Oculus Innovative Gets FDA Clearance For Microcyn Scar Management HydroGel

(RTTNews) - Oculus Innovative Sciences Inc. (OCLS) announced Wednesday that it has received a new 510(k) clearance from the U.S. Food and Drug Administration or FDA for the company's new Microcyn Scar Management HydroGel. The Rx product, under the supervision of a healthcare professional, is intended for the management of old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds.

Oculus U.S. dermatology partner, Quinnova Pharmaceuticals, intends to commercialize the product in the first half of 2014.

In addition to U.S. commercialization, Oculus said it is working with its international distributors and partners to bring this new scar product to patients throughout the globe, including Latin American partner, More Pharma, with anticipated commercialization in Mexico in 2014.

The company noted that further product launches should follow shortly after in other Latin American countries as regulatory approvals are secured. In the Asian countries of China, Singapore, Malaysia and India, product launches are anticipated sometime after April 2014. Similarly, the scar product will be introduced in Kuwait, UAE, Jordan and Iraq in the same time frame.