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Avenova
(formerly i-Lid™
Cleanser)
A NEW DIMENSION IN LID AND LASH HYGIENE
Ron Najafi, Ph.D.
Chairman & CEO
NovaBay Pharma...
The San Francisco Bay Area
Home to NovaBay Pharmaceuticals
(A view from our facilities)
NovaBay Pharmaceuticals
Employees: 28, founded in 2000 by Ron Najafi, Ph.D. (chemist)
NovaBay Dedicated Sales Force: 39, a...
“The Most Under-
recognized
The Most
Underappreciated
The Most Undertreated
disease
in Ophthalmic Care”
Anatomy of Eye and Lid and
Meibomian Gland
Blepharitis: Infection and
Inflammation of EyeLid
Blepharitis Causes:
Meibomian Gland Dysfunction (MGD).
Gland Oil Keep
the water from
evaporating &
preventing Dry
Eye.
Expressing the Meibomian Gland
Shows Dysfunction present
Tooth Paste
like
consistency is
bad
Doctor is
pressing
against lo...
Blepharitis / Meibomian Gland Dysfunction/
Associated Dry Eye / Pre-Operative Lid
Hygiene
Chronic lid & lash hygiene
 - 2...
Avenova (formerly i-Lid™
Cleanser)
for Conditions of the Lids and Lashes
Proprietary Technology
– Neutrox : NovaBay Propri...
Why Control of Lid Flora Matters?
Blepharitis
MGD with secondary staph
overpopulation
Pre-op surgical prophylaxis
– Refrac...
Does not
generate
Resistance
Mechanical
Debridement
Anti-Toxin
Anti-biofilm
Activity
Bacterial
Removal✓
✓
✓
✓
✓
Blephariti...
Does not
generate
Resistance
Mechanical
Debridement
Anti-Toxin
Anti-biofilm
Activity
Bacterial
Removal✓
✓
✓
✓
✓
Omega 3
Fatty Acid
Omega 3 Fatty Acid,
Rich in EPA & DHA
Eicosapentaenoic Acid (EPA), 20 carbons and 5 double bonds.
Docos...
Why Neutrox™ ?
PURE Hypochlorous Acid [ HOCl ]
Cl
O
H
Neutrox™
(NovaBay’s Proprietary Pure Hypochlorous Acid)
Excellent
activity
against a
broad range
of pathogens
Fast acting
...
20
Avenova™ demonstrated excellent activity in solution
compared with the market leading lid and lash cleanser*
Organism S...
Avenova has higher Therapeutic
Index than Betadine
• Fast acting
onset of
microbial
activity
• Extremely
low toxicity
leve...
Research on Biofilms
22
• Hypothesis is that
bacterial biofilm
plays a significant
role in delaying
wound healing
(Mertz –...
23
NovaBay Avenova® has Potent Anti-biofilm
Activity Compared to Saline
• In vitro Biofilm of P. fluorescens breaks up upo...
Hypochlorous Acid
Hypochlorous acid
(HOCL) released from
neutrophil cells
Part of body’s immune
response
Kills microorgani...
Representation of bacteria-produced
toxins which attack human cells
26
Representation of human cell response
to bacteria-produced toxins
27
Representation of the Mechanism of
Action of Hypochlorous .01% in In-Vitro
Models
Kills bacteria
Blocks
bacteria
produced
...
Dx of DES and Blepharitis:c/o irritation, pain; used Maxitrol drops and
ointment for 2 wks + warm compress and eye scrub w...
Typical Blepharitis Case
Vision:
– OD 20/30
– OS 20/20-
TAP: OD 21 OS 23
Exam:
– Blepharitis
– Debris on lashes
– Conjunct...
• From end of 2008 until end of 2012
• Patient was seen 25 times
• Between visits he would call and get Rx for Ab.
• Recei...
32
Avenova™
(formerly i-Lid Cleanser)
33
with
Neutrox
as preservative
Avenova™
(formerly i-Lid Cleanser)
Severe Ocular Surface Disease
with Demodex
After 3 wks of use of Avenova™
Patients with acute or early stage meibomian gland
disease have a frothy tear film, or bubbles, which is
evident here at t...
Staph aureus is a consistent Lipase producer
Breaking down natural lipids (triglycerides) from
Meibomian Gland
Bacteria Li...
Lipase
Methyl Resorufin
Lipase Viability Assay
Lipase Substrate
Method used:
1) We treated Lipase with the test article
2)...
Avenova™(formerly i-Lid Cleanser)
inactivates Bacterial Lipase
Chronic use of antibiotic
will result in antibiotic
resistant strains
Product Comparison (Ingredients)
50
OCuSoft SteriLid Oasis
Lid
and
Lash
LIDCLE
NZ
VisiClean
se
Eye
Scrub
Ingredient
s
Hypo...
To Open an account contact:
NovaBay by calling:
1-800-890-0329
Retail to patients: $30
If used according to instructions:
...
Thank you!
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
Avenova January 2015 Final
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Avenova January 2015 Final

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Avenova January 2015 Final

  1. 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. 2. The San Francisco Bay Area Home to NovaBay Pharmaceuticals (A view from our facilities)
  3. 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)
  4. 4. “The Most Under- recognized The Most Underappreciated The Most Undertreated disease in Ophthalmic Care”
  5. 5. Anatomy of Eye and Lid and Meibomian Gland
  6. 6. Blepharitis: Infection and Inflammation of EyeLid
  7. 7. Blepharitis Causes: Meibomian Gland Dysfunction (MGD). Gland Oil Keep the water from evaporating & preventing Dry Eye.
  8. 8. Expressing the Meibomian Gland Shows Dysfunction present Tooth Paste like consistency is bad Doctor is pressing against lower eye lid
  9. 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. 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. 11. Why Control of Lid Flora Matters? Blepharitis MGD with secondary staph overpopulation Pre-op surgical prophylaxis – Refractive – Cataract – Retinal Contact lens wear
  12. 12. Does not generate Resistance Mechanical Debridement Anti-Toxin Anti-biofilm Activity Bacterial Removal✓ ✓ ✓ ✓ ✓ Blepharitis MGD Multifactorial Chronic Disease Affects Quality of life
  13. 13. Does not generate Resistance Mechanical Debridement Anti-Toxin Anti-biofilm Activity Bacterial Removal✓ ✓ ✓ ✓ ✓
  14. 14. Omega 3 Fatty Acid Omega 3 Fatty Acid, Rich in EPA & DHA Eicosapentaenoic Acid (EPA), 20 carbons and 5 double bonds. Docosahexaenoic Acid (DHA), 22 carbons and 6 double bonds.
  15. 15. Why Neutrox™ ? PURE Hypochlorous Acid [ HOCl ] Cl O H
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. 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)
  20. 20. 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
  21. 21. 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
  22. 22. Representation of bacteria-produced toxins which attack human cells 26
  23. 23. Representation of human cell response to bacteria-produced toxins 27
  24. 24. 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
  25. 25. 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
  26. 26. Typical Blepharitis Case Vision: – OD 20/30 – OS 20/20- TAP: OD 21 OS 23 Exam: – Blepharitis – Debris on lashes – Conjunctival hyperemia
  27. 27. • 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
  28. 28. 32 Avenova™ (formerly i-Lid Cleanser)
  29. 29. 33 with Neutrox as preservative Avenova™ (formerly i-Lid Cleanser)
  30. 30. Severe Ocular Surface Disease with Demodex
  31. 31. After 3 wks of use of Avenova™
  32. 32. Patients with acute or early stage meibomian gland disease have a frothy tear film, or bubbles, which is evident here at the lid margin.
  33. 33. 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)
  34. 34. Lipase Methyl Resorufin Lipase Viability Assay Lipase Substrate Method used: 1) We treated Lipase with the test article 2) We looked for Lipase viability next
  35. 35. Avenova™(formerly i-Lid Cleanser) inactivates Bacterial Lipase
  36. 36. Chronic use of antibiotic will result in antibiotic resistant strains
  37. 37. Product Comparison (Ingredients) 50 OCuSoft SteriLid Oasis Lid and Lash LIDCLE NZ VisiClean se Eye Scrub Ingredient s Hypochlorous acid, saline Water , PEG- 80 Sorbitan Laurate , Sodium Tricedeth Sulfate , PEG-150 Distearate , Disodium Lauroamphod iacetate , Cocamidopro pyl Hydroxysultai ne , Sodium Laureth-13 Carboxylate , Sodium Chloride , Quaternium- 15 Water , PEG 80 , Sorbitan Laurate , Sodium Trideceth Sulfate , Cocamidopropyl Betaine , Sodium Lauroamphoace tate , PEG 150 Distearate , Sodium Laureth 13 Carboxylate , Linalool Oil , Hepes Acetate , Sodium Perborate Monohydrate , Panthenol , Allantoin (Comfrey Root) , Sodium Chloride , Tea Tree (Melaleuca Alternifolia) Oil , Water, Poloxamer, Polyethylen e,Glycol,Bo rate,Hyalur onan,Methy lparaben, Carbopol 940 non-foaming pH balanced formulation of non-ionic surfactant in purified water Water, Cocamidopropyl Betaine, PEG- 80 Sorbitan, Laurate, Sodium Trideceth Sulfate, PEG- 150 Distearate, Aloe, Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower, Extract, Cucumis Sativus (Cucumber) Fruit Extract, Althaea Officinalis, Root Extract, Avena Sativa (Oat) Kernel Extract, Tetrasodium Water USP (Purified), PEG 200 Hydrogenated Glyceryl Palmate, Disodium Laureth Sulfosuccinat e, Cocoamidopr opylamine Oxide, PEG 80 Glyceryl Cocoate, Benzyl Alcohol, Edetate Disodium
  38. 38. 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)
  39. 39. Thank you!

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