The U.S. Food and Drug Administration issued marketing clearance to Valeant Pharmaceuticals for Restylane Silk injectable gel with 0.3% lidocaine, the company announced in a press release.
Restylane Silk injectable gel is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients older than 21 years.
“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 CEO, said in the 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.”
In a clinical study, 98% of 221 patients saw improvement in lip fullness 14 days after injection; lip improvement was maintained 6 months after the injection in 76% of patients, according to the release.
Most adverse events were mild; the most common symptoms were lip swelling, confusion and lip pain. Adverse events subsided considerably after the second treatment, the release said.
Restylane Silk is contraindicated for patients with severe allergies, anaphylaxis or multiple severe allergies, those with allergies to gram-positive bacterial proteins and bleeding disorders; and for implantation in anatomic areas aside from the dermis or submucosal implantation for lip augmentation. It should not be used in patients with known hypersensitivity to local anesthetics such as lidocaine, the release said.