FDA approves first HA-lidocaine filler for U.S. market
The recent FDA approval of Prevelle Silk (Mentor, Santa Barbara, Calif.) represents the first in what will likely be a wave of hyaluronic acid (HA) dermal fillers containing lidocaine coming to the U.S. market.
The product was approved in March after a controlled clinical study indicated that patients experienced significantly less pain during injection with the product compared to an HA product without lidocaine. It is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
HA fillers such as Juvéderm Ultra (Allergan, Irvine, Calif.) are already sold in Europe in formulas containing lidocaine and more are expected to hit the U.S. market as companies see consumer and marketing appeal in including an agent to reduce pain during injection.
But with many physicians already going the extra yard to reduce pain well before the syringe is even filled, some question the value of a pain reliever that can take effect practically after the fact.
THE NUMB-ER THE BETTER “The issue with a hyaluronic acid filler with lidocaine is that it doesn’t work until you actually start injecting patients, and these injections are so quick, by the time the lidocaine takes effect, you’re almost finished,” Joe Niamtu, D.M.D., tells Cosmetic Surgery Times.
Company news release:
SANTA BARBARA, Calif., Mar 21, 2008 (BUSINESS WIRE) — Mentor Corporation (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, today announced that the Food and Drug Administration (FDA) has approved Prevelle Silk. This is the first of a new line of lidocaine containing hyaluronic acid (HA) dermal fillers that Mentor anticipates marketing and distributing globally.
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 Corporation (NASDAQ: GENZ). Lidocaine, a local anesthetic, is added to provide pain relief at the site of the injection. 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.
Mentor Corporation has forged a strategic development partnership with Genzyme Corporation, a global leader in the development and manufacturing of HA products. Mentor Corporation will market and distribute the products globally.
“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 of Mentor Corporation. “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 U.S. commercial launch in combination with our second dermal filler later this year.”
About Prevelle Silk
PREVELLE SILK is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). In clinical studies, adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common side effects included temporary injection site reactions such as swelling, pain/tenderness, redness, and lumps/bumps.
About Mentor Corporation
Mentor is a leading supplier of medical products for the global aesthetic market. The Company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve their quality of life. The Company’s website is www.mentorcorp.com.
