Oculus Innovative Sciences, Inc.: Oculus Innovative Sciences Receives European
CE Mark for Use of Microcyn(R) in the Topical Treatment of Mild to Moderate
PETALUMA, Calif., Feb. 4, 2014 (GLOBE NEWSWIRE) -- Oculus Innovative
Sciences, Inc. (Nasdaq:OCLS), a global healthcare company that designs,
manufactures and markets prescription and non-prescription products in 31
countries, today announced receipt of the European CE Mark for the
Microcyn®-based GramaDerm® Solution and GramaDerm® Hydrogel. Both products
are intended for use in the topical treatment of mild to moderate acne and
are designed to complement other acne treatments.
The new CE Mark was issued by the European notified body, EMKI. The CE Mark
is an indication that a medical device complies with the essential
requirements of the medical devices directive (93/42/EEC) and that the
device has been subjected to conformity assessment procedures. Receipt of
the CE Mark will allow Oculus to market and sell the Microcyn-based
GramaDerm Solution and GramaDerm Hydrogel in EU member countries that have
adopted the medical devices directive without being subject to additional
national regulations with regard to demonstration of performance and safety,
although certain EU member countries may request or require additional
performance and/or safety data from time to time, on a case-by case basis.
"Securing the CE Mark for our acne products is just the beginning of Oculus'
multiple product development initiatives in our continuing European growth
strategy," said Bruce Thornton, Oculus executive vice president of
international operations. "With CE Mark approval, our EU partnering process
has picked up considerably. In addition, we anticipate announcing regulatory
approvals and commercialization ofother Microcyn-based products, including
those for new oral and advanced wound careindications, over the next few
While a new drug application for Microcyn acne formulation has not yet been
filed in the United States, a number of U.S. dermatologists have been using
the Microcyn-based atopic dermatitis hydrogel since its introduction in
early 2012.As permitted by law, some of these physicians have clinically
evaluated the impact of Microcyn in the management of a wide range of
dermatological afflictions including acne.
"We've been successfully using a Microcyn-based hydrogel in my clinic for
two years," said Dr. Rebecca Smith, a dermatologistat Fort Mill Dermatology
in South Carolina. "I have seen promising secondary benefits of Microcyn in
thereduction of inflammation and severity of acne outbreaks. Inlight of
the European directive to reduce the use of topical antibiotics to
minimizeresistance concerns, European dermatologists will be delighted with
the news regardingGramaDerm's approval. We look forward to a similar
product approval in the US in the future."
In a study published in the Journal of Dermatological Treatment (April 2009)
by Tirado-Sánchez, A. "Efficacy and Tolerance of superoxidized solution in
the treatment of mild to moderate inflammatory acne," the Microcyn
Technology, upon which the GramaDerm HydroGel is based, outperformed benzyl
peroxide (a standard ingredient in many acne treatments) in the reduction of
inflammatory lesions as a monotherapy associated with the treatment of
acne.At the end of the 12-week study period, the percentage reduction in
the number of inflammatory lesions from the initial baseline was 65% in the
Microcyn arm versus 54% in the benzyl peroxide arm.The Microcyn product
outperformed the benzyl peroxide, the general standard of care, but the
difference was not statistically significant.However, the Microcyn
technology has not, thus far, demonstrated any bacterial resistance and it
tends to have an impeccable safety profile.
Global Acne Market
In a 2010 report issued by Research and Markets, it was indicated that the
global acne market was worth $2.8 billion in 2009 and is estimated to reach
revenues of $3.02 billion by 2016 at a Compound Annual Growth Rate (CAGR) of
0.7%. The current market has several products which act on acne by targeting
different etiologic factors involved in the development of acne. The acne
therapeutics market is witnessing a shift towards combination products,
using two or more effective acne treatments at one time.
The acne market is primarily genericised and is moderately served by the
currently marketed drugs. The majority of the pipeline products of large
pharmaceutical companies also consist of combination products with very few
first-in-class molecules. With emerging me-too combination products in the
pipeline that are not significantly different from the current
monotherapies, the acne market awaits a blockbuster advance. Increases in
the population in general and an increase in the prescription rate are
estimated to sustain the acne market in the future.
About Oculus Innovative Sciences
Oculus Innovative Science is a global healthcare company that designs,
manufactures and marketsprescription and non-prescription products in 31
countries. The company's products are used to treat patients in
surgical/advanced wound management, dermatology, women's health and animal
health; addressing the unmet medical needs of these markets-while raising
the standard ofpatient care and lowering overall healthcare costs. The
company's headquarters are in Petaluma, California, with manufacturing
operations in the United States and Latin America. More information can be
Except for historical information herein,matters set forth in this press
release are forward-looking within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995,
including statements about the commercial and technology progress and
futurefinancial performance of Oculus Innovative Sciences, Inc. and its
subsidiaries (the "Company"). These forward-looking statements are
identified by the use of words such as "anticipates,""believes," "expects,"
and "intends,"among others. Forward-looking statements in this press
release are subject to certain risks and uncertainties inherent in the
Company's business that could cause actual results to vary,
includingsuchrisks thatregulatory clinical and guideline developments may
change,scientific data may not be sufficient to meet regulatory standards
or receipt of required regulatory clearances or approvals,clinical results
may not be replicated in actual patient settings,protection offered bythe
Company'spatents and patent applications may be challenged, invalidated or
circumvented by its competitors,the available market
fortheCompany'sproducts will not be as large as expected,the
Company'sproducts will not be able to penetrate one or more targeted
markets,revenues will not be sufficient to fund further development and
clinical studies, the Company may not meet itsfuture capital needs, and its
ability to obtain additional funding, as well as uncertainties relative to
varying product formulations and a multitude of diverse regulatory and
marketing requirements in different countries and municipalities, and other
risks detailed from time to time in the Company's filings with the
Securities and Exchange Commission including the annual report on Form 10-K
for theyear ended March 31, 2013. Oculus Innovative Sciences disclaims any
obligation to update these forward-looking statements except as required by
Oculus and Microcyn® Technology are trademarks or registered trademarks of
Oculus Innovative Sciences, Inc. All other trademarks and service marks are
the property of their respective owners.
Media and Investor Contact:
Oculus Innovative Sciences, Inc.
VP of Public and Investor Relations
This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf
of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for
the content, accuracy and originality of the information contained therein.
Source: Oculus Innovative Sciences, Inc. via Globenewswire
Press spacebar to pause and continue. Press esc to stop.