National report - The U.S. fillers market is poised to explode with a host of new facial aesthetic products now awaiting federal approval, and still more in the pipeline.
"Everyone's looking for the new Botox," says William Philip Werschler, M.D., assistant clinical professor of medicine/dermatology at the University of Washington School of Medicine. "Even though Botox is a toxin, and toxins aren't technically fillers, you have to mention them in the same breath because of what they both do aesthetically. You also have to realize that in Europe - it's where most fillers come from and it's the most mature fillers market - the ratio of fillers to toxins is 3-to-1, while in the U.S. that ratio is 1-to-3.
Restylane, the hyaluronic dermal filler marketed by Scottsdale, Ariz.-based Medicis, faces the leading edge of the new wave now that Juvederm, marketed in the United States by Irvine, Calif.-based Allergan (which also markets Botox), has won Food and Drug Administration (FDA) approval.
Juvederm may even have a competitive leg up on Restylane, inasmuch as the Juvederm "family" of products - which includes three viscosities of fillers for various indications - has been approved, unlike the yet-to-be-approved members of the Restylane filler family.
According to Dr. Werschler - who has used or been involved in clinical tests of all U.S. companies' available filler products - the Restylane family members awaiting approval are Restylane Fine Line, a lower-viscosity filler for smoothing superficial wrinkles; Perlane, a slightly heavier product than Restylane, for shaping facial contours, defining cheeks, eliminating deep folds and enlarging lips; and Sub-Q, the heaviest-viscosity Restylane filler, used for procedures that require deeper injections.
All are currently used outside the United States, but of this group only Perlane is nearing FDA approval, according to Dr. Werschler.
"Perlane will be next Restylane-family product to be approved, and it will compete directly with Juvederm HV-30," he says. "Allergan also is marketing Juvederm 30 and Juvederm HV-24, which will compete directly with the Restylane base product. Juvederm will be the most competition out there with Restylane for aesthetic procedures until the other Restylane-family products get approved, which we may begin seeing by autumn."
Medicis Chief Scientific Officer Mitchell Wortzman said he expects Perlane to win FDA approval by the fourth quarter, but said that due to FDA regulations he cannot comment on the company's yet-to-be-approved products.
Also looming on the approval horizon is ArteFill, known as Artecoll outside the United States and used for correction of facial wrinkles, lines, furrows and acne scars. Manufactured by San Diego-based Artes Medical, the filler consists of polymethylmethacrylate (PMMA) beads suspended in bovine collagen. ArteFill was recommended for FDA approval years ago, but that approval is still pending.
"My opinion is ArteFill would have been a blockbuster years ago, but now I think it will only be a niche product," Dr. Werschler says.