Oculus Innovative Sciences has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Microcyn scar management HydroGel, intended to manage old and new hypertrophic and keloid scarring resulting from burns, general surgical procedures and trauma wounds.
Quinnova Pharmaceuticals, the US dermatology partner of Oculus Innovative Sciences, plans to commercialize the Microcyn scar management HydroGel in the first half of 2014.
Oculus Innovative Sciences is also working with its international distributors and partners to commercialize the new product across the globe, including Latin American partner, More Pharma, with expected commercialization in Mexico in 2014.
The company anticipates launching the new scar product in China, Singapore, Malaysia and India after April 2014. The company will also introduce the product in Kuwait, UAE, Jordan and Iraq after April 2014.
Oculus Innovative Sciences has conducted a double-blind, randomized clinical study to demonstrate equivalency to a predicate device in scar management as part of the FDA 510(k) review process.
The multi-center study that enrolled 40-patients at four US sites was conducted over 16 weeks, ending March 2013.
Investigators assessed the qualified scar using the Vancouver Scar Scale, which measures scar vascularity, height/thickness, pliability and pigmentation. Additionally, pain and itch symptoms were also evaluated.
Oculus Innovative Sciences CEO Jim Schutz noted the company is pleased to receive this scar management 510(k) clearance, which is the eighth FDA approval or clearance for the company’s Microcyn-based products to date.
"We believe that Quinnova’s dermatology sales and marketing expertise, and our strong supporting clinical data for this new product, is a winning combination for doctors and their patients. We look forward to sharing this new FDA clearance with our international partners to make this great product available outside the United States as soon as we clear international regulatory hurdles," Schutz added.