Medicis announced that the US FDA has approved Restylane, an injection for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, the lines between the nose and mouth. Restylane is the first and only FDA-approved dermal filler made of a biodegradable non-animal stabilized hyaluronic acid (NASHA). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin.
"The approval of Restylane is not only a very important milestone in the history of Medicis, but also represents a significant advance in cosmetic dermal fillers," said Jonah Shacknai, chairman and CEO of Medicis. "With its proven track record for long-lasting efficacy and safety in more than one million procedures worldwide, we believe that Restylane will set a new standard for non-invasive cosmetic procedures."
Restylane is formulated as a clear gel and uses a dual mechanism of action to correct wrinkles and folds. Upon being injected beneath the skin's surface, the NASHA gel adds natural volume and lift to smooth wrinkles and folds. The NASHA gel integrates into dermal tissue then attracts and binds to water molecules to help maintain volume. Restylane is gradually degraded by the body's own mechanism and disappears without any residue. Results can be seen immediately following treatment and last six months, or even longer.
"The arrival of Restylane to the US has been long-awaited by physicians and consumers alike given its worldwide safety record and reputation as the ideal solution to eliminate wrinkles and facial folds," said Rod J Rohrich, MD, FACS, chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center and president of the American Society of Plastic Surgeons. "Restylane represents the future of cosmetic dermal fillers in that it's completely natural and biodegradable, is non-animal derived so it does not pose a risk of disease transmission, and has been shown to last longer than six months, which is better than any currently available non-permanent dermal filler."
Restylane is marketed and sold in more than 60 countries outside the US where it has been used in more than one million procedures. Since 1996, dermatologists and plastic surgeons outside the US have used it to contour and restore volume to skin and temporarily eliminate wrinkles and facial folds. Additionally, in countries other than the US, Restylane is also approved to enhance the appearance and fullness of lips, although the safety or efficacy of Restylane for the treatment of lips has not been established in controlled clinical studies submitted to the FDA.
Medicis anticipates shipping Restylane during the next 30 to 60 days. McKesson will serve as US distributor for Restylane. Restylane is manufactured by Q-Med in Uppsala, Sweden.
"Restylane promises to make its mark as the non-invasive treatment of choice in the US given the unique advantages it offers to both patients and physicians," added Dr Rohrich. "For patients, Restylane is safe, its results are evident right after treatment, and there is no six week wait for allergy testing. For physicians, Restylane is readily prepared and easy to inject, requires less material to achieve desired volume than collagen and given its durability, requires fewer treatment sessions."
Medicis Aesthetics Inc., the company that is marketing and selling Restylane in the US, is a wholly-owned subsidiary of Medicis Pharmaceutical Corporation, a leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of aesthetic, dermatological, pediatric and podiatric conditions.