1. Avenova
(formerly i-Lid™
Cleanser)
A NEW DIMENSION IN LID AND LASH HYGIENE
Ron Najafi, Ph.D.
Chairman & CEO
NovaBay Pharmaceuticals, Inc.
email: Rnajafi@NovaBay.com
(New York Stock Exchange: NBY)
2. The San Francisco Bay Area
Home to NovaBay Pharmaceuticals
(A view from our facilities)
3. NovaBay Pharmaceuticals
Employees: 28, founded in 2000 by Ron Najafi, Ph.D. (chemist)
NovaBay Dedicated Sales Force: 39, all across the US
Location: Emeryville, CA
Capital Structure: Public Company, listed on NYSE: NBY
Focus: Non-Antibiotic Antimicrobials
Marketed products (Neutrox platform)
– Avenova: (formerly i-Lid™ Cleanser ) . Lid & Lash Hygiene, Blepharitis,
MGD and Dry Eye.
– NeutroPhase: Diabetic Ulcer, Venous and Pressure Ulcers, including NF)
– CelleRx: Burn associated with Post Laser Resurfacing
Pre-Market Products (Aganocide platform)
– Bladder Irrigation Solution for patients with Spinal Cord Injury and recurrent
blockage and encrustation
– Skin Infection (Impetigo and Acne)
Global Partnerships: PBE (in the US), IHT (USA), Galderma (France), Virbac
(France), Pioneer Pharma (China and Southeast Asia), Shin Poong (Korea), Biopharm
(North African and Middle East)
8. Expressing the Meibomian Gland
Shows Dysfunction present
Tooth Paste
like
consistency is
bad
Doctor is
pressing
against lower
eye lid
9. Blepharitis / Meibomian Gland Dysfunction/
Associated Dry Eye / Pre-Operative Lid
Hygiene
Chronic lid & lash hygiene
- 24 million blepharitis patients
- 6.5 million MGD dry eye patients
- 3 million cataract patients
- 1.5 million refractive surgery patients
10. Avenova (formerly i-Lid™
Cleanser)
for Conditions of the Lids and Lashes
Proprietary Technology
– Neutrox : NovaBay Proprietary Pure 0.01% Pure hypochlorous
solution in saline
– No bleach impurities, which is present in Dakin and Dakin-like
solutions
– No resistance expected based on novel mechanism of action
Significant Market / Poorly Served
– Eyelid hygiene therapy, part of the treatment for blepharitis
– Currently marketed products have little to no benefit
– 4% of 18 – 22 year olds
– 71% of 65+ year olds
11. Why Control of Lid Flora Matters?
Blepharitis
MGD with secondary staph
overpopulation
Pre-op surgical prophylaxis
– Refractive
– Cataract
– Retinal
Contact lens wear
18. Neutrox™
(NovaBay’s Proprietary Pure Hypochlorous Acid)
Excellent
activity
against a
broad range
of pathogens
Fast acting
onset of
activity
Effective
against
pathogens
commonly
found on the
lids & lashes
19. 20
Avenova™ demonstrated excellent activity in solution
compared with the market leading lid and lash cleanser*
Organism S. aureus MRSA S. epidermidis S. haemolyticus P. acnes
NovaBay
Avenova®
< 1 minute < 1 minute < 1 minute < 1 minute < 1 minute
OcuSoft® Lid
Scrub Foam
> 30 minute > 30 minute > 30 minute > 30 minute > 30 minute
20. Avenova has higher Therapeutic
Index than Betadine
• Fast acting
onset of
microbial
activity
• Extremely
low toxicity
levels
• 1,000 times
less toxicity
than
Betadine®
21
Agent Tested Hypochlorous Acid
.01%
Betadine® Surgical
Scrub (Povidone-
iodine, 7.5%)
Nontoxic
Dilution
1:10 1:10,000
Time to 4 log10
kill
<1 minute >24 hours
Tested Against S. aureus ATCC 33591
*Antimicrobial Activity Comparison of Pure HypoChlorous Acid (0.01) with other Wound and Skin Cleansers at Non-Toxic
Concentrations, Russell Hoon, Suriani Abdul Rani, Ramin Najafi, Lu Wang, Dmitri Debabov; SAWC Spring 2013 and WHD
2013
21. Research on Biofilms
22
• Hypothesis is that
bacterial biofilm
plays a significant
role in delaying
wound healing
(Mertz – Wounds – May
2003)
A scanning electron micrograph of a porcine wound surface
with Staphylococcus aureus biofilm (6000X)
22. 23
NovaBay Avenova® has Potent Anti-biofilm
Activity Compared to Saline
• In vitro Biofilm of P. fluorescens breaks up upon
introduction of Avenova®
SALINE (control) NovaBay Avenova
23. Hypochlorous Acid
Hypochlorous acid
(HOCL) released from
neutrophil cells
Part of body’s immune
response
Kills microorganisms
Neutralizes toxins
released from pathogens
and inflammatory
mediators
– helps suppress the body’s
inflammatory response
24
neutrophil
cell
HOCL
27. Representation of the Mechanism of
Action of Hypochlorous .01% in In-Vitro
Models
Kills bacteria
Blocks
bacteria
produced
toxins
Blocks
human cell
produced
pro-
inflammatory
mediators
28. Dx of DES and Blepharitis:c/o irritation, pain; used Maxitrol drops and
ointment for 2 wks + warm compress and eye scrub with Baby Shampoo. Was
shown how to clean his lids and lashes in the office with Saline.
Still returned 2 wks later with similar symptoms. Maxitrol was d/c’d and
Avenova given. After 2 wks RTC with improved symptoms and improved
clinically on Exam.
After Use of Baby Shampoo After use of Avenova
29. Typical Blepharitis Case
Vision:
– OD 20/30
– OS 20/20-
TAP: OD 21 OS 23
Exam:
– Blepharitis
– Debris on lashes
– Conjunctival
hyperemia
30. • From end of 2008 until end of 2012
• Patient was seen 25 times
• Between visits he would call and get Rx for Ab.
• Received courses of:
• Bacitracin, neomycin, polymyxin, tobradex,
maxitrol, zylet, oral doxy, used Ocusoft.
• Patient developed skin ulcer from Ocusoft use
• 10% of patients who use these over the counter
eye lid scrubs will develop contact dermatitis
• Eczema type reaction due to their detergent
based components
Patient Case History: Chronic Blepharitis
42. Patients with acute or early stage meibomian gland
disease have a frothy tear film, or bubbles, which is
evident here at the lid margin.
43.
44.
45. Staph aureus is a consistent Lipase producer
Breaking down natural lipids (triglycerides) from
Meibomian Gland
Bacteria Lipase activity is responsible for the
breakdown of lipid to fatty acids
– [Invest. Ophthalmol. Vis. Sci.April 1986 vol. 27 no. 4 486-491]
Assuming Lipase causes saponification of lipid
and conversion to fatty acid and soap. Can
Avenova breakdown Lipase and prevent
saponification (soap making)
50. To Open an account contact:
NovaBay by calling:
1-800-890-0329
Retail to patients: $30
If used according to instructions:
1st bottle will last 2 weeks
(2X per day application)
2nd bottle will last 1 month
(1X per day application)
