FDA approves BioForm's dermal filler

NEW YORK (CNNMoney.com) -- The FDA approved a new dermal filler from BioForm Medical, the company said, adding competition to a market currently dominated by Medicis and Allergan.

Privately-held BioForm, based in San Mateo, Calif., said on Dec. 27 that its dermal filler Radiesse received a green light from the Food and Drug Administration as a long-lasting facial wrinkle-remover. The product was also approved as a treatment for the loss of facial fat in patients with human immunodeficiency virus, or HIV.

The approval brings a new contender to the growing but hotly competitive market for dermal fillers. The dermal filler market is estimated to be $250 million in the United States and $500 million worldwide.

In a recent interview, BioForm chief executive Steve Basta said his product is longer-lasting than the gel-based competing dermal fillers, because Radiesse contains particles as well as gel. The gel deteriorates after a few months, but collagen forms around the particles, allowing the dermal filler to last longer, according to Basta.

The lead dermal filler is Restylane from Medicis (up $0.10 to $35.87, Charts), a company based in Scottsdale, Ariz. But Medicis faces stiff competition from Allergan (up $1.55 to $120.43, Charts), the Irvine, Calif.-based maker of the dermal filler Juvederm, which the company launched in September.

Allergan also makes the injectable wrinkle-remover Botox. Botox and Juvederm affect different parts of the face, and Allergan could offer them both as a combination product. Medicis could offer a similar combination with Restylane if it gets its injectable facial remover Reloxin approved by the FDA. Reloxin is currently available in Europe as Dysport, produced by the French company Ipsen.

More dermal fillers are crowding the market.

The FDA in October approved ArteFill, a dermal filler from the privately-held Artes Medical, based in San Diego. This is a long-lasting product that the company refers to as "permanent."

Isolagen (up $0.01 to $2.86, Charts), based in Exton, Penn. and led by industry veteran Nicholas Teti, is also developing a dermal filler that uses the patient's own skin cells. The product is in late-stage testing.

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