[May 03, 2016] |
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Clinical Data Presented at ARVO Showing NovaBay's Avenova Reduces Bacteria on Ocular Skin Surface by More than 90%
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.
About Avenova
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 chroniceye 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.
Forward-Looking Statements
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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NovaBay Contacts For NovaBay Avenova
purchasing information, please contact: Email
us Call us: 1-800-890-0329 www.Avenova.com
View source version on businesswire.com: http://www.businesswire.com/news/home/20160503005359/en/
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