workshop on contact lens discomfort: report of the contact lens interactions with the tear film subcommittee. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS71-97.
4. Willcox MD, et al. Potential sources of bacteria that are isolated from contact lenses during wear. Optom Vis Sci. 1997 Dec; 74(12):1030-8.
5. Stapleton F, et al. Changes to the ocular biota with time in extended- and daily-wear disposable contact lens use. Infect Immun. 1995 Nov; 63(11):4501-5.
6. Welling JD, et al. Chronic eyelid dermatitis secondary to cocamidopropyl betaine allergy in a patient using baby shampoo eyelid scrubs. JAMA Ophthalmol. 2014 Mar 1;132(3):357-9.
Early impressions of a
new eyelid cleansing
option to help keep your
patients’ eyes clean and
microbe-free
It really is no secret that clean eyelids
promote healthy contact lens wear.
As we’ve all seen clinically, patients
who have blepharitis exhibit significant
differences in tear physiology than
those without blepharitis.1
Tear lipids
are oxidatively stable in their native
environment because meibomian
glands predominantly secrete only
saturated and monounsaturated lipids.2
Stable lipids don’t degrade and don’t
cause discomfort or blur.
Blepharitis and meibomian gland
dysfunction (MGD) patients typically
experience heavy deposits of lipids
on their lenses. This phenomenon is
not limited to these patients, however.
These lipid deposits may also be seen in
those with no apparent MGD due to the
individual composition of the meibum.
Over time, lipids associated with the
contact lens will become unstable
and degrade. Once formed, these
deposits impair optical quality and the
wettability of the lens surface (with the
latter resulting in a quick break-up of
the tear film), which can eventually lead
to intolerance to contact lens wear.3
In addition to affecting the tear film,
vision and comfort, the lids play host
to myriad microorganisms. Bacterial
contamination of soft lenses is
associated with microbial keratitis
and corneal inflammatory events.
Normal ocular organisms include
coagulase-negative Staphylococci,
Corynebacterium species, Micrococcus
species, Bacillus species and
Propionibacterium species.4
The lid margin, commonly colonized by
microbes, is found to harbor organisms
up to 70% of the time.5 Additionally,
substantial lid bioburden is associated
with a 2.5-fold greater risk of substantial
lens bioburden, and is likely the major
route of lens contamination.5
A New Option
Keeping the lids clean, which in turn
keeps the lens clean, directly benefits
patient comfort, safety and quality of
vision. The “old-school” lid hygiene
method included the use of diluted
baby shampoo to remove debris
and contaminants. While it remains
convenient and inexpensive, this is not
as safe or simple as it may sound.
Baby shampoos—as well as some eyelid
cleansers—contain cocamidopropyl
betaine, a surfactant and lathering agent
that may cause an eyelid dermatitis.6
Surfactants, the key ingredient in most
lid scrub products, are also known to
dry the skin and strip the area of oil—
ironically, inducing increased production
of oil in the glands.
A novel product, Avenova* (NovaBay
Pharma­ceuticals), which contains
pure hypochlorous acid 0.01%, offers
practitioners a new option for lid
hygiene. Hypochlorous acid is a
naturally occurring chemical released
by neutrophils to kill microorganisms
and neutralize toxins released
from pathogens and inflammatory
mediators. As it is neutralized quickly,
it’s nontoxic to the ocular surface.
Other hypochlorous acid products
(e.g., Dakin) contain impurities (such as
bleach), which are toxic to the ocular
surface. In my experience, Avenova
offers excellent lid cleansing capability
without extraneous ingredients such
as surfactants.
Pure hypochlorous acid 0.01% has
shown to be fast acting against the five
major bacterial pathogens associated
with blepharitis during in-vitro laboratory
tests. Although some conventional lid
scrubs may lack antimicrobial activity
even after prolonged exposure, efficacy
of pure hypochlorous acid 0.01%
was documented after just seconds
of exposure, according to NovaBay
Pharmaceuticals. In direct comparisons,
the company says, pure hypochlorous
acid 0.01% demonstrated a similar
antibacterial spectrum of activity to
Betadine—with 1,000 times less toxicity.
Its antibacterial properties make
Avenova a welcome addition to any
blepharitis or MGD-related dry eye
treatment regimen. Additionally, the
product can be useful in make-up
removal and as an adjunct to contact
lens wear.
5AVENOVA NEWS | HYPOCHLOROUS ACID LID CLEANSER PROVIDES NOVEL ADVANTAGES
6/1/2014 | From Ophthalmology Times
New product associated
with excellent results,
high patient acceptance in
management of blepharitis
A novel eye-care product containing a
stabilized form of pure hypochlorous
acid (0.01%) in saline (Advanced
Avenova*, NovaBay) offers a safe
and effective alternative for cleansing
the lids, lashes, and periocular skin
of debris and microorganisms, which
can cause irritation, inflammation, and
ocular surface disease.
Hypochlorous acid is a bactericidal
component of the innate immune system.
Incorporation into a commercial product
required engineering a formulation that
would maintain the stability of the acid
and avoid other impurities.
Results from laboratory studies
evaluating the stabilized hypochlorous
acid show it has fast-acting,
broad-spectrum activity against
microorganisms found in the external
ocular flora, including methicillin-
resistant Staphylococcus aureus, plus
the ability to disrupt biofilm that harbors
bacteria. Laboratory testing has also
established that the product is non-toxic
to human tissues and non-irritating.
Merits of hypochlorous
acid cleanser
Kathryn Najafi-Tagol, MD,
founder, Eye Institute
of Marin, San Rafael,
CA, has been involved
in research evaluating
the properties of
hypochlorous acid.
In clinical practice, she has found
that when used in the management
of blepharitis, the lid cleanser is
associated with excellent results
and high patient acceptance.
“Blepharitis is a common problem
seen by eye-care practitioners.
It can have cosmetic, structural,
and functional sequelae, and the
availability of different options for
use by affected patients is desirable,”
Dr. Najafi-Tagol said. “Based on
its unique characteristics, the
hypochlorous acid cleanser is a
welcome addition to our toolbox.
“In my experience, it is extremely
helpful, and I appreciate that unlike
topical antibiotics and steroids, it can
be used safely on a regular, ongoing
basis,” she said. “Furthermore, the
hypochlorous acid cleanser is a simple
and elegant formulation with reduced
potential to cause skin irritation
compared with other commercial
lid cleansers containing buffering
ingredients, surfactants, and
preservatives. My patients have
been very pleased with the product,
enjoying not only its efficacy as a
cleanser but also what many describe
as a refreshing feeling.”
Managing blepharitis
Steven J. Lichtenstein,
MD, associate
professor of clinical
surgery and pediatrics,
University of Illinois
College of Medicine
at Peoria and Chicago,
and medical director of pediatric
ophthalmology, Children’s Hospital
of Illinois, Peoria, said he first began
recommending the hypochlorous
acid cleanser for use by patients
with blepharitis at the beginning of
2014, and the results achieved have
been excellent.
Dr. Lichtenstein noted that his
standard treatment for children with
chronic blepharitis has been dilute
baby shampoo lid scrubs combined
with a topical antibiotic and a steroid
as needed to control significant
inflammation. With this regimen,
however, he was always concerned
about the development of bacterial
resistance and steroid-related
complications, especially considering
the likelihood that parents might be
initiating repeat treatment on their
own using medication leftover from
a previous prescription.
Continued on next page.
BEFORE AFTER
Hypochlorous Acid Lid Cleanser
Provides Novel Advantages
6AVENOVA NEWS | HYPOCHLOROUS ACID LID CLEANSER PROVIDES NOVEL ADVANTAGES
Hypochlorous Acid Lid Cleanser
Provides Novel Advantages
“The hypochlorous acid cleanser is
not any harder or any easier to use
than the dilute baby shampoo, but it
seems to provide better results while
eliminating or reducing the need for
antibiotics and steroids along with their
associated costs and concerns,”
he said.
The cleanser is packaged in a spray
top bottle and should be dispensed
onto a cotton pad or cotton-tipped
applicator that is then used to scrub
along the lashes, lids, and as needed,
the periocular skin.
Dr. Najafi-Tagol noted that she only
suggests a cotton-tipped applicator
when she is confident the patient will
be able to use it safely and confirms
her impression by asking patients to
demonstrate their technique before
they leave the office.
Both Dr. Najafi-Tagol and Dr.
Lichtenstein said they have used
the lid cleanser for the management
of patients with both anterior and
posterior blepharitis.
In patients with meibomian gland
dysfunction (MGD), the lid cleanser
is combined with other lid hygiene
methods, such as warm compresses
directed at relieving gland obstruction,
Dr. Najafi-Tagol said.
“Using the lid cleanser to reduce the
bacterial burden on the eyelids is
useful in patients with MGD because
the organisms produce exotoxins
and lipases that can lead to the
development of evaporative dry eye
disease through their inflammatory
properties and effects on the
meibomian gland secretions,”
she explained.
Dr. Lichtenstein said he recommends
twice-daily use of the lid cleanser, in
the morning and at bedtime. So far, it
has been consistently effective, with
resolution occurring in some patients
within 2 weeks.
“I have not yet seen any child whose
blepharitis has recurred after the
successful use of this regimen
incorporating the lid cleanser,” he said.
“However, because of the safety of
this product, I am comfortable telling
parents that they can re-initiate its
use if they notice returning signs of
redness or debris.”
Steven J. Lichtenstein, MD
eyedoc44@aol.com
Dr. Lichtenstein has no relevant financial interest
to disclose.
Kathryn Najafi-Tagol, MD
kn@najafimd.com
Dr. Najafi-Tagol is also a member of NovaBay’s
Ophthalmic Advisory Board and serves as
medical monitor for NovaBay’s conjunctivitis
clinical trials.
6/1/2014 | From Ophthalmology Times
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
7AVENOVA NEWS | NEW AVENOVA EFFECTIVELY TREATS COMMON EYE PROBLEMS IN ELDERLY, ...
New Avenova Effectively Treats
Common Eye Problems in Elderly,
Says Phoenix Optometrist
By Dr. Arthur B. Epstein | 6/11/2014 | Phoenix Eye Care
In a recent webinar,
Dr. Arthur B. Epstein
of Phoenix Eye Care
explains how Avenova
can alleviate the suffering
from blepharitis and other
common eye conditions,
such as dry eye syndrome,
in the elderly
Dr. Arthur Epstein, Director of the Dry
Eye - Ocular Surface Disease Center
and Director of Clinical Research at
Phoenix Eye Care, announced in a
recent webinar that the elderly now
have a potent new solution for eye
problems such as inflammation of the
eyelids associated with blepharitis
and dry eye syndrome. These eye
conditions are especially common in
Arizona because of the large number
of retirees and the desert climate, said
Dr. Epstein.
The new treatment is Avenova*. It was
discovered and developed by Kathryn
Najafi-Tagol, MD, Founder and Medical
Director of the Eye Institute of Marin in
Marin County, California and scientists
from NovaBay Pharmaceuticals
(NYSE MKT: NBY) in Emeryville, Calif.
Avenova is preserved by a stable form
of hypochlorous acid, a substance
naturally made by the body’s immune
system as a first defense against
microbial invaders. Lab tests show that
Avenova not only kills bacteria, it also
neutralizes the toxins produced by
bacteria and is also completely safe to
skin around the eye. The Food & Drug
Administration has cleared Avenova
for the removal of foreign material,
including microorganisms, from skin.
“Those properties made Avenova an
ideal treatment for eye conditions,”
Dr. Epstein explained. “Blepharitis is
the most common and most visible
problem that eye care professionals
encounter,” he said. “We see a
tremendous amount in our practice
in Phoenix.”
Blepharitis is typically caused by Staph
bacteria that grow on eyelids, causing
swelling, redness, inflammation,
irritation and a crusty build-up. “It can
be very irritating,” Dr. Epstein said. “The
Avenova safely removes the bacteria
and the crusty material, providing
significant relief.”
Doctors have been using Avenova
regularly at Phoenix Eye Care and
at the Eye Institute of Marin to treat
blepharitis, as this video and this
product backgrounder explain.
“Two-thirds of the patients I see are
coming in for dry eye therapy,” said Dr.
Epstein. Dry eye is typically a result of
meibomian gland disease, where the
growth of Staph bacteria cause the
meibomian glands to be obstructed
by thick waxy secretions, causing dry
eye. The Avenova removes both the
bacteria and the bacterial toxins from
eye lids and lashes. “It has tremendous
utility for this condition,” said Dr. Epstein.
“Overall, control of lid flora is one of
the most important things we can do
as physicians,” said Dr. Epstein. Now,
Avenova makes that possible.
Phoenix Eye Care, PLLC and the Dry Eye
Center of Arizona, PLLC combine the skills and
experience of two highly respected optometrists,
a caring staff and state-of-the-art instrumentation
and diagnostic equipment. Phoenix Eye Care
provides a full range of primary eye care services
including comprehensive eye examinations,
LASIK evaluations, pre-and post-operative
management, contact lenses, diabetic eye
examinations and much more.
Contact: Dr. Arthur B. Epstein Phoenix Eye Care
Phone: (602) 549-2020 Fax: (602) 325-5536
Email: phxeyecare@gmail.com
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
SOURCE: Phoenix Eye Care
8
9/29/2014 | Optometry Times
Contact lens wearers also
see benefit
Everything from our high-tech
lifestyles1
outdoor environmental
factors, and the general aging of the
population can lead to blepharitis, dry
eye disease (DED) and meibomian
gland dysfunction (MGD). Sustained
tasks, such as reading, can reduce the
blink rate to as low as five blinks per
minute.2
This slow blink rate can cause
additional stress on an ocular surface
that is already compromised due to
one of the aforementioned disorders.
It is not surprising that the limited
prevalence data currently available
suggest ocular disorders, such as dry
eye, are increasing in prevalence.3
Patients experience discomfort as
well as reductions in both productivity
and overall quality of life. Blepharitis,
for example, tends to be a chronic
condition, and no one treatment has
proven curative thus far.4
Some of
the treatments used for these ocular
diseases have included: lid scrubs,
mild shampoos, warm compresses, and
antibiotic ointments. The FDA recently
cleared the novel Rx eyelid cleanser
(NovaBay Pharmaceuticals, Inc.), which
is designed to enhance lid hygiene and
help to alleviate these conditions.
Assess dry eye from a
systemic standpoint
DED, MGD, and blepharitis
DED is typically the result of
insufficiency of tear quality or volume,
which leads to inadequate lubrication
of the ocular surface.5
A variety of
signs and symptoms are associated
with DED, including: grittiness, burning,
irritation, foreign body sensation,
redness, fluctuating vision, and
increased blink rate.6,7
The link
between the signs and symptoms of
DED has proven inconclusive to date.8
MGD is one of the leading causes
of DED throughout the world.9
The
Tear Film and Ocular Surface Society
(TFOS) described MGD as “a chronic,
diffuse abnormality of the meibomian
glands, commonly characterized
by terminal duct obstruction and/or
qualitative/quantitative changes in the
glandular secretion.”9
Blepharitis is one of the most common
eye disorders,10,11
but the condition
often goes undiagnosed due to the
fact that it can sometimes be perceived
by the patient as being a nuisance
rather than a legitimate medical
concern. Blepharitis is an inflammatory
disease of the lid margin with a
multifactorial etiology.10
This condition
encompasses pathologic conditions of
the pilosebaceous unit of the anterior
lid or the meibomian gland of the
posterior lid.12
The anterior form is
usually caused by bacterial overgrowth
and/or sebaceous gland activity, while
the posterior form is caused by MGD,
the most common causative factor
for evaporative dry eye. Blepharitis
is typically diagnosed using several
hallmark signs and symptoms including:12
•	 Heavy/puffy eyelids
•	 Itching/burning eyelids
•	 Dry, irritated eyes
•	 Crusting or flaking of the lids
	 on awakening
Currently, there is a paucity
of prevalence data regarding
blepharitis.10,11
This is due, in part,
to the fact that the disease often
exists as a comorbid condition
with DED, seborrheic dermatitis,
atopy, acne rosacea, etc.,12
which
makes a differential diagnosis
more challenging. To address this
knowledge gap and increase our
understanding of blepharitis, Lemp
and Nichols conducted a survey of
5,000 individuals in the U.S. and found
that 79.3 percent had experienced
at least one symptom related to
blepharitis during the previous 12
months.12
Furthermore, 32 percent of
respondents experienced at least one
symptom half of the time.
Lemp and Nichols also surveyed 120
ophthalmologists and 84 optometrists
to evaluate the frequency of ocular
surface symptoms associated with
blepharitis.12
About 47 percent of
optometry patients and 37 percent of
ophthalmology patients were suffering
from these symptoms. Most ODs (97
percent) agreed or strongly agreed
that DED is a common comorbidity with
blepharitis/MGD. Most (94 percent) of
ODs agreed or strongly agreed
Continued on next page.
BEFORE AND AFTER: These images show a patient’s lid both before and after
usage of Avenova. Note the difference in lashes and lash margin.
AVENOVA NEWS | RX LID CLEANSER AIDS BLEPHARITIS, MGD
Rx Lid Cleanser Aids Blepharitis, MGD
9
9/29/2014 | Optometry Times
that posterior blepharitis/MGD is the
most common cause of DED. This is
important because MGD is a major
component of DED and contact lens
intolerance. Optometrists rated their
most important treatment goals for
anterior blepharitis:12
•	 Reduced symptoms: 44 percent
•	 Decreasing the bacterial load:
	 30 percent
•	 Reducing inflammation: 14 percent
According to the optometrists
surveyed, the most important product
attributes for the management of
blepharitis and MGD were: safety
beyond short-term exposure,
tolerability, dosing regimen, and
antibacterial properties. The two
most important factors for blepharitis
patients to seek treatment were
blepharitis symptoms (34 percent) and
dry eye symptoms (41 percent).
Clinicians should be aware of the
effect of blepharitis, dry eye, and other
disorders on contact lens patient
dropout rates. Mean rates in the U.S.
have been estimated at about 16
percent.13
A survey by Rumpakis found
the number one reason for dropouts in
the U.S. appeared to be discomfort (50
percent of respondents). Furthermore,
dropouts can constitute a substantial
loss of practice revenue.
The value of a contact
lens patient
Treatment paradigms for blepharitis
appear to be changing.12
Although,
lid hygiene is still important, the recent
trend is moving away from traditional
antibiotic ointments and toward
Rx products.
A new treatment option
The Avenova* product was developed
to enhance lid hygiene.
The cleanser is formulated with
0.01 percent hypochlorous acid,14
a
naturally occurring compound15
that
provides an oxidative burst produced
by neutrophils and monocytes.
Hypochlorous acid in solution is a fast-
acting/broad spectrum15-17
antimicrobial
agent, with >99.99 percent kill for
numerous pathogens including:
•	 S. aureus
•	 Methicillin-resistant S. aureus (MRSA)
•	 S. epidermidis
•	 H. influenzae
This rapid bacterial kill results in
reduced levels of bacterial toxins,
which would otherwise stimulate
the inflammatory cascade. Biofilms
are know to delay wound healing.18
Hypochlorous acid disrupts biofilms
in solution.19
This agent also reduces
bacterial loads in animal model
studies20
and is associated with
a low toxicity profile in solution.16
Hypochlorous acid has been used
successfully in other medical
applications such as nasal irrigation17
and wound therapy.14,16,20
Clinical experience with Avenova
Christine Sindt, OD, FAAO, associate
professor of clinical ophthalmology
at the University of Iowa Hospitals
and Clinics, manages patients with
blepharitis. She has been using the
hypochlorous acid cleanser with her
patients for several months and seen
positive results.
“We are constantly looking for better
treatments for their eyelid disease,”
she said. “We shouldn’t just be thinking
of blepharitis as a benign condition.
It can actually be viewed as very
devastating, both visually and in terms
of comfort for the patient.”
She also points out that it is important
to reduce the bacterial bioload on the
eyelid. She said this refers back
to Loretta Szczotka-Flynn’s work21
which shows people who have had
marginal infiltrative events have higher
lid flora than those who haven’t. Dr.
Sindt believes that the hypochlorous
acid cleanser should be given to every
contact lens wearer who has had a
contact lens peripheral ulcer. She also
feels the product has a benefit for any
patient who has rosacea.
“All of my patients have come back
and said that they have found this to
be very effective in making their eyes
more comfortable and increasing their
contact lens wear time,” said Dr. Sindt.
Others have even resumed contact
lens wear. She also pointed out that her
patients are experiencing reductions in
both itching and dry eye symptoms.
Art Epstein, OD, FAAO, who practices in
Phoenix, has had success with Avenova
and now keeps the product in stock
so that his patients have immediate
access to it. Previously, his patients
were using baby shampoos that were
stripping a lot of the oils from the skin,
which was a significant concern with
MGD and blepharitis. “In some cases
of lid disease,” he said, “the Staph
bacteria produce lipases, which lead to
saponification, and you end up with only
‘soaps’ on the lids, which is why patients
have burning eyes.”
Dr. Epstein said the hypochlorous acid
cleanser works effectively without the
detergent action and also counteracts
some of the toxins that are produced
by bacteria. Therefore, his patients get
a lot of relief using the product.
He noted that treatments for eyelid
disease have not changed for
a number of years and that the
hypochlorous acid cleanser is really
an ideal solution for a very prevalent
problem. The development of bacterial
resistance with the cleanser is not a
Continued on next page.
AVENOVA NEWS | RX LID CLEANSER AIDS BLEPHARITIS, MGD
Rx Lid Cleanser Aids Blepharitis, MGD
10
Rx Lid Cleanser Aids Blepharitis, MGD
9/29/2014 | Optometry Times
concern. His patients appreciate
Avenova’s results, not only in terms
of the efficacy and gentleness of
the product, but also in their overall
cosmetic appearance.
Use in therapeutic regimens
The 0.01 percent hypochlorous acid
eyelid cleanser has a useful place in
the therapeutic armamentarium for any
instance where enhanced lid hygiene
is needed:
•	 Blepharitis for better management
	 of signs and symptoms
•	 Dry eye (MGD) to decrease irritation
	 associated with dry eye
•	 Preoperative/perioperative care for
	 cataract, refractive, glaucoma
	 surgery, and retinal surgery
•	 After contact lens wear
•	 Other ocular irritation
How to create a dry eye center
Recolonization of bacteria can be
a chronic problem. For example,
women routinely reuse eye makeup
and inoculate themselves with bacteria
during each application. Rubbing
the eyes with the fingers can also
be a source of bacterial and allergen
contamination.
The cleanser can be used in place of
baby shampoo and other commercially
available lid scrubs. Data to be
presented this fall demonstrates that
the cleanser produces a faster
bacterial kill than other agents
that are currently available. The
product can be used in conjunction
with other products. It provides a
complimentary mechanism of action
to add to the treatment of Demodex
sp. It helps to prevent secondary
bacterial colonization and reduce the
inflammatory response caused by
exotoxins from the mites.
Dr. Epstein recommends the cleanser
for lid hygiene as a stand-alone agent.
He also has his patients use it in
conjunction with other agents, such as
antibiotics, for more severe cases of
MGD and blepharitis. In some cases,
the patients were able to discontinue
their antibiotic therapy after using
the cleanser. He also recommends
Avenova for his patients who have
undergone LipiFlow therapy.
Dr. Sindt often recommends a natural
oil product, such as coconut oil, to
soften the tissue around the eye and
help with cleaning the flaking debris.
She then has her patients use Avenova
to remove the bacterial bioburden
effectively on the eyelid surface.
The cleanser formulation does not
contain other buffers, preservatives,
or surfactants and is therefore gentle
enough for everyday use. This
contributes to one of the side-benefits
of the product that patients feel more
comfortable in their contact lenses or
are often even able to resume wearing
their lenses.
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
REFERENCES
1. Rosenfield M. Computer vision syndrome: a review of ocular causes and potential treatments. Ophthalmic Physiol Opt. 2011 Sep;31:502-15.
2. Bentivoglio AR, Bressman SB, Cassetta E, et al. Analysis of blink rate patterns in normal subjects. Mov Disord. 1997 Nov;12(6):1028-34.
3. Ellwein LB, Urato CJ. Use of eye care and associated charges among the Medicare population: 1991-1998. Arch Ophthalmol. 2002 Jun;120(6):804-11.
4. Lindsley K, Matsumura S, Hatef E, et al. Interventions for chronic blepharitis. Cochrane Database Syst Rev. 2012 May 16;5:CD005556.
5. Asbell PA. Increasing importance of dry eye syndrome and the ideal artificial tear: consensus views from a roundtable discussion. Curr Med Res Opin. 2006 Nov;22(11):2149-57.
6. American Academy of Ophthalmology. Preferred Practice Pattern Guidelines. Dry eye syndrome. San Francisco, CA: American Academy of Ophthalmology; 2011.
7. Albietz JM. Dry eye: an update on clinical diagnosis, management and promising new treatments. Clin Exp Optom. 2001 Jan-Feb;84(1):4-18.
8. Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs and symptoms in patients with dry eye disease. Cornea. 2004 Nov;23(8):762-70.
9. Nichols KK, Foulks GN, Bron AJ, et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9.
10. Lindstrom RL, Donnenfeld ED, Foulks GN, et al. Blepharitis 2010. Update on research and management. Ophthal Times. 2010; 1-15.
11. Foulks GN. Enhancing our knowledge of blepharitis. Ocul Surf. 2009 Apr;7(2 Suppl):S15-6.
12. Lemp MA, Nichols KK. Blepharitis in the United States 2009: a survey-based perspective on prevalence and treatment. Ocul Surf. 2009;7(2 Suppl):S1-14.
13. Rumpakis JMP. New data on contact lens dropouts: an international perspective. Rev Optom. 2010;1:1-4.
14. Crew JR, Varilla R, Rocas TAI, et al. Treatment of acute necrotizing fasciitis using negative pressure wound therapy and adjunctive neutrophase irrigation under the foam. Wounds. 2013; 25:272-7.
15. Albric M, McCarthy CA, Hurst JK. Biological reactivity of hypochlorous acid: implications for microbicidal mechanisms of leukocyte myeloperoxidase. Proc Natl Acad Sci USA. 1981 Jan;78(1):210-4.
16. Wang L, Bassiri M, Najafi R, et al. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr;6:e5.
17. Kim HJ, Lee JG, Kang JW, et al. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7.
18. Harrison-Balestra C, Cazzaniga AL, Davis SC, et al. A wound-isolated Pseudomonas aeruginosa grows a biofilm in vitro within 10 hours and is visualized by light microscopy. Dermatol Surg. 2003 Jun;29(6):631-5.
19. LeChevallier MW, Cawthon CD, Lee RG. Inactivation of biofilm bacteria. Appl Environ Microbiol. 1988 Oct;54(10):2492-9.
20. Robson MC, Payne WG, Ko F, et al. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming
the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr;6:e6.
21. Szczotka-Flynn L, Lass JH, Sethi A, et al. Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5421-30.
AVENOVA NEWS | RX LID CLEANSER AIDS BLEPHARITIS, MGD
11AVENOVA NEWS | NEW BLEPHARITIS TREATMENTS
A decade ago, we looked at
the latest treatment options
for blepharitis. It’s high time
we eye them up again.
We’ve been authoring the “Therapeutic
Review” column for 10 years now.
In one of our very first entries, “Put
a Lid on Blepharitis,” we discussed
the importance of differentiating
the various forms of blepharitis and
creating an individualized treatment
strategy for each patient.1
Like many procedures and protocols
in eye care, blepharitis management
has evolved during the last decade. It’s
time to revisit this topic and examine
some of the newest, most promising
treatment options.
Calling your bleph
A recently published survey of eye care
providers suggested that some form of
blepharitis is present in nearly half of
our patients––whether or not they are
symptomatic upon presentation.2
This
means that every practicing optometrist
likely sees this condition in one form or
another on a daily basis.
Unfortunately, our traditional therapies
for blepharitis have relied heavily
on ongoing patient-administered
intervention and compliance. Newer
treatment modalities not only provide
more targeted therapy, but also offer
the promise of rapid recovery for
most individuals.
Scrub-a-dub-dub
Lid scrubs have long been the
mainstay of blepharitis management.
Detergent-based products, such as
OcuSoft Lid Scrub or TheraTears
SteriLid, applied to the lids and lashes
help to remove accumulated debris
and excessive oils from the eyelid
margins. Also, these products diminish
bacterial reservoirs, combating the
overgrowth of flora that incites and
perpetuates staphylococcal blepharitis.
BlephEx
As mentioned previously, the
effectiveness of home-based lid scrubs
is directly contingent upon the patient’s
level of dexterity, thoroughness and
overall compliance. Recently, however,
RySurg introduced BlephEx—a
handheld device that allows physicians
to perform an in-office “deep
cleansing” of the lid margins. James
Rynerson, MD, principal developer
of BlephEx and CEO of Rysurg,
LLC, refers to this new treatment as
“microblepharoexfoliation.”
BlephEx is indicated for removal of lid
debris and microbial biofilm, which Dr.
Rynerson touts as the primary source
of all ocular surface inflammation. The
device incorporates a disposable,
high-speed, rotating microsponge
designed to clean both the anterior
and posterior lid margins, making it
appropriate for all forms of blepharitis.
In practice, we use BlephEx in cases
of staphylococcal and seborrheic
blepharitis, demodicosis and even
MGD as a form of debridement scaling
for the meibomian glands.3
Be aware that there is no ICD-9 code
associated with BlephEx at this time,
and thus no insurance coverage.
Patients’ out-of-pocket costs for the
procedure typically range from $150
to $200, or more in some cases. Like
dental cleanings, this procedure is
recommended semi-annually—or even
more frequently in severe cases.
Dropping Acid (on the Lids)
While surfactant cleaners certainly
have a role in blepharitis management,
they can be messy, irritating and
unpleasant for some patients.
Moreover, if conventional cleansers
fail to control bacterial replication
adequately, practitioners may need to
resort to more aggressive therapies,
such as topical antibiotics or antibiotic-
steroid combinations.
Continued on next page.
By Alan G. Kabat, OD, and Joseph W. Sowka, OD | 10/15/2014 | Review of Optometry
This 80-year-old woman presented
with severe blepharitis secondary
to Demodex folliculorum
infestation (top). Following
microblepharoexfoliation, she
exhibited improvement (bottom).
New Blepharitis Treatments
12AVENOVA NEWS | NEW BLEPHARITIS TREATMENTS
New Blepharitis Treatments
By Alan G. Kabat, OD, and Joseph W. Sowka, OD | 10/15/2014 | Review of Optometry
Avenova*
Recently, NovaBay Pharmaceuticals
introduced this novel antiseptic agent
specifically indicated for the treatment of
blepharitis. The company describes it as
“the first FDA 510K-cleared prescription
product to clean the lids and lashes,
removing the debris and microorganisms
that cause chronic inflammation.”
Avenova is a stabilized solution
comprised of 0.01% hypochlorous acid
(HOCl), a microbicidal component of the
innate immune system.4
HOCl is naturally
produced by neutrophils in response
to pathogenic organisms, and can kill
bacteria, block bacterial-derived toxins
and blunt the effects of human cell-
derived pro-inflammatory mediators.5,6
The product is packaged in a glass
bottle with a pump sprayer, and can
be applied to the lids via a cotton ball,
cosmetic pad or gauze. While there
aren’t yet any specific clinical studies
demonstrating its efficacy, colleagues
employing the product in their blepharitis
treatment regimen have noted
substantial improvement in both signs
and symptoms when applied BID for just
10 days.7
Avenova is sold exclusively
through physicians’ offices and online
by the manufacturer. It retails for
approximately $30 for a 40mL bottle.
Demodex Demolition
During the time that we’ve been writing
the “Therapeutic Review” column,
Demodex has gone from being a
vague, rarely-recognized and poorly
managed lid pathogen to one of the
most common causes of blepharitis
that we see in clinical practice. We’ve
known for some time that it is resistant
to most conventional lid cleansers
and antimicrobial agents, but is highly
responsive to tea tree oil.8
Cliradex
A recently published study identified
the most potent demodicidal element
in tea tree oil to be terpinen-4-ol, or
4-terpineol.9
This chemical compound
is the active ingredient in Bio-Tissue’s
Cliradex lid wipes. The company
suggests that it is “a natural,
preservative-free lid, lash and facial
cleanser that helps manage symptoms
associated with blepharitis, meibomian
gland dysfunction, rosacea, dry eye,
Demodex, chalazia and other lid
margin diseases.”
Since its release last September,
Cliradex has become a mainstay
treatment for our patients with
demodicosis and ocular rosacea
(which also seems to have a probable
association with Demodex).10
Also,
it has eliminated the need to obtain
pharmaceutically compounded agents
of varying concentrations for Demodex
infestation.
We typically prescribe Cliradex BID for 10
days, and then QD at bedtime for another
10 days in cases of Demodex blepharitis,
ideally after performing microblepharo-
exfoliation. The product is sold exclusively
through physicians’ offices and online,
and retails for about $40 per carton,
which contains 24 lid wipes.
Bio-Tissue also recently introduced
the Cliradex Complete kit, which
contains one carton of Cliradex lid
wipes, a tube of Cliradex Advanced
Care gel (a slightly more concentrated
version of 4-terpineol for in-office
application to the lids and lashes), a
dual-sided applicator and instructions
for the doctor and patient. This kit is
designed for use by eye care clinicians
only, and so individual providers
typically will determine patient cost
as a combination in-office/at-home
therapeutic procedure.
Time marches on––but fortunately,
each passing year brings a greater
understanding of the physical
maladies that plague our patients,
as well as provides us with new tools
to control their deleterious effects.
Even something as seemingly common
as blepharitis warrants consideration
and intervention to help improve
our patients’ vision and overall
quality of life.
We would also like to express our
gratitude to the editors who have
worked with us on this column
throughout the past 10 years, including
Jen Kirby, Leah Addis and especially
our current editor, Mike Hoster.
Dr. Kabat is a paid consultant to Bio-Tissue
and Alcon Laboratories. Neither he nor Dr.
Sowka has any direct financial interest in
the products mentioned.
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
REFERENCES
1. Kabat AG, Sowka JS. Put a lid on blepharitis. Rev Optom. 2004 Nov; 141(11):123-4.
2. Lemp MA, Nichols KK. Blepharitis in the United States 2009: A survey-based perspective on prevalence and treatment. Ocul Surf. 2009 Apr;7(2 Suppl):S1-S14.
3. Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7.
4. Wang L, Bassiri M, Najafi R, et al. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr 11;6:e5.
5. Gray MJ, Wholey WY, Jakob U. Bacterial responses to reactive chlorine species. Annu Rev Microbiol. 2013;67:141-60.
6. Ono T, Yamashita K, Murayama T, Sato T. Microbicidal effect of weak acid hypochlorous solution on various microorganisms. Biocontrol Sci. 2012;17(3):129-33.
7. Krader CG. Ophthalmology Times. Hypochlorous acid lid cleanser provides novel advantages. Available at: http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/hypochlorous-acid-lid-
cleanser-provides-novel-advantages. Accessed September 14, 2014.
8. Gao YY, Di Pascuale MA, Li W, et al. In vitro and in vivo killing of ocular Demodex by tea tree oil. Br J Ophthalmol. 2005 Nov;89(11):1468-73.
9. Tighe S, Gao YY, Tseng SC. Terpinen-4-ol is the most active ingredient of tea tree oil to kill Demodex mites. Transl Vis Sci Technol. 2013 Nov;2(7):2.
10. Holmes AD. Potential role of microorganisms in the pathogenesis of rosacea. J Am Acad Dermatol. 2013 Dec;69(6):1025-32.
13
New Eye Treatment Is “One of the Best
Tools I’ve Found,” Patient Reports
10/30/2014 | Eye Institute
An informal survey of
doctors and patients
finds that NovaBay
Pharmaceuticals’ Avenova
is improving the quality
of patients’ lives all
across the U.S.
The Eye Institute, located in Marin
County, California, announced today
that an informal nationwide survey
of eye doctors and patients shows
success with the use of a recently
launched product, Avenova*, as part of
the treatment for Evaporative Dry Eye
Syndrome associated with Blepharitis
and Meibomian Gland Dysfunction.
The condition is the result of over-
colonization of Staph bacteria, resulting
in inflammation of eye lids and
blockage of meibomian glands that
help lubricate the eye surface. “We’re
finding this innovative product has
had significant impact in helping many
patients,” said Kathryn Najafi-Tagol,
MD, Founder and Medical Director of
the Eye Institute.
One grateful patient in the survey is
Ramsey Flynn of Towson, Maryland.
Blepharitis “has impaired my life for over
20 years,” Flynn reported. But recently,
his eye doctor, renowned eye surgeon
Sheri Rowen, MD, introduced him to what
he described as “a remarkably simple
prescription called Avenova. It’s a gentle
solution that I can spray onto a cotton
ball and wipe across my closed eyelids.”
The product finally brought him relief.
“It’s one of the best tools I’ve found
in my fight against the unruly beast
of blepharitis,” he reported. “Much
recommended!”
Dr. Rowen commented, “Blepharitis is
an often very uncomfortable and can be
a chronic condition where Staphylcocci
bacteria grow on eyelids, causing swelling,
redness, inflammation, irritation, a crusty
build-up. It often causes enough
inflammation to block the Meibomian
glands that provide lubrication to the
surface of cornea. This is a widespread
problem affecting an estimated 23
million sufferers across the United States.”
Avenova is made by NovaBay®
Pharmaceuticals, Inc. (NYSE MKT: NBY)
and has been cleared by the FDA as a
skin and wound cleanser. It has in-vitro
broad antimicrobial activity because
of NovaBay’s proprietary ingredient,
Neutrox™, which mimics the substance
used by white blood cells as their first
line of defense against bacteria and
other microbial invaders. Lab tests also
show Neutrox not only kills bacteria,
it also neutralizes the bacterial toxins
that contribute to Blepharitis and
associated dry eye syndrome.
John Moore, a retired professional
from Walnut Creek, CA, is another
satisfied patient. He suffered from
Blepharitis for over ten years. Nothing
brought him relief—until he was
prescribed Avenova. “I am so happy
with the results,” he reported.
Similarly, other Blepharitis patients—
and their doctors—say that Avenova
has finally brought them relief.
The survey also asked ophthalmologists
and optometrists for their experiences
with Avenova. A sampling of responses:
— “I have to say that it really is amazing
and patients love it,” reported Scott
Kamena, O.D., at Murrieta Optometry
in Livermore, CA.
— “Under the microscope on a wet
prep done by two of our interested
O.D.’s who specialize in Ocular Surface
Disease, NovaBay Avenova appears
to kill Demodex,” said Dick Lindstrom,
M.D., founder and attending surgeon
of Minnesota Eye Consultants as well
as Adjunct Clinical Professor Emeritus
at the Department of Ophthalmology,
University of Minnesota and Chair,
ASCRS Foundation.
— “NovaBay Avenova offers a long
term solution and is a safe option for the
management of over colonized lid flora,”
wrote Eric Donnenfeld, M.D., F.A.C.S.
National Medical Director of TLC Laser
Eye Centers, based in Connecticut,
New York and New Jersey.
— “We have had very nice results,”
wrote S. Barry Eiden, O.D., F.A.A.O.,
President and Medical Director of
North Suburban Vision Consultant, Ltd.
and assistant clinical professor at the
University of Illinois, Chicago.
— “I’ve been using it for a few months
and I am impressed with it. Patients
seem to like it and appear improved on
it,” wrote Steven G. Safran, M.D., PA, an
ophthalmologist in Lawrenceville, NJ.
— “i-Lid has been a huge improvement
over soap-based lid scrubs,” reported
Susan J. Gromacki, O.D., M.S., F.A.A.O.
of Washington Eye Physicians &
Surgeons in Chevy Chase, MD.
Kathyrn Najafi-Tagol, MD
(Ophthalmologist)
The Eye Institute
415-444-0300
AVENOVA NEWS | NEW EYE TREATMENT IS “ONE OF THE BEST TOOLS I’VE FOUND,” PATIENT REPORTS
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
14
11/2014 | Primary Care Optometry News
Clinicians can look beyond
eye drops for options to
treat dry eye, blepharitis
and meibomian gland
dysfunction
Schaeffer recommends the
compresses to other doctors,
with one note of caution.
“It’s important to keep a clean
environment, and heating these
masks in the office in a microwave
that’s used for food is not good
medical technique,” he explained.
“I highly suggest buying a small
microwave just for the compresses.”
Cliradex lid hygiene kit
The Cliradex Complete Advanced
Lid Hygiene Kit (Bio-Tissue), which
contains a gel as well as cleansing
wipes, “represents a significant
advantage over other commercially
produced blepharitis kits as well as the
‘homemade’ versions involving
diluted concentrations
of raw tea tree oil,”
according to Scott G.
Hauswirth, OD, FAAO,
a PCON Editorial
Board member.
He noted that he uses it for in-office
treatments of aggressive blepharitis,
especially types involving Demodex
mites.
“It contains the active ingredient in
tea tree oil, 4-terpineol, in a topical
cream,” Hauswirth explained. “There is
a double-sided applicator included, as
well as a box of Cliradex wipes.”
Hauswirth prefers using the Cliradex kit
for multiple reasons, he told PCON.
“First, studies have shown that
4-terpineol is more effective with a
faster kill rate than raw tea tree oil,”
he said. “Second, the cream-like
consistency of the product makes for
safer application to the lids and lash
base, so there is less likely a chance
of over-application and resultant oil
draining into the eye. Third, the thicker
consistency means longer residence
time on the surface with potentially
greater potency against the offending
organism.”
Patients are complaining less of
discomfort and irritation after using the
product, Hauswirth has found.
“From an integration standpoint, it is
an easy adjustment to this kit from the
product we were using prior,” he said.
“I generally do two applications of the
4-terpineol cream at the visit, then
give the patient a carton of Cliradex
cleansing wipes to use at home on
the eyelids.”
Hauswirth said the Cliradex wipes are
sold in his optical, but that he uses the
Cliradex kit as an in-office application.
Avenova
Katherine Mastrota,
MS, OD, FAAO,
has found Avenova*
(NovaBay), a
prescription solution,
to be “an excellent
adjunct to familiar
commercially available and well
established products.
“Avenova is a lid hygiene maintenance
product,” she explained. “It is a
bottled, liquid solution containing
Neutrox, which is pure hypochlorous
acid. Clinically, hypochlorous acid is
generated in activated neutrophils
and contributes to the destruction of
bacteria. The solution is non-sensitizing
and oxidizes quickly after application,
so it is ideal for de-bulking microbial
load and the associated biofilms from
the eyelash base and lid margins.”
Mastrota told PCON that she has
investigated the product on numerous
types of patients, including those with
dry eye complicated with meibomian
gland dysfunction and blepharitis,
those with atopic dermatitis, ocular
rosacea or mild blepharoconjunctivitis
as well as contact lens wearers.
For those in whom she also prescribes
hot compress therapy, she suggests
they use the Avenova first.
“It makes sense to me to de-bulk
the lids both mechanically and
therapeutically before a compress
process,” Mastrota said.
“I generally show patients the spray-
delivered product in the office,
describe how to use it and send them
with a prescription for their pharmacist
to supply it,” she said. “I explain to
them that although the product has a
chlorine-like scent, it will not sting as
they might expect.
Mastrota told PCON that NovaBay
has early evidence that Avenova is
acaracidal. From white paper studies,
however, they have in vitro evidence
that the hypochlorous acid solution
Continued on next page.
AVENOVA NEWS | ALTERNATIVE PRODUCTS AVAILABLE TO COMBAT OCULAR SURFACE DISEASE
Alternative Products Available to
Combat Ocular Surface Disease
15
Alternative Products Available to
Combat Ocular Surface Disease
11/2014 | Primary Care Optometry News
AVENOVA NEWS | ALTERNATIVE PRODUCTS AVAILABLE TO COMBAT OCULAR SURFACE DISEASE
has significant activity against a host
of microbes, both gram-positive and
gram-negative.
“It is presumed from these studies that
iLid Cleanser would be efficacious
against Bacillus oleronius, a Demodex-
associated bacteria,” she said. “The
bacillus may incite pathology as
opposed to the mite.”
The only suggestion she has in terms
of product improvement is the addition
of an adjunct surfactant product.
“As Avenova contains only Neutrox and
saline, it has no surfactant properties,”
she said. “It will not remove most
eye makeup, nor is it designed to
do so. Akin to the dermatology and
cosmetology practice of ‘cleaner and
toner,’ Avenova, in my mind, is best
used after makeup remover with
a doctor-recommended surfactant
product. Going forward, I would like
to see a paired surfactant product
as well as application pads added to
Avenova.”– by Chelsea Frajerman
FOR MORE INFORMATION:
Scott G. Hauswirth, OD, FAAO, is a
Primary Care Optometry News Editorial
Board member. He is a member of the
Minnesota Eye Consultants clinical staff,
leads the optometric student externship
program at Minnesota Eye Consultants and
is adjunct faculty at the Southern California
College of Optometry as well as the Illinois
College of Optometry. He can be reached
at sghauswirth@mneye.com.
Katherine Mastrota, MS, OD, FAAO, is
the center director of Omni Eye Surgery
in New York. She can be reached at
katherinemastrota@msn.com.
Jack Schaeffer, OD, specializes in general
optometry. He is the president and CEO
of Schaeffer Eye Center, which has 16
locations in Alabama. He can be reached at
drschaeffer@schaeffereyecenter.com.
Steve Silberberg, OD, practices in
New Jersey. He can be reached at
spacedoc@alum.mit.edu.
Disclosures: Hauswirth is a consultant to
Bio-Tissue. Mastrota is on the advisory boards
of Bio-Tissue and NovaBay. Schaeffer has
attended an advisory board meeting for Bruder.
Silberberg is a consultant for Bausch + Lomb and
CooperVision.
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
REFERENCE
McMahon F, et al. Invest Ophthalmol Vis Sci. 2014; doi: 10.1167/iovs.14-15018. Accessed October 20, 2014.
16
New Study Shows Effectiveness
of Avenova
11/20/2014 | VMail Technology
AVENOVA NEWS | NEW STUDY SHOWS EFFECTIVENESS OF AVENOVA
Product: Avenova
Top Line: The Eye Institute,
located in Marin County,
Calif., recently announced
that an informal nationwide
survey of eye doctors
and patients shows
success with the use of a
recently launched product,
Avenova from NovaBay
Pharmaceuticals, to treat
Evaporative Dry Eye
Syndrome associated with
Blepharitis and Meibomian
Gland Dysfunction.
The condition is the result of over-
colonization of Staph bacteria, resulting
in inflammation of eye lids and blockage
of meibomian glands that help lubricate
the eye surface. “We’re finding this
innovative product has had significant
impact in helping many patients,” said
Kathryn Najafi-Tagol, MD, founder and
medical director of the Eye Institute.
Close Up: Avenova has
broad in-vitro antimicrobial
activity and has been
cleared by the FDA as a
skin and wound cleanser.
Avenova* maintains its antimicrobial
activity by the use of NovaBay’s
proprietary ingredient, Neutrox, which
contains the same active ingredient
used by white blood cells as their first
line of defense against bacteria and
other microbial invaders. Lab tests
show Neutrox not only kills bacteria, it
also neutralizes the bacterial toxins that
contribute to blepharitis and another
condition called dry eye syndrome.
Vital Stats: The active ingredient in
Avenova is a proprietary pure and
stable form of hypochlorous acid or
HOCI. HOCI is a bacterial component
of the innate immune system.
Incorporation into a commercial product
required Dr. Najafi-Tagol to engineer
a formulation that would maintain the
stability of the acid and avoid other
impurities. Results from pharmaceutical
laboratory studies conducted
by NovaBay Pharmaceuticals in
coordination with Dr. Najafi-Tagol’s
Eye Institute evaluating the stabilized
hypochlorous acid proved that it has
fast-acting, broad-spectrum activity
against microorganisms found in
the external ocular flora plus the
ability to disrupt biofilm that harbors
bacteria. Dr. Najafi-Tagol’s testing also
established that Avenova is non-toxic
to human tissues, non-irritating, and
hypoallergenic.
Avenova is available by prescription
only. It comes in a 40ml glass bottle with
a fine mist spray pump included. The
product has recently been added to
the Vision Source Network, and is also
available through local pharmacies and
major retail chains across the U.S., such
as Wal-Mart, Costco, CVS and Target,
through a distribution agreement
between NovaBay Pharmaceuticals
and McKesson Corp. Click here to
see a video about Avenova.
www.avenova.com
(800) 890-0329
*The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.

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Avenova News Booklet

  • 1. Avenova News AVENOVA.COM | 1 -8 0 0-8 9 0 -0 32 9 Daily lid and lash hygiene.
  • 2. 2AVENOVA NEWS | LETTER FROM RON NAJAFI, PH.D., CHAIRMAN & CEO OF NOVABAY PHARMACEUTICALS Letter from Ron Najafi, Ph.D., Chairman & CEO of NovaBay Pharmaceuticals Dear Friend, Welcome to the first edition of Avenova News, a booklet of reprinted articles about our revolutionary eye care product. We at NovaBay believe that Avenova is a breakthrough in eye care. It is the first prescription, non-detergent, non-antibiotic antimicrobial eye care product on the market. It is proving to be remarkably safe and an important component of the regimen for the successful management of blepharitis, meibomian gland dysfunction and associated dry eye syndrome. But please don’t just take my word for it. A number of prominent ophthalmologists and optometrists have been writing articles that explain what’s unique about Avenova and how it works to improve the quality of care for countless patients. In addition, the eye care trade press has been covering the introduction of Avenova and the evidence of its benefits. It is also worth mentioning that Avenova contains Neutrox™, the purest Hypochlorous acid commercially available today, with no bleach impurities. We will be producing more editions of Avenova News on a regular basis as more educational news material is published. In the meantime, please enjoy reading what others have been writing about our product. Ron Najafi, Ph.D. Chairman & CEO NovaBay Pharmaceuticals, Inc.
  • 3. 3AVENOVA NEWS | CONTENTS Contents 2 4 5 7 8 11 13 14 16 Letter from Ron Najafi, Ph.D., Chairman & CEO of NovaBay Pharmaceuticals Wash Away Your Old Hygiene Strategy Christine W. Sindt, OD | Review of Cornea & Contact Lenses (RCCL) Hypochlorous Acid Lid Cleanser Provides Novel Advantages Featuring Kathryn Najafi, MD and Steven Lichtenstein, MD | Ophthalmology Times New Avenova Effectively Treats Common Eye Problems in Elderly, Says Phoenix Optometrist Dr. Arthur B. Epstein | Phoenix Eye Care Rx Lid Cleanser Aids Blepharitis, MGD Optometry Times New Blepharitis Treatments Alan G. Kabat, OD, and Joseph W. Sowka, OD | Review of Optometry New Eye Treatment Is “One of the Best Tools I’ve Found,” Patient Reports Kathryn Najafi, MD | Eye Institute Alternative Products Available to Combat Ocular Surface Disease Featuring Katherine Mastrota, MS, OD, FAAO | Primary Care Optometry News New Study Shows Effectiveness of Avenova VMail Technology *The name of “i-Lid Cleanser” has been changed to “Avenova” in the above articles to reflect the rebranding that occurred in January 2015.
  • 4. 4AVENOVA NEWS | WASH AWAY YOUR OLD HYGIENE STRATEGY Wash Away Your Old Hygiene Strategy By Christine W. Sindt, OD | 5/15/2014 | Review of Cornea and Contact Lenses (RCCL) *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015. REFERENCES 1. McCann LC, et al. Tear and meibomian gland function in blepharitis and normals. Eye Contact Lens. 2009 Jul;35(4):203-8. 2. Panaser A, Tighe BJ. Evidence of lipid degradation during overnight contact lens wear: gas chromatography mass spectrometry as the diagnostic tool. IOVS. March 2014;d55(3):1798. 3. Craig JP, et al. The TFOS international workshop on contact lens discomfort: report of the contact lens interactions with the tear film subcommittee. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS71-97. 4. Willcox MD, et al. Potential sources of bacteria that are isolated from contact lenses during wear. Optom Vis Sci. 1997 Dec; 74(12):1030-8. 5. Stapleton F, et al. Changes to the ocular biota with time in extended- and daily-wear disposable contact lens use. Infect Immun. 1995 Nov; 63(11):4501-5. 6. Welling JD, et al. Chronic eyelid dermatitis secondary to cocamidopropyl betaine allergy in a patient using baby shampoo eyelid scrubs. JAMA Ophthalmol. 2014 Mar 1;132(3):357-9. Early impressions of a new eyelid cleansing option to help keep your patients’ eyes clean and microbe-free It really is no secret that clean eyelids promote healthy contact lens wear. As we’ve all seen clinically, patients who have blepharitis exhibit significant differences in tear physiology than those without blepharitis.1 Tear lipids are oxidatively stable in their native environment because meibomian glands predominantly secrete only saturated and monounsaturated lipids.2 Stable lipids don’t degrade and don’t cause discomfort or blur. Blepharitis and meibomian gland dysfunction (MGD) patients typically experience heavy deposits of lipids on their lenses. This phenomenon is not limited to these patients, however. These lipid deposits may also be seen in those with no apparent MGD due to the individual composition of the meibum. Over time, lipids associated with the contact lens will become unstable and degrade. Once formed, these deposits impair optical quality and the wettability of the lens surface (with the latter resulting in a quick break-up of the tear film), which can eventually lead to intolerance to contact lens wear.3 In addition to affecting the tear film, vision and comfort, the lids play host to myriad microorganisms. Bacterial contamination of soft lenses is associated with microbial keratitis and corneal inflammatory events. Normal ocular organisms include coagulase-negative Staphylococci, Corynebacterium species, Micrococcus species, Bacillus species and Propionibacterium species.4 The lid margin, commonly colonized by microbes, is found to harbor organisms up to 70% of the time.5 Additionally, substantial lid bioburden is associated with a 2.5-fold greater risk of substantial lens bioburden, and is likely the major route of lens contamination.5 A New Option Keeping the lids clean, which in turn keeps the lens clean, directly benefits patient comfort, safety and quality of vision. The “old-school” lid hygiene method included the use of diluted baby shampoo to remove debris and contaminants. While it remains convenient and inexpensive, this is not as safe or simple as it may sound. Baby shampoos—as well as some eyelid cleansers—contain cocamidopropyl betaine, a surfactant and lathering agent that may cause an eyelid dermatitis.6 Surfactants, the key ingredient in most lid scrub products, are also known to dry the skin and strip the area of oil— ironically, inducing increased production of oil in the glands. A novel product, Avenova* (NovaBay Pharma­ceuticals), which contains pure hypochlorous acid 0.01%, offers practitioners a new option for lid hygiene. Hypochlorous acid is a naturally occurring chemical released by neutrophils to kill microorganisms and neutralize toxins released from pathogens and inflammatory mediators. As it is neutralized quickly, it’s nontoxic to the ocular surface. Other hypochlorous acid products (e.g., Dakin) contain impurities (such as bleach), which are toxic to the ocular surface. In my experience, Avenova offers excellent lid cleansing capability without extraneous ingredients such as surfactants. Pure hypochlorous acid 0.01% has shown to be fast acting against the five major bacterial pathogens associated with blepharitis during in-vitro laboratory tests. Although some conventional lid scrubs may lack antimicrobial activity even after prolonged exposure, efficacy of pure hypochlorous acid 0.01% was documented after just seconds of exposure, according to NovaBay Pharmaceuticals. In direct comparisons, the company says, pure hypochlorous acid 0.01% demonstrated a similar antibacterial spectrum of activity to Betadine—with 1,000 times less toxicity. Its antibacterial properties make Avenova a welcome addition to any blepharitis or MGD-related dry eye treatment regimen. Additionally, the product can be useful in make-up removal and as an adjunct to contact lens wear.
  • 5. 5AVENOVA NEWS | HYPOCHLOROUS ACID LID CLEANSER PROVIDES NOVEL ADVANTAGES 6/1/2014 | From Ophthalmology Times New product associated with excellent results, high patient acceptance in management of blepharitis A novel eye-care product containing a stabilized form of pure hypochlorous acid (0.01%) in saline (Advanced Avenova*, NovaBay) offers a safe and effective alternative for cleansing the lids, lashes, and periocular skin of debris and microorganisms, which can cause irritation, inflammation, and ocular surface disease. Hypochlorous acid is a bactericidal component of the innate immune system. Incorporation into a commercial product required engineering a formulation that would maintain the stability of the acid and avoid other impurities. Results from laboratory studies evaluating the stabilized hypochlorous acid show it has fast-acting, broad-spectrum activity against microorganisms found in the external ocular flora, including methicillin- resistant Staphylococcus aureus, plus the ability to disrupt biofilm that harbors bacteria. Laboratory testing has also established that the product is non-toxic to human tissues and non-irritating. Merits of hypochlorous acid cleanser Kathryn Najafi-Tagol, MD, founder, Eye Institute of Marin, San Rafael, CA, has been involved in research evaluating the properties of hypochlorous acid. In clinical practice, she has found that when used in the management of blepharitis, the lid cleanser is associated with excellent results and high patient acceptance. “Blepharitis is a common problem seen by eye-care practitioners. It can have cosmetic, structural, and functional sequelae, and the availability of different options for use by affected patients is desirable,” Dr. Najafi-Tagol said. “Based on its unique characteristics, the hypochlorous acid cleanser is a welcome addition to our toolbox. “In my experience, it is extremely helpful, and I appreciate that unlike topical antibiotics and steroids, it can be used safely on a regular, ongoing basis,” she said. “Furthermore, the hypochlorous acid cleanser is a simple and elegant formulation with reduced potential to cause skin irritation compared with other commercial lid cleansers containing buffering ingredients, surfactants, and preservatives. My patients have been very pleased with the product, enjoying not only its efficacy as a cleanser but also what many describe as a refreshing feeling.” Managing blepharitis Steven J. Lichtenstein, MD, associate professor of clinical surgery and pediatrics, University of Illinois College of Medicine at Peoria and Chicago, and medical director of pediatric ophthalmology, Children’s Hospital of Illinois, Peoria, said he first began recommending the hypochlorous acid cleanser for use by patients with blepharitis at the beginning of 2014, and the results achieved have been excellent. Dr. Lichtenstein noted that his standard treatment for children with chronic blepharitis has been dilute baby shampoo lid scrubs combined with a topical antibiotic and a steroid as needed to control significant inflammation. With this regimen, however, he was always concerned about the development of bacterial resistance and steroid-related complications, especially considering the likelihood that parents might be initiating repeat treatment on their own using medication leftover from a previous prescription. Continued on next page. BEFORE AFTER Hypochlorous Acid Lid Cleanser Provides Novel Advantages
  • 6. 6AVENOVA NEWS | HYPOCHLOROUS ACID LID CLEANSER PROVIDES NOVEL ADVANTAGES Hypochlorous Acid Lid Cleanser Provides Novel Advantages “The hypochlorous acid cleanser is not any harder or any easier to use than the dilute baby shampoo, but it seems to provide better results while eliminating or reducing the need for antibiotics and steroids along with their associated costs and concerns,” he said. The cleanser is packaged in a spray top bottle and should be dispensed onto a cotton pad or cotton-tipped applicator that is then used to scrub along the lashes, lids, and as needed, the periocular skin. Dr. Najafi-Tagol noted that she only suggests a cotton-tipped applicator when she is confident the patient will be able to use it safely and confirms her impression by asking patients to demonstrate their technique before they leave the office. Both Dr. Najafi-Tagol and Dr. Lichtenstein said they have used the lid cleanser for the management of patients with both anterior and posterior blepharitis. In patients with meibomian gland dysfunction (MGD), the lid cleanser is combined with other lid hygiene methods, such as warm compresses directed at relieving gland obstruction, Dr. Najafi-Tagol said. “Using the lid cleanser to reduce the bacterial burden on the eyelids is useful in patients with MGD because the organisms produce exotoxins and lipases that can lead to the development of evaporative dry eye disease through their inflammatory properties and effects on the meibomian gland secretions,” she explained. Dr. Lichtenstein said he recommends twice-daily use of the lid cleanser, in the morning and at bedtime. So far, it has been consistently effective, with resolution occurring in some patients within 2 weeks. “I have not yet seen any child whose blepharitis has recurred after the successful use of this regimen incorporating the lid cleanser,” he said. “However, because of the safety of this product, I am comfortable telling parents that they can re-initiate its use if they notice returning signs of redness or debris.” Steven J. Lichtenstein, MD eyedoc44@aol.com Dr. Lichtenstein has no relevant financial interest to disclose. Kathryn Najafi-Tagol, MD kn@najafimd.com Dr. Najafi-Tagol is also a member of NovaBay’s Ophthalmic Advisory Board and serves as medical monitor for NovaBay’s conjunctivitis clinical trials. 6/1/2014 | From Ophthalmology Times *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
  • 7. 7AVENOVA NEWS | NEW AVENOVA EFFECTIVELY TREATS COMMON EYE PROBLEMS IN ELDERLY, ... New Avenova Effectively Treats Common Eye Problems in Elderly, Says Phoenix Optometrist By Dr. Arthur B. Epstein | 6/11/2014 | Phoenix Eye Care In a recent webinar, Dr. Arthur B. Epstein of Phoenix Eye Care explains how Avenova can alleviate the suffering from blepharitis and other common eye conditions, such as dry eye syndrome, in the elderly Dr. Arthur Epstein, Director of the Dry Eye - Ocular Surface Disease Center and Director of Clinical Research at Phoenix Eye Care, announced in a recent webinar that the elderly now have a potent new solution for eye problems such as inflammation of the eyelids associated with blepharitis and dry eye syndrome. These eye conditions are especially common in Arizona because of the large number of retirees and the desert climate, said Dr. Epstein. The new treatment is Avenova*. It was discovered and developed by Kathryn Najafi-Tagol, MD, Founder and Medical Director of the Eye Institute of Marin in Marin County, California and scientists from NovaBay Pharmaceuticals (NYSE MKT: NBY) in Emeryville, Calif. Avenova is preserved by a stable form of hypochlorous acid, a substance naturally made by the body’s immune system as a first defense against microbial invaders. Lab tests show that Avenova not only kills bacteria, it also neutralizes the toxins produced by bacteria and is also completely safe to skin around the eye. The Food & Drug Administration has cleared Avenova for the removal of foreign material, including microorganisms, from skin. “Those properties made Avenova an ideal treatment for eye conditions,” Dr. Epstein explained. “Blepharitis is the most common and most visible problem that eye care professionals encounter,” he said. “We see a tremendous amount in our practice in Phoenix.” Blepharitis is typically caused by Staph bacteria that grow on eyelids, causing swelling, redness, inflammation, irritation and a crusty build-up. “It can be very irritating,” Dr. Epstein said. “The Avenova safely removes the bacteria and the crusty material, providing significant relief.” Doctors have been using Avenova regularly at Phoenix Eye Care and at the Eye Institute of Marin to treat blepharitis, as this video and this product backgrounder explain. “Two-thirds of the patients I see are coming in for dry eye therapy,” said Dr. Epstein. Dry eye is typically a result of meibomian gland disease, where the growth of Staph bacteria cause the meibomian glands to be obstructed by thick waxy secretions, causing dry eye. The Avenova removes both the bacteria and the bacterial toxins from eye lids and lashes. “It has tremendous utility for this condition,” said Dr. Epstein. “Overall, control of lid flora is one of the most important things we can do as physicians,” said Dr. Epstein. Now, Avenova makes that possible. Phoenix Eye Care, PLLC and the Dry Eye Center of Arizona, PLLC combine the skills and experience of two highly respected optometrists, a caring staff and state-of-the-art instrumentation and diagnostic equipment. Phoenix Eye Care provides a full range of primary eye care services including comprehensive eye examinations, LASIK evaluations, pre-and post-operative management, contact lenses, diabetic eye examinations and much more. Contact: Dr. Arthur B. Epstein Phoenix Eye Care Phone: (602) 549-2020 Fax: (602) 325-5536 Email: phxeyecare@gmail.com *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015. SOURCE: Phoenix Eye Care
  • 8. 8 9/29/2014 | Optometry Times Contact lens wearers also see benefit Everything from our high-tech lifestyles1 outdoor environmental factors, and the general aging of the population can lead to blepharitis, dry eye disease (DED) and meibomian gland dysfunction (MGD). Sustained tasks, such as reading, can reduce the blink rate to as low as five blinks per minute.2 This slow blink rate can cause additional stress on an ocular surface that is already compromised due to one of the aforementioned disorders. It is not surprising that the limited prevalence data currently available suggest ocular disorders, such as dry eye, are increasing in prevalence.3 Patients experience discomfort as well as reductions in both productivity and overall quality of life. Blepharitis, for example, tends to be a chronic condition, and no one treatment has proven curative thus far.4 Some of the treatments used for these ocular diseases have included: lid scrubs, mild shampoos, warm compresses, and antibiotic ointments. The FDA recently cleared the novel Rx eyelid cleanser (NovaBay Pharmaceuticals, Inc.), which is designed to enhance lid hygiene and help to alleviate these conditions. Assess dry eye from a systemic standpoint DED, MGD, and blepharitis DED is typically the result of insufficiency of tear quality or volume, which leads to inadequate lubrication of the ocular surface.5 A variety of signs and symptoms are associated with DED, including: grittiness, burning, irritation, foreign body sensation, redness, fluctuating vision, and increased blink rate.6,7 The link between the signs and symptoms of DED has proven inconclusive to date.8 MGD is one of the leading causes of DED throughout the world.9 The Tear Film and Ocular Surface Society (TFOS) described MGD as “a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion.”9 Blepharitis is one of the most common eye disorders,10,11 but the condition often goes undiagnosed due to the fact that it can sometimes be perceived by the patient as being a nuisance rather than a legitimate medical concern. Blepharitis is an inflammatory disease of the lid margin with a multifactorial etiology.10 This condition encompasses pathologic conditions of the pilosebaceous unit of the anterior lid or the meibomian gland of the posterior lid.12 The anterior form is usually caused by bacterial overgrowth and/or sebaceous gland activity, while the posterior form is caused by MGD, the most common causative factor for evaporative dry eye. Blepharitis is typically diagnosed using several hallmark signs and symptoms including:12 • Heavy/puffy eyelids • Itching/burning eyelids • Dry, irritated eyes • Crusting or flaking of the lids on awakening Currently, there is a paucity of prevalence data regarding blepharitis.10,11 This is due, in part, to the fact that the disease often exists as a comorbid condition with DED, seborrheic dermatitis, atopy, acne rosacea, etc.,12 which makes a differential diagnosis more challenging. To address this knowledge gap and increase our understanding of blepharitis, Lemp and Nichols conducted a survey of 5,000 individuals in the U.S. and found that 79.3 percent had experienced at least one symptom related to blepharitis during the previous 12 months.12 Furthermore, 32 percent of respondents experienced at least one symptom half of the time. Lemp and Nichols also surveyed 120 ophthalmologists and 84 optometrists to evaluate the frequency of ocular surface symptoms associated with blepharitis.12 About 47 percent of optometry patients and 37 percent of ophthalmology patients were suffering from these symptoms. Most ODs (97 percent) agreed or strongly agreed that DED is a common comorbidity with blepharitis/MGD. Most (94 percent) of ODs agreed or strongly agreed Continued on next page. BEFORE AND AFTER: These images show a patient’s lid both before and after usage of Avenova. Note the difference in lashes and lash margin. AVENOVA NEWS | RX LID CLEANSER AIDS BLEPHARITIS, MGD Rx Lid Cleanser Aids Blepharitis, MGD
  • 9. 9 9/29/2014 | Optometry Times that posterior blepharitis/MGD is the most common cause of DED. This is important because MGD is a major component of DED and contact lens intolerance. Optometrists rated their most important treatment goals for anterior blepharitis:12 • Reduced symptoms: 44 percent • Decreasing the bacterial load: 30 percent • Reducing inflammation: 14 percent According to the optometrists surveyed, the most important product attributes for the management of blepharitis and MGD were: safety beyond short-term exposure, tolerability, dosing regimen, and antibacterial properties. The two most important factors for blepharitis patients to seek treatment were blepharitis symptoms (34 percent) and dry eye symptoms (41 percent). Clinicians should be aware of the effect of blepharitis, dry eye, and other disorders on contact lens patient dropout rates. Mean rates in the U.S. have been estimated at about 16 percent.13 A survey by Rumpakis found the number one reason for dropouts in the U.S. appeared to be discomfort (50 percent of respondents). Furthermore, dropouts can constitute a substantial loss of practice revenue. The value of a contact lens patient Treatment paradigms for blepharitis appear to be changing.12 Although, lid hygiene is still important, the recent trend is moving away from traditional antibiotic ointments and toward Rx products. A new treatment option The Avenova* product was developed to enhance lid hygiene. The cleanser is formulated with 0.01 percent hypochlorous acid,14 a naturally occurring compound15 that provides an oxidative burst produced by neutrophils and monocytes. Hypochlorous acid in solution is a fast- acting/broad spectrum15-17 antimicrobial agent, with >99.99 percent kill for numerous pathogens including: • S. aureus • Methicillin-resistant S. aureus (MRSA) • S. epidermidis • H. influenzae This rapid bacterial kill results in reduced levels of bacterial toxins, which would otherwise stimulate the inflammatory cascade. Biofilms are know to delay wound healing.18 Hypochlorous acid disrupts biofilms in solution.19 This agent also reduces bacterial loads in animal model studies20 and is associated with a low toxicity profile in solution.16 Hypochlorous acid has been used successfully in other medical applications such as nasal irrigation17 and wound therapy.14,16,20 Clinical experience with Avenova Christine Sindt, OD, FAAO, associate professor of clinical ophthalmology at the University of Iowa Hospitals and Clinics, manages patients with blepharitis. She has been using the hypochlorous acid cleanser with her patients for several months and seen positive results. “We are constantly looking for better treatments for their eyelid disease,” she said. “We shouldn’t just be thinking of blepharitis as a benign condition. It can actually be viewed as very devastating, both visually and in terms of comfort for the patient.” She also points out that it is important to reduce the bacterial bioload on the eyelid. She said this refers back to Loretta Szczotka-Flynn’s work21 which shows people who have had marginal infiltrative events have higher lid flora than those who haven’t. Dr. Sindt believes that the hypochlorous acid cleanser should be given to every contact lens wearer who has had a contact lens peripheral ulcer. She also feels the product has a benefit for any patient who has rosacea. “All of my patients have come back and said that they have found this to be very effective in making their eyes more comfortable and increasing their contact lens wear time,” said Dr. Sindt. Others have even resumed contact lens wear. She also pointed out that her patients are experiencing reductions in both itching and dry eye symptoms. Art Epstein, OD, FAAO, who practices in Phoenix, has had success with Avenova and now keeps the product in stock so that his patients have immediate access to it. Previously, his patients were using baby shampoos that were stripping a lot of the oils from the skin, which was a significant concern with MGD and blepharitis. “In some cases of lid disease,” he said, “the Staph bacteria produce lipases, which lead to saponification, and you end up with only ‘soaps’ on the lids, which is why patients have burning eyes.” Dr. Epstein said the hypochlorous acid cleanser works effectively without the detergent action and also counteracts some of the toxins that are produced by bacteria. Therefore, his patients get a lot of relief using the product. He noted that treatments for eyelid disease have not changed for a number of years and that the hypochlorous acid cleanser is really an ideal solution for a very prevalent problem. The development of bacterial resistance with the cleanser is not a Continued on next page. AVENOVA NEWS | RX LID CLEANSER AIDS BLEPHARITIS, MGD Rx Lid Cleanser Aids Blepharitis, MGD
  • 10. 10 Rx Lid Cleanser Aids Blepharitis, MGD 9/29/2014 | Optometry Times concern. His patients appreciate Avenova’s results, not only in terms of the efficacy and gentleness of the product, but also in their overall cosmetic appearance. Use in therapeutic regimens The 0.01 percent hypochlorous acid eyelid cleanser has a useful place in the therapeutic armamentarium for any instance where enhanced lid hygiene is needed: • Blepharitis for better management of signs and symptoms • Dry eye (MGD) to decrease irritation associated with dry eye • Preoperative/perioperative care for cataract, refractive, glaucoma surgery, and retinal surgery • After contact lens wear • Other ocular irritation How to create a dry eye center Recolonization of bacteria can be a chronic problem. For example, women routinely reuse eye makeup and inoculate themselves with bacteria during each application. Rubbing the eyes with the fingers can also be a source of bacterial and allergen contamination. The cleanser can be used in place of baby shampoo and other commercially available lid scrubs. Data to be presented this fall demonstrates that the cleanser produces a faster bacterial kill than other agents that are currently available. The product can be used in conjunction with other products. It provides a complimentary mechanism of action to add to the treatment of Demodex sp. It helps to prevent secondary bacterial colonization and reduce the inflammatory response caused by exotoxins from the mites. Dr. Epstein recommends the cleanser for lid hygiene as a stand-alone agent. He also has his patients use it in conjunction with other agents, such as antibiotics, for more severe cases of MGD and blepharitis. In some cases, the patients were able to discontinue their antibiotic therapy after using the cleanser. He also recommends Avenova for his patients who have undergone LipiFlow therapy. Dr. Sindt often recommends a natural oil product, such as coconut oil, to soften the tissue around the eye and help with cleaning the flaking debris. She then has her patients use Avenova to remove the bacterial bioburden effectively on the eyelid surface. The cleanser formulation does not contain other buffers, preservatives, or surfactants and is therefore gentle enough for everyday use. This contributes to one of the side-benefits of the product that patients feel more comfortable in their contact lenses or are often even able to resume wearing their lenses. *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015. REFERENCES 1. Rosenfield M. Computer vision syndrome: a review of ocular causes and potential treatments. Ophthalmic Physiol Opt. 2011 Sep;31:502-15. 2. Bentivoglio AR, Bressman SB, Cassetta E, et al. Analysis of blink rate patterns in normal subjects. Mov Disord. 1997 Nov;12(6):1028-34. 3. Ellwein LB, Urato CJ. Use of eye care and associated charges among the Medicare population: 1991-1998. Arch Ophthalmol. 2002 Jun;120(6):804-11. 4. Lindsley K, Matsumura S, Hatef E, et al. Interventions for chronic blepharitis. Cochrane Database Syst Rev. 2012 May 16;5:CD005556. 5. Asbell PA. Increasing importance of dry eye syndrome and the ideal artificial tear: consensus views from a roundtable discussion. Curr Med Res Opin. 2006 Nov;22(11):2149-57. 6. American Academy of Ophthalmology. Preferred Practice Pattern Guidelines. Dry eye syndrome. San Francisco, CA: American Academy of Ophthalmology; 2011. 7. Albietz JM. Dry eye: an update on clinical diagnosis, management and promising new treatments. Clin Exp Optom. 2001 Jan-Feb;84(1):4-18. 8. Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs and symptoms in patients with dry eye disease. Cornea. 2004 Nov;23(8):762-70. 9. Nichols KK, Foulks GN, Bron AJ, et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9. 10. Lindstrom RL, Donnenfeld ED, Foulks GN, et al. Blepharitis 2010. Update on research and management. Ophthal Times. 2010; 1-15. 11. Foulks GN. Enhancing our knowledge of blepharitis. Ocul Surf. 2009 Apr;7(2 Suppl):S15-6. 12. Lemp MA, Nichols KK. Blepharitis in the United States 2009: a survey-based perspective on prevalence and treatment. Ocul Surf. 2009;7(2 Suppl):S1-14. 13. Rumpakis JMP. New data on contact lens dropouts: an international perspective. Rev Optom. 2010;1:1-4. 14. Crew JR, Varilla R, Rocas TAI, et al. Treatment of acute necrotizing fasciitis using negative pressure wound therapy and adjunctive neutrophase irrigation under the foam. Wounds. 2013; 25:272-7. 15. Albric M, McCarthy CA, Hurst JK. Biological reactivity of hypochlorous acid: implications for microbicidal mechanisms of leukocyte myeloperoxidase. Proc Natl Acad Sci USA. 1981 Jan;78(1):210-4. 16. Wang L, Bassiri M, Najafi R, et al. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr;6:e5. 17. Kim HJ, Lee JG, Kang JW, et al. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. 18. Harrison-Balestra C, Cazzaniga AL, Davis SC, et al. A wound-isolated Pseudomonas aeruginosa grows a biofilm in vitro within 10 hours and is visualized by light microscopy. Dermatol Surg. 2003 Jun;29(6):631-5. 19. LeChevallier MW, Cawthon CD, Lee RG. Inactivation of biofilm bacteria. Appl Environ Microbiol. 1988 Oct;54(10):2492-9. 20. Robson MC, Payne WG, Ko F, et al. Hypochlorous Acid as a Potential Wound Care Agent: Part II. Stabilized Hypochlorous Acid: Its Role in Decreasing Tissue Bacterial Bioburden and Overcoming the Inhibition of Infection on Wound Healing. J Burns Wounds. 2007 Apr;6:e6. 21. Szczotka-Flynn L, Lass JH, Sethi A, et al. Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5421-30. AVENOVA NEWS | RX LID CLEANSER AIDS BLEPHARITIS, MGD
  • 11. 11AVENOVA NEWS | NEW BLEPHARITIS TREATMENTS A decade ago, we looked at the latest treatment options for blepharitis. It’s high time we eye them up again. We’ve been authoring the “Therapeutic Review” column for 10 years now. In one of our very first entries, “Put a Lid on Blepharitis,” we discussed the importance of differentiating the various forms of blepharitis and creating an individualized treatment strategy for each patient.1 Like many procedures and protocols in eye care, blepharitis management has evolved during the last decade. It’s time to revisit this topic and examine some of the newest, most promising treatment options. Calling your bleph A recently published survey of eye care providers suggested that some form of blepharitis is present in nearly half of our patients––whether or not they are symptomatic upon presentation.2 This means that every practicing optometrist likely sees this condition in one form or another on a daily basis. Unfortunately, our traditional therapies for blepharitis have relied heavily on ongoing patient-administered intervention and compliance. Newer treatment modalities not only provide more targeted therapy, but also offer the promise of rapid recovery for most individuals. Scrub-a-dub-dub Lid scrubs have long been the mainstay of blepharitis management. Detergent-based products, such as OcuSoft Lid Scrub or TheraTears SteriLid, applied to the lids and lashes help to remove accumulated debris and excessive oils from the eyelid margins. Also, these products diminish bacterial reservoirs, combating the overgrowth of flora that incites and perpetuates staphylococcal blepharitis. BlephEx As mentioned previously, the effectiveness of home-based lid scrubs is directly contingent upon the patient’s level of dexterity, thoroughness and overall compliance. Recently, however, RySurg introduced BlephEx—a handheld device that allows physicians to perform an in-office “deep cleansing” of the lid margins. James Rynerson, MD, principal developer of BlephEx and CEO of Rysurg, LLC, refers to this new treatment as “microblepharoexfoliation.” BlephEx is indicated for removal of lid debris and microbial biofilm, which Dr. Rynerson touts as the primary source of all ocular surface inflammation. The device incorporates a disposable, high-speed, rotating microsponge designed to clean both the anterior and posterior lid margins, making it appropriate for all forms of blepharitis. In practice, we use BlephEx in cases of staphylococcal and seborrheic blepharitis, demodicosis and even MGD as a form of debridement scaling for the meibomian glands.3 Be aware that there is no ICD-9 code associated with BlephEx at this time, and thus no insurance coverage. Patients’ out-of-pocket costs for the procedure typically range from $150 to $200, or more in some cases. Like dental cleanings, this procedure is recommended semi-annually—or even more frequently in severe cases. Dropping Acid (on the Lids) While surfactant cleaners certainly have a role in blepharitis management, they can be messy, irritating and unpleasant for some patients. Moreover, if conventional cleansers fail to control bacterial replication adequately, practitioners may need to resort to more aggressive therapies, such as topical antibiotics or antibiotic- steroid combinations. Continued on next page. By Alan G. Kabat, OD, and Joseph W. Sowka, OD | 10/15/2014 | Review of Optometry This 80-year-old woman presented with severe blepharitis secondary to Demodex folliculorum infestation (top). Following microblepharoexfoliation, she exhibited improvement (bottom). New Blepharitis Treatments
  • 12. 12AVENOVA NEWS | NEW BLEPHARITIS TREATMENTS New Blepharitis Treatments By Alan G. Kabat, OD, and Joseph W. Sowka, OD | 10/15/2014 | Review of Optometry Avenova* Recently, NovaBay Pharmaceuticals introduced this novel antiseptic agent specifically indicated for the treatment of blepharitis. The company describes it as “the first FDA 510K-cleared prescription product to clean the lids and lashes, removing the debris and microorganisms that cause chronic inflammation.” Avenova is a stabilized solution comprised of 0.01% hypochlorous acid (HOCl), a microbicidal component of the innate immune system.4 HOCl is naturally produced by neutrophils in response to pathogenic organisms, and can kill bacteria, block bacterial-derived toxins and blunt the effects of human cell- derived pro-inflammatory mediators.5,6 The product is packaged in a glass bottle with a pump sprayer, and can be applied to the lids via a cotton ball, cosmetic pad or gauze. While there aren’t yet any specific clinical studies demonstrating its efficacy, colleagues employing the product in their blepharitis treatment regimen have noted substantial improvement in both signs and symptoms when applied BID for just 10 days.7 Avenova is sold exclusively through physicians’ offices and online by the manufacturer. It retails for approximately $30 for a 40mL bottle. Demodex Demolition During the time that we’ve been writing the “Therapeutic Review” column, Demodex has gone from being a vague, rarely-recognized and poorly managed lid pathogen to one of the most common causes of blepharitis that we see in clinical practice. We’ve known for some time that it is resistant to most conventional lid cleansers and antimicrobial agents, but is highly responsive to tea tree oil.8 Cliradex A recently published study identified the most potent demodicidal element in tea tree oil to be terpinen-4-ol, or 4-terpineol.9 This chemical compound is the active ingredient in Bio-Tissue’s Cliradex lid wipes. The company suggests that it is “a natural, preservative-free lid, lash and facial cleanser that helps manage symptoms associated with blepharitis, meibomian gland dysfunction, rosacea, dry eye, Demodex, chalazia and other lid margin diseases.” Since its release last September, Cliradex has become a mainstay treatment for our patients with demodicosis and ocular rosacea (which also seems to have a probable association with Demodex).10 Also, it has eliminated the need to obtain pharmaceutically compounded agents of varying concentrations for Demodex infestation. We typically prescribe Cliradex BID for 10 days, and then QD at bedtime for another 10 days in cases of Demodex blepharitis, ideally after performing microblepharo- exfoliation. The product is sold exclusively through physicians’ offices and online, and retails for about $40 per carton, which contains 24 lid wipes. Bio-Tissue also recently introduced the Cliradex Complete kit, which contains one carton of Cliradex lid wipes, a tube of Cliradex Advanced Care gel (a slightly more concentrated version of 4-terpineol for in-office application to the lids and lashes), a dual-sided applicator and instructions for the doctor and patient. This kit is designed for use by eye care clinicians only, and so individual providers typically will determine patient cost as a combination in-office/at-home therapeutic procedure. Time marches on––but fortunately, each passing year brings a greater understanding of the physical maladies that plague our patients, as well as provides us with new tools to control their deleterious effects. Even something as seemingly common as blepharitis warrants consideration and intervention to help improve our patients’ vision and overall quality of life. We would also like to express our gratitude to the editors who have worked with us on this column throughout the past 10 years, including Jen Kirby, Leah Addis and especially our current editor, Mike Hoster. Dr. Kabat is a paid consultant to Bio-Tissue and Alcon Laboratories. Neither he nor Dr. Sowka has any direct financial interest in the products mentioned. *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015. REFERENCES 1. Kabat AG, Sowka JS. Put a lid on blepharitis. Rev Optom. 2004 Nov; 141(11):123-4. 2. Lemp MA, Nichols KK. Blepharitis in the United States 2009: A survey-based perspective on prevalence and treatment. Ocul Surf. 2009 Apr;7(2 Suppl):S1-S14. 3. Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. 4. Wang L, Bassiri M, Najafi R, et al. Hypochlorous acid as a potential wound care agent: part I. Stabilized hypochlorous acid: a component of the inorganic armamentarium of innate immunity. J Burns Wounds. 2007 Apr 11;6:e5. 5. Gray MJ, Wholey WY, Jakob U. Bacterial responses to reactive chlorine species. Annu Rev Microbiol. 2013;67:141-60. 6. Ono T, Yamashita K, Murayama T, Sato T. Microbicidal effect of weak acid hypochlorous solution on various microorganisms. Biocontrol Sci. 2012;17(3):129-33. 7. Krader CG. Ophthalmology Times. Hypochlorous acid lid cleanser provides novel advantages. Available at: http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/news/hypochlorous-acid-lid- cleanser-provides-novel-advantages. Accessed September 14, 2014. 8. Gao YY, Di Pascuale MA, Li W, et al. In vitro and in vivo killing of ocular Demodex by tea tree oil. Br J Ophthalmol. 2005 Nov;89(11):1468-73. 9. Tighe S, Gao YY, Tseng SC. Terpinen-4-ol is the most active ingredient of tea tree oil to kill Demodex mites. Transl Vis Sci Technol. 2013 Nov;2(7):2. 10. Holmes AD. Potential role of microorganisms in the pathogenesis of rosacea. J Am Acad Dermatol. 2013 Dec;69(6):1025-32.
  • 13. 13 New Eye Treatment Is “One of the Best Tools I’ve Found,” Patient Reports 10/30/2014 | Eye Institute An informal survey of doctors and patients finds that NovaBay Pharmaceuticals’ Avenova is improving the quality of patients’ lives all across the U.S. The Eye Institute, located in Marin County, California, announced today that an informal nationwide survey of eye doctors and patients shows success with the use of a recently launched product, Avenova*, as part of the treatment for Evaporative Dry Eye Syndrome associated with Blepharitis and Meibomian Gland Dysfunction. The condition is the result of over- colonization of Staph bacteria, resulting in inflammation of eye lids and blockage of meibomian glands that help lubricate the eye surface. “We’re finding this innovative product has had significant impact in helping many patients,” said Kathryn Najafi-Tagol, MD, Founder and Medical Director of the Eye Institute. One grateful patient in the survey is Ramsey Flynn of Towson, Maryland. Blepharitis “has impaired my life for over 20 years,” Flynn reported. But recently, his eye doctor, renowned eye surgeon Sheri Rowen, MD, introduced him to what he described as “a remarkably simple prescription called Avenova. It’s a gentle solution that I can spray onto a cotton ball and wipe across my closed eyelids.” The product finally brought him relief. “It’s one of the best tools I’ve found in my fight against the unruly beast of blepharitis,” he reported. “Much recommended!” Dr. Rowen commented, “Blepharitis is an often very uncomfortable and can be a chronic condition where Staphylcocci bacteria grow on eyelids, causing swelling, redness, inflammation, irritation, a crusty build-up. It often causes enough inflammation to block the Meibomian glands that provide lubrication to the surface of cornea. This is a widespread problem affecting an estimated 23 million sufferers across the United States.” Avenova is made by NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY) and has been cleared by the FDA as a skin and wound cleanser. It has in-vitro broad antimicrobial activity because of NovaBay’s proprietary ingredient, Neutrox™, which mimics the substance used by white blood cells as their first line of defense against bacteria and other microbial invaders. Lab tests also show Neutrox not only kills bacteria, it also neutralizes the bacterial toxins that contribute to Blepharitis and associated dry eye syndrome. John Moore, a retired professional from Walnut Creek, CA, is another satisfied patient. He suffered from Blepharitis for over ten years. Nothing brought him relief—until he was prescribed Avenova. “I am so happy with the results,” he reported. Similarly, other Blepharitis patients— and their doctors—say that Avenova has finally brought them relief. The survey also asked ophthalmologists and optometrists for their experiences with Avenova. A sampling of responses: — “I have to say that it really is amazing and patients love it,” reported Scott Kamena, O.D., at Murrieta Optometry in Livermore, CA. — “Under the microscope on a wet prep done by two of our interested O.D.’s who specialize in Ocular Surface Disease, NovaBay Avenova appears to kill Demodex,” said Dick Lindstrom, M.D., founder and attending surgeon of Minnesota Eye Consultants as well as Adjunct Clinical Professor Emeritus at the Department of Ophthalmology, University of Minnesota and Chair, ASCRS Foundation. — “NovaBay Avenova offers a long term solution and is a safe option for the management of over colonized lid flora,” wrote Eric Donnenfeld, M.D., F.A.C.S. National Medical Director of TLC Laser Eye Centers, based in Connecticut, New York and New Jersey. — “We have had very nice results,” wrote S. Barry Eiden, O.D., F.A.A.O., President and Medical Director of North Suburban Vision Consultant, Ltd. and assistant clinical professor at the University of Illinois, Chicago. — “I’ve been using it for a few months and I am impressed with it. Patients seem to like it and appear improved on it,” wrote Steven G. Safran, M.D., PA, an ophthalmologist in Lawrenceville, NJ. — “i-Lid has been a huge improvement over soap-based lid scrubs,” reported Susan J. Gromacki, O.D., M.S., F.A.A.O. of Washington Eye Physicians & Surgeons in Chevy Chase, MD. Kathyrn Najafi-Tagol, MD (Ophthalmologist) The Eye Institute 415-444-0300 AVENOVA NEWS | NEW EYE TREATMENT IS “ONE OF THE BEST TOOLS I’VE FOUND,” PATIENT REPORTS *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.
  • 14. 14 11/2014 | Primary Care Optometry News Clinicians can look beyond eye drops for options to treat dry eye, blepharitis and meibomian gland dysfunction Schaeffer recommends the compresses to other doctors, with one note of caution. “It’s important to keep a clean environment, and heating these masks in the office in a microwave that’s used for food is not good medical technique,” he explained. “I highly suggest buying a small microwave just for the compresses.” Cliradex lid hygiene kit The Cliradex Complete Advanced Lid Hygiene Kit (Bio-Tissue), which contains a gel as well as cleansing wipes, “represents a significant advantage over other commercially produced blepharitis kits as well as the ‘homemade’ versions involving diluted concentrations of raw tea tree oil,” according to Scott G. Hauswirth, OD, FAAO, a PCON Editorial Board member. He noted that he uses it for in-office treatments of aggressive blepharitis, especially types involving Demodex mites. “It contains the active ingredient in tea tree oil, 4-terpineol, in a topical cream,” Hauswirth explained. “There is a double-sided applicator included, as well as a box of Cliradex wipes.” Hauswirth prefers using the Cliradex kit for multiple reasons, he told PCON. “First, studies have shown that 4-terpineol is more effective with a faster kill rate than raw tea tree oil,” he said. “Second, the cream-like consistency of the product makes for safer application to the lids and lash base, so there is less likely a chance of over-application and resultant oil draining into the eye. Third, the thicker consistency means longer residence time on the surface with potentially greater potency against the offending organism.” Patients are complaining less of discomfort and irritation after using the product, Hauswirth has found. “From an integration standpoint, it is an easy adjustment to this kit from the product we were using prior,” he said. “I generally do two applications of the 4-terpineol cream at the visit, then give the patient a carton of Cliradex cleansing wipes to use at home on the eyelids.” Hauswirth said the Cliradex wipes are sold in his optical, but that he uses the Cliradex kit as an in-office application. Avenova Katherine Mastrota, MS, OD, FAAO, has found Avenova* (NovaBay), a prescription solution, to be “an excellent adjunct to familiar commercially available and well established products. “Avenova is a lid hygiene maintenance product,” she explained. “It is a bottled, liquid solution containing Neutrox, which is pure hypochlorous acid. Clinically, hypochlorous acid is generated in activated neutrophils and contributes to the destruction of bacteria. The solution is non-sensitizing and oxidizes quickly after application, so it is ideal for de-bulking microbial load and the associated biofilms from the eyelash base and lid margins.” Mastrota told PCON that she has investigated the product on numerous types of patients, including those with dry eye complicated with meibomian gland dysfunction and blepharitis, those with atopic dermatitis, ocular rosacea or mild blepharoconjunctivitis as well as contact lens wearers. For those in whom she also prescribes hot compress therapy, she suggests they use the Avenova first. “It makes sense to me to de-bulk the lids both mechanically and therapeutically before a compress process,” Mastrota said. “I generally show patients the spray- delivered product in the office, describe how to use it and send them with a prescription for their pharmacist to supply it,” she said. “I explain to them that although the product has a chlorine-like scent, it will not sting as they might expect. Mastrota told PCON that NovaBay has early evidence that Avenova is acaracidal. From white paper studies, however, they have in vitro evidence that the hypochlorous acid solution Continued on next page. AVENOVA NEWS | ALTERNATIVE PRODUCTS AVAILABLE TO COMBAT OCULAR SURFACE DISEASE Alternative Products Available to Combat Ocular Surface Disease
  • 15. 15 Alternative Products Available to Combat Ocular Surface Disease 11/2014 | Primary Care Optometry News AVENOVA NEWS | ALTERNATIVE PRODUCTS AVAILABLE TO COMBAT OCULAR SURFACE DISEASE has significant activity against a host of microbes, both gram-positive and gram-negative. “It is presumed from these studies that iLid Cleanser would be efficacious against Bacillus oleronius, a Demodex- associated bacteria,” she said. “The bacillus may incite pathology as opposed to the mite.” The only suggestion she has in terms of product improvement is the addition of an adjunct surfactant product. “As Avenova contains only Neutrox and saline, it has no surfactant properties,” she said. “It will not remove most eye makeup, nor is it designed to do so. Akin to the dermatology and cosmetology practice of ‘cleaner and toner,’ Avenova, in my mind, is best used after makeup remover with a doctor-recommended surfactant product. Going forward, I would like to see a paired surfactant product as well as application pads added to Avenova.”– by Chelsea Frajerman FOR MORE INFORMATION: Scott G. Hauswirth, OD, FAAO, is a Primary Care Optometry News Editorial Board member. He is a member of the Minnesota Eye Consultants clinical staff, leads the optometric student externship program at Minnesota Eye Consultants and is adjunct faculty at the Southern California College of Optometry as well as the Illinois College of Optometry. He can be reached at sghauswirth@mneye.com. Katherine Mastrota, MS, OD, FAAO, is the center director of Omni Eye Surgery in New York. She can be reached at katherinemastrota@msn.com. Jack Schaeffer, OD, specializes in general optometry. He is the president and CEO of Schaeffer Eye Center, which has 16 locations in Alabama. He can be reached at drschaeffer@schaeffereyecenter.com. Steve Silberberg, OD, practices in New Jersey. He can be reached at spacedoc@alum.mit.edu. Disclosures: Hauswirth is a consultant to Bio-Tissue. Mastrota is on the advisory boards of Bio-Tissue and NovaBay. Schaeffer has attended an advisory board meeting for Bruder. Silberberg is a consultant for Bausch + Lomb and CooperVision. *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015. REFERENCE McMahon F, et al. Invest Ophthalmol Vis Sci. 2014; doi: 10.1167/iovs.14-15018. Accessed October 20, 2014.
  • 16. 16 New Study Shows Effectiveness of Avenova 11/20/2014 | VMail Technology AVENOVA NEWS | NEW STUDY SHOWS EFFECTIVENESS OF AVENOVA Product: Avenova Top Line: The Eye Institute, located in Marin County, Calif., recently announced that an informal nationwide survey of eye doctors and patients shows success with the use of a recently launched product, Avenova from NovaBay Pharmaceuticals, to treat Evaporative Dry Eye Syndrome associated with Blepharitis and Meibomian Gland Dysfunction. The condition is the result of over- colonization of Staph bacteria, resulting in inflammation of eye lids and blockage of meibomian glands that help lubricate the eye surface. “We’re finding this innovative product has had significant impact in helping many patients,” said Kathryn Najafi-Tagol, MD, founder and medical director of the Eye Institute. Close Up: Avenova has broad in-vitro antimicrobial activity and has been cleared by the FDA as a skin and wound cleanser. Avenova* maintains its antimicrobial activity by the use of NovaBay’s proprietary ingredient, Neutrox, which contains the same active ingredient used by white blood cells as their first line of defense against bacteria and other microbial invaders. Lab tests show Neutrox not only kills bacteria, it also neutralizes the bacterial toxins that contribute to blepharitis and another condition called dry eye syndrome. Vital Stats: The active ingredient in Avenova is a proprietary pure and stable form of hypochlorous acid or HOCI. HOCI is a bacterial component of the innate immune system. Incorporation into a commercial product required Dr. Najafi-Tagol to engineer a formulation that would maintain the stability of the acid and avoid other impurities. Results from pharmaceutical laboratory studies conducted by NovaBay Pharmaceuticals in coordination with Dr. Najafi-Tagol’s Eye Institute evaluating the stabilized hypochlorous acid proved that it has fast-acting, broad-spectrum activity against microorganisms found in the external ocular flora plus the ability to disrupt biofilm that harbors bacteria. Dr. Najafi-Tagol’s testing also established that Avenova is non-toxic to human tissues, non-irritating, and hypoallergenic. Avenova is available by prescription only. It comes in a 40ml glass bottle with a fine mist spray pump included. The product has recently been added to the Vision Source Network, and is also available through local pharmacies and major retail chains across the U.S., such as Wal-Mart, Costco, CVS and Target, through a distribution agreement between NovaBay Pharmaceuticals and McKesson Corp. Click here to see a video about Avenova. www.avenova.com (800) 890-0329 *The name of “i-Lid Cleanser” has been changed to “Avenova” in this article to reflect the rebranding that occurred in January 2015.