Avenova is the Only Commercial Product Clinically Validated in a Multicenter Study to Substantially Reduce Bacteria that Can Cause Blepharitis
NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY) a biopharmaceutical company focusing on commercializing its Avenova® Lid and Lash Hygiene product for the domestic eye care market, announces the presentation of clinical data demonstrating that Avenova reduced the bacterial load on the ocular skin surface by more than 90% in 20 minutes without affecting the diversity in the type of bacteria remaining. Results of the Avenova study were discussed in an oral presentation by NovaBay’s Senior Vice President of Ophthalmology Development David Stroman, Ph.D. at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Seattle.
Glenn Moro, NovaBay’s Vice President of Sales & Marketing, commented, “In vitro and non-clinical studies have shown that in solution the bacteria and other microorganism that are a common underlying cause of chronic conditions such as blepharitis are killed. In fact, many patients suffering from the itchiness, inflammation and irritation associated with blepharitis and dry eye syndrome are reporting relief of symptoms in as little as two weeks with soothing Avenova used twice-daily.
“That said, many ophthalmologists and optometrists are looking for clinical validation before prescribing Avenova to their patients,” explained Mr. Moro. “We now have that validation, giving us a clear advantage in a very large and underserved market.”
“This study validates my clinical impressions of Avenova,” said Dr. Arthur B. Epstein, Director of Clinical Research and head of the Dry Eye – Ocular Surface Disease Center at Phoenix Eye Care. “It is like a getting a haircut. You remove excess hair but the number of hair follicles doesn’t change. It’s the same thing with Avenova. Avenova removes excess bacteria but doesn’t change the mix of bacterial strain diversity.”
“These clinical data show that Avenova with NovaBay’s proprietary pure hypochlorous acid reduced the bacterial load and thus decreased the potentially clinically significant bacterial overpopulation by more than 90%, without altering the diversity of bacteria on the ocular skin surface in any significant way,” said Dr. Stroman. “This lowering of the bacterial load was particularly noteworthy for all staphylococci, including S. epidermidis, the most frequently recovered species. It is exciting to unveil these positive study results to the many attendees at the ARVO conference.”
In the multicenter study, microbiological specimens were collected from the lower lid of 71 eyes from 36 subjects immediately before and 20 minutes after application of Avenova. The specimens were processed by a clinical microbiology laboratory for quantitative recovery of aerobic and anaerobic bacteria. Before treatment with Avenova, 194 unique bacteria strains belonging to 26 different species were recovered. At 20 minutes following treatment, 138 unique bacterial strains belonging to 26 different species were recovered, indicating no significant alteration of the bacteria diversity on the ocular surface.
Avenova is formulated with Neutrox™, NovaBay’s proprietary pure hypochlorous acid without any sodium hypochlorite impurities. Hypochlorous acid is naturally produced by white blood cells to fight microbial invaders.
Avenova is well suited for daily use by the approximately 30 million Americans who suffer from chronic eye conditions like blepharitis, meibomian gland dysfunction and associated dry eye syndrome. Avenova is also being used as a pre-surgical cleansing and preparation for Lasik and cataract procedures, for retinal injections and in managing and reducing contact lens intolerance. NovaBay estimates the U.S. market for Avenova at approximately 41 million patients.
NovaBay is marketing Avenova as a prescription medical device, regulated under the 510(k) process. Avenova for eyelid and lash hygiene falls under the more general intended use as a skin/wound cleanser. The initial wound care product, NeutroPhase®, was cleared by the FDA “for use under the supervision of healthcare professionals for cleansing and removal of foreign material, including microorganisms and debris from wounds, and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I to IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, and grafted and donor sites.”
About ARVO 2016 Annual Meeting
The Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) is the largest gathering of eye and vision researchers in the world, attracting more than 11,000 attendees from more than 75 countries.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics
NovaBay Pharmaceuticals is a biopharmaceutical company focusing on the commercialization of prescription Avenova® Lid and Lash Hygiene for the eye care market. Avenova is formulated with Neutrox™, which is cleared by the FDA as a 510(k) medical device. Neutrox is NovaBay’s pure hypochlorous acid. Avenova is marketed to optometrists and ophthalmologists throughout the U.S. by NovaBay’s direct medical salesforce. It is accessible from more than 90% of retail pharmacies in the U.S. through agreements with McKesson Corporation, Cardinal Health and AmeriSource Bergen.
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the anticipated market acceptance of our products, future sales of our products, and the Company’s expected future financial results. Forward looking statements in this release can be identified by the words “expect,” “believe,” and “approximately,” or variations of these words. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in manufacturing, distributing, and selling the Company’s products, unexpected adverse side effects or inadequate therapeutic efficacy of our product, the uncertainty of patent protection for the Company’s intellectual property, and the Company’s ability to obtain additional financing as necessary. Other risks relating to NovaBay’s business, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
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At the Company
Thomas J. Paulson
Chief Financial Officer