Oculus Innovative Sciences, Inc. was greeted with good news, when the U.S. Food and Drug Administration (FDA) cleared its new Microcyn Scar Management HydroGel. Oculus shares soared 103.4% following the news and ended at $4.74 on Dec 4. The stock also touched a 52-week high of $7.21 during the course of the trading session on that day.
Oculus received a 510(k) clearance from the U.S. regulatory body for Microcyn Scar Management HydroGel for the management of old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds. The product is approved for the indication under a healthcare professional’s supervision. The FDA clearance of Microcyn Scar Management HydroGel was based on positive results from a double-blind, multi-center, randomized clinical study (n=40).
Oculus expects its U.S. partner, Quinnova Pharmaceuticals, to launch Microcyn Scar Management HydroGel in the first half of 2014. Oculus is also working with other partners to make the product available around the globe.
The company expects Microcyn Scar Management HydroGel to be available in Mexico in 2014 through its Latin American partner, More Pharma. Oculus also expects the scar product to be available in countries like China, Singapore, Malaysia, India, Kuwait, UAE, Jordan and Iraq after Apr 2014.
We are encouraged by the U.S. approval of scar product. We expect investor focus to stay on the product’s launch across the globe in the coming quarters.
Oculus presently carries a Zacks Rank #4 (Sell). Some better ranked stocks include Actelion Ltd. , Lannett Company, Inc. (LCI - Free Report) and AMAG Pharmaceuticals, Inc. (AMAG - Free Report) . While Actelion and Lannett hold a Zacks Rank #1 (Strong Buy), AMAG carries a Zacks Rank #2 (Buy).