FDA Approves Restylane Silk

The U.S. Food and Drug Administration (FDA) has issued marketing clearance for Restylane Silk Injectable Gel with 0.3% Lidocaine (Valeant Pharmaceuticals), indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.

Restylane Silk is a clear hyaluronic acid injectable gel, which contains 0.3% lidocaine. The clinical study, conducted to evaluate the safety and effectiveness of injections to enhance lip fullness and to improve the wrinkles around the lips, included 221 mostly female subjects. Ninety-eight percent of subjects reported improvement in their lip fullness 14 days after injection and 76% of the subjects still had lip improvement six months after their injection. The majority of adverse events were mild in intensity and the most common symptoms were lip swelling, contusion, and lip pain. The incidence of adverse event decreased significantly after the second treatment.

Restylane Silk is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies; patients with a history of allergies to gram positive bacterial proteins; patients with bleeding disorders; and for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation. Restylane Silk should not be used in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine.

"We are pleased to have received marketing clearance from the FDA for Restylane Silk so quickly after the approval of Jublia," said J. Michael Pearson, chairman and CEO of Valeant. "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."