Washington - The Food and Drug Administration (FDA)'s General and Plastic Surgery Advisory Panel has recommended that Radiesse, a soft-tissue augmentation product manufactured and distributed by San Mateo, Calif.-based BioForm Medical, be approved for use in restoring facial contours such as nasolabial folds and in treating facial lipoatrophy associated with HIV.
Radiesse is an injectable filler composed of calcium hydroxylapatite (CaHA) particles suspended in a gel carrier. The product already had won FDA approval for oral/maxillofacial therapy, treating vocal fold insufficiency and for radiographic tissue marking.
Lipoatrophy, lines, wrinkles
According to a statement on the FDA Web site, the PMA for Radiesse to treat HIV-associated lipoatrophy was recommended as approvable with conditions by a five-to-two vote. Among those conditions are training for physicians, 18-month post-approval study and the inclusion in labeling of a precaution that the product has only been tested in HIV-lipoatrophy patients.
The second PMA, for correction of facial lines and wrinkles, was recommended for approval by a five-to-two vote with conditions that included a post-approval study to assess the duration of effect, timing of repeat treatments and long-term safety; a second post-approval study to gather additional safety data in people of color who are more likely to develop keloid or hypertrophic scarring; and that labeling include a precaution that Radiesse has not been adequately studied in people of color.
Although cautioning that there is no accurate way to predict when or even if the FDA will give final approval to Radiesse for these two indications, BioForm President and C.E.O. Steve Basta says he expects the device (the FDA term under which Radiesse is categorized) to be approved by first-quarter 2007 at the latest.
Mr. Basta adds that he sees Radiesse as the "next evolution" in a United States filler market that's already showing signs of becoming huge.
"The advent of collagen fillers a few years ago brought the market to about $70 million annually, and with the advent of Restylane (Medicis) a year later that market has grown to about $200 million to $250 million," he says.
"Due largely to that fact that studies show Radiesse's post-treatment durability to be a year to one-and-a-half years - twice that of other fillers currently available in the U.S. - we think Radiesse is a next-generation product that will make a huge market impact."
Ushering in a boom
That impact could be dramatic, says BioForm V.P. of Corporate Development Adam Gridley.
"The presence of Radiesse and other fillers, once they're approved, will be significant," he says. "Who knows exactly where it will all go, but I think it's reasonable to expect the filler market to reach $500 million over the next couple of years."
Physicians who have used Radiesse confirm Basta's claim regarding its durability. Lawrence S. Bass, M.D., director of minimally invasive plastic surgery at New York University Medical Center, has been using Radiesse off-label for about four years as part of an academic clinical study. He also was a site investigator in the FDA's nasolabial correction clinical trial.
He tells Dermatology Times, "Radiesse is the longest-lasting biological filler available in the United States, with durability of one to 1.5 years on average. Other fillers available or under development that I am aware of have either shorter durability or are not biological materials, meaning the safety of the material must be prospectively demonstrated in widespread application."
David J. Goldberg, M.D., who practices privately in New York and New Jersey and is director of Mohs surgery and laser research at Mount Sinai School of Medicine in New York, has been investigating Radiesse for three years and has co-authored two papers on it.
"Radiesse differs from fillers already on the U.S. market because it's longer lasting and a non-hyaluronic-acid product that generates immediate results," he says. "Once approved, it will impact the practice of aesthetic dermatology by expanding the filler and dermal volume-enhancement market."