The FDA has approved Prevelle Silk, part of a new line of lidocaine-containing hyaluronic acid (HA) dermal fillers, according to the drug’s manufacturer, Mentor Corp, Santa Barbara, Calif.
Prevelle Silk is a colorless HA gel with lidocaine that is injected into facial skin to reduce moderate to severe facial lines, folds, and wrinkles.
The product is the first in a new line of HA dermal fillers that Mentor is developing with Genzyme Corp.
In a controlled clinical study, patients experienced significantly less pain during injection with Prevelle Silk when compared to an HA product that did not contain lidocaine.
"We believe both patients and physicians will be excited to have an effective dermal filler option with lidocaine to help make the filler injection more comfortable," said Brian Luedtke, vice president of global marketing and sales for Mentor. "We believe Prevelle Silk will be an excellent complement to our portfolio of lidocaine-containing HA dermal fillers, the second of which is under review with FDA and the third in clinical trial. We will shortly begin targeted launch efforts to experienced dermatology and plastic surgery dermal filler customers, and anticipate a broader US commercial launch in combination with our second dermal filler later this year."
[Source: Mentor Corp]