Oculus hydrogel treatment receives FDA 510(k) clearance for scarring

The FDA has given 510(k) clearance for a hydrogel treatment of hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds, Oculus Innovative Sciences announced.

The FDA 510(k) review process involved a double blind, multicenter randomized clinical study conducted by Oculus to demonstrate the equivalency of Microcyn Scar Management HydroGel to a predicate device in scar management, according to a press release. Forty patients with linear or widespread hypertrophic or keloid scars were studied at four US sites for 16 weeks in the study earlier this year. The Vancouver Scar Scale (VSS) was used to evaluate scars, ranging in age from 3 months to 1 year, by assessing vascularity, height/thickness, pliability and pigmentation. Patients evaluated pain and itch symptoms.

In the Microcyn HydroGel and the active control groups, the VSS total score improved consistently at each visit. On Day 56, the end of treatment, the mean VSS total score improvement was –2.10 in the Microcyn group compared with –1.28 in the control group. On day 112, the end of study visit, the Microcyn group had a mean VSS total score of –2.7 compared with –1.83 in the control group.

Greater reductions in individual signs and symptoms, including itch and pain, also were reported in the Microcyn treatment group.

Microcyn Scar Management HydroGel will be marketed nationally by Quinnova Pharmaceuticals in the first half of 2014, according to the release.

“We have known for years that there has been practitioner demand for an efficacious and safe prescription treatment to manage hypertrophic and keloid scarring,” Jeffrey Day, Quinnova Pharmaceuticals CEO, said in the release. “The data from the FDA-required study certainly validates the product’s potential in the dermatology space.”