More dermal fillers on their way to market

ANAHEIM, Calif. — Dermal fillers are effective tools for cosmetic treatment of the lips and nasolabial folds, but U.S. surgeons have been limited in their access to the dozens of products currently in use in Europe, a speaker here said. That may change soon, as data on two products are scheduled to be reviewed by a regulatory panel next week, and several others are also on the way.

Currently, the only dermal fillers approved by the Food and Drug Administration are bovine collagen products, said Jeffrey S. Dover, MD, FRCPC, a featured speaker here at the American Society of Ophthalmic Plastic and Reconstructive Surgery meeting. Zyderm and Zyplast, both from Inamed Aesthetics, were approved earlier this year. But Dr. Dover noted that dozens of filler materials, including animal- and human-derived collagen, hyaluronic acid, silicone, plastics and other materials are used by oculoplastic surgeons internationally.

Data on two hyaluronic-acid-based dermal fillers will be reviewed at an FDA advisory panel meeting on November 21. These are Restylane, made with hyaluronic acid from a bacterial source by Q-Med, and Hylaform, made with hylan B from rooster combs by Inamed, Dr. Dover said. According to the FDA Web site, the two premarket applications to be reviewed are for “injectable devices intended to restore soft tissue facial contours such as nasolabial folds.”

Dr. Dover, who has investigated these products and several others that are in the FDA approval pipeline, said the cosmetic effect of the hyaluronic-acid-based fillers lasts about twice as long as the currently approved bovine collagen fillers, about 6 to 8 months. He said the injection technique is similar to the technique used with collagen, either a linear fill technique or serial punctures. Only about half the amount of Restylane as collagen is needed to get the same cosmetic effect, he said

The hyaluronic acid fillers have a natural look and feel and are malleable, he said.