FDA Clears Scar Management Gel from Oculus and Quinnova

December 4, 2013

Oculus Innovative Sciences, Inc. has received a new 510(k) clearance from the FDA 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. Oculus U.S. dermatology partner, Quinnova Pharmaceuticals, intends to commercialize the product in the first half of 2014.

In a 16-week study to demonstrate equivalency to a predicate device in scar management, patients with linear or widespread hypertrophic or keloid scars consistently were treated with Microcyn Scar Management HydroGel. Investigators evaluated the qualified scar using the Vancouver Scar Scale, which assesses scar vascularity, height/thickness, pliability and pigmentation. In addition, pain and itch symptoms were evaluated by the subjects. In both the Microcyn HydroGel and the active control groups, the VSS total score improved consistently at each of the visits. At the end of treatment visit (Day 56), the mean VSS total score improvement from baseline was -2.10 in the Microcyn group, versus -1.28 in the control group. At the end of the study visit (Day 112), the mean VSS total score improvement was -2.70 in the Microcyn group and -1.83 in the control group. While both groups improved, the reductions were greater in both instances for the Microcyn group.

Individual signs and symptoms scores were evaluated throughout the study, which included improvement in itch and pain. The reductions from baseline in the mean individual signs and symptoms scores were greater in the Microcyn group.

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