New Restylane Formula Approved

Valeant Pharmaceuticals has received FDA clearance for a new Restylane formulation to smooth lines around the mouth and enhance lips.

Restylane Silk is a clear injectable gel composed of a non-animal-based formulation of hyaluronic acid and 0.3% lidocaine – added to reduce the discomfort associated with the treatment.

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

“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.”

A clinical study found that 98%, of 221 mostly female participants, noticed improvement in their lip fullness 14 days after injection and 76% had lip improvements six months after their injection.

The volunteers did report some bruising, redness and swelling, however these were tolerable and most were resolved within two weeks.