FDA Panel to Review New Wrinkle Treatment
Maker Artes Medical, a privately held company based in San Diego, says its Artecoll injection of bovine-collagen-containing polymer spheres permanently fills wrinkles with rare complications in patients currently receiving the treatment.
Artecoll is already available in Europe, Canada, Mexico and Asia, the company's medical chief executive, Stefan Lemperle, said.
If approved in the United States it would be marketed under the brand name Artefill.
In the review, the Food and Drug Administration's General and Plastic Surgery Devices Panel plans to weigh the safety and effectiveness of Artecoll.
The agency usually follows the advice of its advisory panels.
The plastic in Artecoll is polymethylmethacrylate, or PMMA for short, a material used for more than 50 years in medical devices ranging from contact lenses to bone implants.
The PMMA spheres, about the thickness of a human hair, settle in the wrinkle as the collagen gradually absorb into the body, said Lemperle in a phone interview. Then, the spheres stimulate the body's own collagen to encapsulate them, he said.
Patients see "immediate results, just as with collagen. The only difference is collagen goes away and Artecoll doesn't," Lemperle said.
Artecoll patients usually return for a final touch-up in about two months, Lemperle said.
With Allergan Inc.'s Botox, which paralyzes muscles to soften wrinkles, patients need repeat injections about every three months or so for maintenance.
FDA staff who reviewed trial data on Artecoll saw superior results over collagen alone when Artecoll was used to smooth the facial creases that run from the nose to the corner of the mouth--known as the nasolabial fold.
Regarding side effects, Lemperle said one out of every 10,000 patients worldwide experienced a reaction to the Artecoll injection that resulted in a nodule, or lump, under the skin. That can be corrected easily with cortisone shots, he said. (Reuters)