Valeant Pharmaceuticals Receives FDA Clearance For Restylane Silk

The FDA issued marketing clearance for Valeant Pharmaceuticals International, Inc.'s Restylane Silk Injectable Gel with 0.3% Lidocaine 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 crystal clear injectable gel composed of hyaluronic acid, a natural substance that already exists in the body. Restylane Silk is non-animal based and free from animal protein. Allergy pretesting is not necessary.

A clinical study was conducted with Restylane Silk to evaluate the safety and effectiveness of injections to enhance lip fullness and to improve the wrinkles around the lips. The study included 221 mostly female subjects and evaluated subjects with light and dark skin. Subjects with very dark skin were not studied.

Ninety-eight percent (98%) of subjects reported improvement in their lip fullness 14 days after injection and 76% of the subjects still had lip improvement 6 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; for implantation in anatomical spaces other than the dermis or submucosal implantation for lip augmentation and 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 chief executive officer. "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."

Complete information on Restylane® Silk, can be found at www.valeant.com.