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Medical Devices / Regulatory Affairs / Submissions and Approvals

Oculus’ Microcyn Scar Management Hydrogel Receives 510(K) Nod

Dec. 6, 2013

Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products.

The agency clearance is based on results from a double-blind, multi-center, randomized study that showed that Microcyn gel more effectively reduced scar vascularity, height, thickness, pliability, itching, pain and color using the Vancouver Scar Scale.

The gel, which is applied directly to scars, requires no dressing unless there is a risk of smearing on clothing or furniture, said Oculus spokesperson Dan McFadden. If it’s a recent wound, however, patients can apply the gel and dress it with gauze.

Oculus plans to make the gel available in the U.S. through partner Quinnova Pharmaceuticals in the first half of 2014. Plans are also afoot to market the drug in Mexico, China, Singapore, Malaysia and India, followed by other Latin American and Middle East countries next year. — Lena Freund

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