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Oculus Innovative Sciences Receives New FDA 510(k) Clearance For Microcyn-Based Dermatology HydroGel For Management Of Atopic Dermatitis, Radiation Dermatitis And Other Skin Dermatoses

Oculus Innovative Sciences, Inc. (NASDAQ:OCLS), a commercial healthcare company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, announced today it had received a new FDA 510(k) clearance for its uniquely formulated Microcyn-based Epicyn™ HydroGel. Under the supervision of a healthcare professional, it is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis and radiation dermatitis. Epicyn HydroGel may also be used to relieve the pain of first- and second-degree burns and can help to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. The hydrogel is a shelf-stable hypochlorous acid formulation based on the company’s proprietary Microcyn Technology platform.

“Our newly approved dermatology indication opens two interesting new markets to Oculus atopic dermatitis, which afflicts 15 million U.S. patients, and radiation dermatitis, with over one million U.S. patients. The use of the proprietary Microcyn Technology for these challenging skin afflictions is truly a unique approach and adds both depth and breadth to Oculus’ dermatology product portfolio,” said Hoji Alimi, founder and CEO of Oculus. “And in line with our business strategy, we plan to partner this new indication at the earliest for faster commercialization.”

About Atopic Dermatitis

More than 15 million patients have symptoms of atopic dermatitis, characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20 percent of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor.

In a 2009 GlobalData study, it was estimated the global atopic dermatitis therapeutics market delivered revenues of $643 million in 2009. It is expected to grow to $810 million at a Compound Annual Growth Rate (CAGR) of 3.4% by 2016. This growth is primarily attributed to an increase in competition among existing products and the presence of a strong pipeline with more emerging therapies. Globally, the United States remains the largest market for atopic dermatitis therapeutics, and generated revenue of $402 million in 2009. It is forecast to grow at a CAGR of 3.8% over the next seven years to reach $582 million by 2016.

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