SANTA MONICA, CALIF. Dysport is on its way; ArteFill won't be gone for long; and Juvéderm will soon be available in a formulation with lidocaine.
The already rapidly evolving array of cosmetic dermatology products is about to expand again, and in a big way, speakers said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation (SDEF). "Dysport is going to be here as soon as it gets through customs," said Dr. Christopher B. Zachary, professor and chair of dermatology at the University of California, Irvine.
The agent, approved by the Food and Drug Administration on April 30 for the temporary treatment of glabellar lines, represents the first widely available U.S. competitor to Allergan's botulinum toxin type A, Botox.
Many studies comparing Botox and Dysport have been hampered by disparate methodology, including the timelines for results and means of assessment, explained Dr. David Goldberg, clinical professor of dermatology and director of laser research at Mount Sinai School of Medicine in New York.
"It's going to be very interesting to see what happens when thousands of injections are given [and we'll] see if there are real differences," said Dr. Goldberg.
Two more botulinum toxin type A formulations are on the horizon, although they have yet to receive FDA approval: Xeomin from Merz Pharmaceuticals of Germany, and PurTox from Mentor Corp.
In other breaking news, Dr. Goldberg said dermatologists will not have to wait long for new shipments of ArteFill, the only filler FDA approved for cosmetic use.
The manufacturer of ArteFill, Artes Medical Inc., of San Diego, declared bankruptcy in December, but a new company, Suneva Medical Inc., was formed in April to take over the manufacturing and distribution of the deep dermal filler made of microspheres of polymethylmethacrylate (PMMA) in bovine collagen.
Juvéderm, a mid-dermal filler made of cross-linked hyaluronic acid, will soon be available in a formulation containing lidocaine, in line with its only FDA-approved hyaluronic acid competitor, Prevelle Silk by Mentor Corp., said Dr. Goldberg.
The hyaluronic acid filler market is poised to grow and perhaps will even spur a price war, he added.
"You can be sure there will be so many more. My prediction is that if the filler market is not glutted already now, it will be incredibly glutted over the next few years. All you have to do is to go to Europe and see 20, 25 different hyaluronic acid products," he said.
Not all fillers seem immediately destined for the U.S. market, however.
Isolagen Inc., which has created a permanent natural filler derived from a patient's autologous fibroblasts grown in culture, is reportedly in financial trouble and may file for bankruptcy, according to media reports, said Dr. Goldberg.
The company's biologicals license application for the product was accepted for full review by the FDA in May, but the company appears to be struggling, he said. While novel and intriguing, the product is "extraordinarily expensive" in Europe.
Dr. Zachary reported no relevant disclosures. Dr. Goldberg has received research grants, served as a consultant for, or been on a speakers bureau for numerous filler manufacturers, including Allergan, Mentor Corp., and Coapt Systems Inc.
SDEF and this news organization are owned by Elsevier.
Watch a video interview with Dr. Goldberg at https://www.youtube.com/SkinAndAllergyNews
'Dysport isgoing to be here as soon as itgets through customs,' bringing Botox its first competitor. DR. ZACHARY