NovaBay Pharmaceuticals to Present Features and Benefits of the intelli-Case at FDA Public Advisory Meeting
March 09 2017 - 6:50AM
Business Wire
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
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.
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 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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NovaBay ContactsFor NovaBay
Avenova purchasing information, please contact:Email usCall us:
1-800-890-0329www.Avenova.comorFrom the
CompanyThomas J. PaulsonChief Financial
Officer510-899-8809Contact TomorInvestor
Contact:LHAJody Cain310-691-7100Jcain@lhai.com
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