BioForm Medical Inc. said Wednesday that U.S. regulators approved its skin filler Radiesse to treat facial wrinkles and folds around the nose and upper lip.
The Food and Drug Administration also cleared the product for facial hollowing that sometimes affects people with HIV, the virus that causes AIDS, the San Mateo, Calif.-based company said.
Radiesse will compete in the market for injectable cosmetic products with Medicis Pharmaceutical Corp.'s Restylane, the top-selling wrinkle filler, and Allergan Inc.'s Juvederm. Sales of such treatments might rise 15% annually through 2010 to $935 million a year, according to Freedonia Group, a market research firm in Cleveland.
Doctors inject Radiesse below the skin's surface to increase thickness in the treated area, the company said. Botox, the refined botulinum toxin that generated $830.9 million in sales last year for Irvine-based Allergan, works by relaxing muscles in the face. Doctors often use multiple injectable products on patients, analyst said.
Radiesse, a water-based gel, contains particles of calcium hydroxylapatite, a biodegradable material that is similar to a component of bone, according to the company's website.