When Reloxin (Ipsen) eventually hits the U.S. market to challenge Botox (Allergan) as the new 800-pound gorilla of the facial aesthetics market, then it will be accurate to report the arrival of a new product with potentially huge market impact, dermatology sources say.
Until then, however, it appears the U.S. market will continue to see - as it has in the past year or so - a continuous stream of new products that, while not exactly blockbusters, represent evolutionary improvements over the old stand-bys.
She cites Perlane (Medicis, approved in May 2007), Juvéderm Ultra and Ultra Plus (Allergan, June 2007) and Prevelle Silk (Mentor Corp., March 2008).
"These products are really allowing us to customize treatment more than ever before," Dr. Hirsch tells Dermatology Times.
"This is the first hyaluronic acid filler in the United States that contains a local anesthetic to lessen injection discomfort," says Dr. Goldberg, director of Skin Laser & Surgery Specialists of New York/New Jersey and clinical professor of dermatology at New York's Mount Sinai School of Medicine. "Elevess is exciting, because for the first time a hyaluronic acid filler is being marketed with lidocaine as an anesthetic."
The more recently approved Prevelle Silk also contains lidocaine, and is, according to Mentor, the first in a line of HA-based fillers the company is developing with Genzyme Corp. of Cambridge, Mass.
Benefits of anesthetic
"None of these fillers will be a revolutionary product, in my opinion, but the addition of anesthetic to HA fillers is a huge improvement and long overdue," says Omaha, Neb., dermatologist Joel Schlessinger, M.D., immediate past president of the American Society of Cosmetic Dermatology & Aesthetic Surgery.
"Patients will see major benefits in pain, as well as the potential for less bruising due to less trauma from blocks prior to injection," he says.
Dr. Schlessinger tells Dermatology Times that several new fillers currently are in trials, but none that are significantly different from the newly approved products.
"There are fillers with anesthetic added that Allergan and Medicis have in the pipeline, and it appears that Allergan will be first to the market with theirs," he says.
"There also are numerous fillers commonly used overseas that manufacturers are planning to bring to the U.S. market, but many of these have not been tested thoroughly and may not make it. (German pharmaceutical company) Merz is in the final stages of testing for a new HA-based filler that will be here in 2009, with luck," Dr. Schlessinger says.
Dr. Goldberg says fillers in the pipeline are more robust HAs that will be used for facial volume improvement, as well as new calcium hydroxylapatite fillers.
"All of these are being spurred on because of the continued physician and patient interest in facial volume resculpturing without surgery," he says. "Expect FDA approval of some of these within the next year."