The FDA committee will discuss and make recommendations regarding the potential risks of misuse of peroxide-based contact lens products
NovaBay’s FDA-cleared intelli-Case offers an innovative solution
EMERYVILLE, Calif. (March 9, 2017) – NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a pharmaceutical company focusing on commercializing its Avenova® lid and lash hygiene in the domestic eye care market, today announced that it has been invited to present information about its innovative intelli-Case™ for use with hydrogen peroxide to safely disinfect contact lenses at the U.S. Food and Drug Administration’s (FDA) Ophthalmic Devices Panel Advisory Meeting on March 17, 2017 in Gaithersburg, MD. The FDA meeting will specifically focus on labeling and packaging of hydrogen peroxide disinfection systems for contact lenses.
“Up to six million contact lens wearers currently use peroxide disinfecting systems,” said David Stroman, Ph.D., NovaBay’s Senior Vice President for Ophthalmic Product Development. “Hydrogen peroxide is considered the gold standard for disinfecting contact lens; however, these peroxide systems have several issues. Current cases used in disinfecting lenses contain a catalyst that neutralizes the hydrogen peroxide over time. Further, there is no assurance that the peroxide has been sufficiently neutralized for the lens to be safely inserted onto the eyes, with even a small amount of remaining hydrogen peroxide causing burning and stinging.”
At the FDA meeting, Dr. Stroman and Glenn Moro, NovaBay’s Vice President of Marketing, will describe the features and benefits of the intelli-Case, which offers solutions to these problems. During the advisory meeting, FDA officials will seek input from a range of constituencies, members of industry, and the general public.
Based upon its use of a sophisticated microprocessor embedded in the cap of the case to analyze the rate of neutralization of hydrogen peroxide, and its innovative design and engineering, the intelli-Case has been patented through the USPTO. The case communicates to the lens wearer through a series of LED lights (red, yellow, and green). The intelli-Case blinks red to indicate that a problem with the peroxide solution or neutralization process has been detected, yellow while the disinfection process is underway and green only after the process has been successfully completed and the lenses are safe to place on the eyes.
“The intelli-Case was specifically designed to significantly reduce the problems and uncertainties that consumers are having disinfecting their lenses with peroxide systems,” added Dr. Stroman.
“We are seeking a commercial partner with an established position in the ophthalmic market to provide the funding to move this program forward and commercialization of the innovative, FDA-cleared intelli-Case, while we focus our resources on the commercialization of Avenova,” said Mark Sieczkarek, CEO of NovaBay Pharmaceuticals.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
Avenova is formulated with Neutrox®, which is cleared by the U.S. Food and Drug Administration (FDA) as a 510(k) medical device. Neutrox is NovaBay’s commercial name for its proprietary pure hypochlorous acid. Data from a multicenter clinical study show that Avenova reduced bacterial load, the underlying cause of blepharitis, on ocular skin surface by more than 90%. Laboratory tests show that hypochlorous acid has potent antimicrobial activity in solution yet is non-toxic to mammalian cells and also neutralizes bacterial toxins. Avenova is marketed to optometrists and ophthalmologists throughout the U.S. by NovaBay’s direct salesforce. It is accessible from more than 90% of retail pharmacies in the U.S. through agreements with McKesson Corporation, Cardinal Health and AmerisourceBergen.
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 possible commercialization of the intelli-Case and the financial impact that may have on our Company. 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 the Company’s ability to obtain the necessary partnerships to commercialize the intelli-Case. 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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Thomas J. Paulson
Chief Financial Officer