Oculus Innovative Sciences Receives U.S. FDA Approval for Lasercyn™ for Use Following Laser Procedures, Microdermabrasions ...
April 20 2016 - 4:05AM
Oculus Innovative Sciences, Inc. (NASDAQ: OCLS, warrants OCLSW), a
specialty pharmaceutical company that develops and
markets solutions for the treatment of dermatological
conditions and advanced tissue care, today announced it has
received a new 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for the company’s new Microcyn®-based
Lasercyn™ Gel. Under the supervision of a healthcare
professional, Lasercyn Gel is intended for the management of
post-non-ablative laser therapy procedures, post-microdermabrasion
therapy and following superficial chemical peels. Lasercyn may also
be used to relieve itch and pain from minor skin irritations,
lacerations, abrasions and minor burns.
Dr. Michael Gold, board-certified dermatologist and cosmetic
surgeon, and founder of Gold Skin Care Center, Advanced Aesthetics
Medical Spa, The Laser & Rejuvenation Center, and Tennessee
Clinical Research Center, all located in Nashville, Tennessee,
commented, “Lasercyn is a promising new tool for all aesthetic
dermatologists who are looking to better manage post-laser itch and
pain associated with laser skin resurfacing, along with enhanced
healing. In our clinical testing of Lasercyn to date, we have seen
dramatically improved outcomes with quicker healing times and less
patient discomfort when Lasercyn is added to the post-procedure
management protocol.”
Oculus will begin marketing Lasercyn via its own U.S.
dermatology sales team beginning in the summer of 2016.
About Laser Skin ResurfacingAccording to the
Clinical, Cosmetic and Investigational Dermatology Journal, medical
and aesthetic skin procedures have seen a steady surge within the
last decade, and a higher demand for skin rejuvenation practices.
In 2013 in the United States, dermatologic surgeons performed over
9.5 million treatments, an almost 22% increase from the previous
year, with a rising number of treatments involving skin resurfacing
in the areas of laser/light/energy-based procedures (2.25 million),
chemical peels (1.1 million), and microdermabrasion (974,000).
Laser skin resurfacing, also known as a laser peel, laser
vaporization and lasabrasion, can reduce facial wrinkles, scars and
blemishes. Newer laser technologies provide surgeons with a new
level of control in laser surfacing, permitting extreme precision,
especially in delicate areas. The laser beam used in laser
resurfacing will remove outer layer of skin, called the epidermis.
It simultaneously heats the underlying skin, called the dermis.
This action works to stimulate growth of new collagen fibers. As
the treated area heals, the new skin that forms is smoother and
firmer.
Common side effects include redness of the skin, swelling of the
treated area, itch, pain and moderate irritation similar to the
feeling produced by a mild sunburn.
About Oculus Innovative Sciences, Inc.Oculus
Innovative Sciences is a specialty pharmaceutical company that
develops and markets solutions for the treatment of
dermatological conditions and advanced tissue care. The company’s
products, which are sold throughout the United States and
internationally, have improved outcomes for more than five million
patients globally by reducing infections, itch, pain, scarring
and harmful inflammatory responses. The company's headquarters are
in Petaluma, California, with manufacturing operations in the
United States and Latin America. European marketing and sales
are headquartered in Roermond, Netherlands. More information can be
found at www.oculusis.com.
Forward-Looking StatementsExcept 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 “marketing” and “looking,” 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 common stock and warrants may be
delisted from NASDAQ, 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, the Company
may not be able 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 its annual report on Form 10-K for
the year ended March 30, 2015. The Company disclaims any
obligation to update these forward-looking statements, except as
required by law.
Oculus®, Microcyn® Technology and Lasercyn™ 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.
Dan McFadden
VP of Public and Investor Relations
(425) 753-2105
dmcfadden@oculusis.com
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