FDA clears Restylane Silk hyaluronic acid gel

The Food and Drug Administration has granted marketing clearance for Restylane Silk (Valeant), an injectable gel containing 0.3 percent lidocaine, for lip augmentation and perioral rhytids in patients age 21 and older.

The injectable gel was investigated in a clinical study to determine its safety and efficacy in submucosal implantation for lip augmentation and dermal implantation for the treatment of perioral rhytids, according to a news release. The study included 221 patients; 98 percent of those treated reported an improvement in lip fullness at 14 days postprocedure, and 76 percent noted lip improvement six months after the treatment.

Adverse events were reportedly mild and included contusions, lip swelling and lip pain. Incidence of adverse events decreased “significantly” after the second treatment, according to Valeant.

“We are pleased to have received marketing clearance from the FDA for Restylane Silk so quickly after the approval of Jublia,” J. Michael Pearson, Valeant chairman and chief executive officer, said in the news release. “Our R&D team is hitting on all cylinders and demonstrating that Valeant has a successful, output-focused R&D model that concentrates on areas of expertise where we are confident that our investments will pay off.”