Oculus Innovative Sciences Surges 26%: Here's Why

Shares of Oculus Innovative Sciences, Inc. OCLS surged higher by more than 26 percent on Wednesday after the company announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration for its Microcyn®-based Lasercyn™ Gel.

Oculus Innovative is a specialty pharmaceutical company that develops and markets therapies for the treatment of dermatological conditions and advanced tissue care. As noted by the FDA, A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

Following the clearance from the FDA, the company will began marketing Lasercyn through its own dermatology sales team as soon as this summer.

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."

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: NewsFDAFDA ClearanceLasercyn GelMichael GoldOculus Innovative Scinces
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!