DGAP-News: Oculus Innovative Sciences, Inc. /
Oculus Innovative Sciences Receives European CE Mark for Use of
Microcyn(R) in the Topical Treatment of Mild to Moderate Acne
04.02.2014 / 14:08
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PETALUMA, Calif., 2014-02-04 14:08 CET (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(r)-based GramaDerm(r) Solution and GramaDerm(r) 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 of other Microcyn-based products, including
those for new oral and advanced wound care indications, over the next few
quarters.'
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 dermatologist at Fort Mill Dermatology in
South Carolina. 'I have seen promising secondary benefits of Microcyn in the
reduction of inflammation and severity of acne outbreaks. In light of the
European directive to reduce the use of topical antibiotics to minimize
resistance concerns, European dermatologists will be delighted with the news
regarding GramaDerm'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-Sanchez, 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 markets prescription 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 of patient 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 found at
www.oculusis.com.
Forward-Looking Statements
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 future financial 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, including such risks that regulatory 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 by the Company's patents and patent applications may be challenged,
invalidated or circumvented by its competitors, the available market for the
Company's products will not be as large as expected, the Company's products
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 its future 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 the year ended March 31, 2013. Oculus Innovative
Sciences disclaims any obligation to update these forward-looking statements
except as required by law.
Oculus and Microcyn(r) Technology are trademarks or registered trademarks of
Oculus Innovative Sciences, Inc. All other trademarks and service marks are the
property of their respective owners.
CONTACT: Media and Investor Contact:
Oculus Innovative Sciences, Inc.
Dan McFadden
VP of Public and Investor Relations
(425) 753-2105
News Source: NASDAQ OMX
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Language: English
Company: Oculus Innovative Sciences, Inc.
United States
ISIN: US67575P1084
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250964 04.02.2014
DGAP-News: Oculus Innovative Sciences Receives European CE Mark for Use of Microcyn(R) in the Topical Treatment of Mild to Moderate Acne
| Source: EQS Group AG