Medicis today announced that the U.S. Food and Drug Administration (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 Chief Executive Officer 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 U.S. 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, M.D., F.A.C.S., 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 United States where it has been used in more than one million procedures. Since 1996, dermatologists and plastic surgeons outside the U.S. have used it to contour and restore volume to skin and temporarily eliminate wrinkles and facial folds. Additionally, in countries other than the U.S., 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 U.S. distributor for Restylane. Physicians wanting to place orders for Restylane should call McKesson directly at 1-877-520-0500. Restylane will be available to patients through licensed practitioners. Restylane is manufactured by Q-Med in Uppsala, Sweden.

"Restylane promises to make its mark as the non-invasive treatment of choice in the U.S. 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."

The 6-month randomized, multi-center double-blind study evaluated 138 patients seeking correction of bilateral nasolabial folds (smile lines). Patients received Restylane (non-animal stabilized hyaluronic acid 20 mg/mL) in one nasolabial fold and Zyplast (cross-linked bovine collagen 35mg/mL, INAMED Corporation, Santa Barbara, CA) in the opposite nasolabial fold.

Clinical efficacy assessments were then conducted at two, four and six months after baseline using the Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS). Adverse events were assessed by the treating investigator for severity and relationship to the study treatment.

Restylane is the first and only dermal filler made of crystal-clear gel called NASHA (Non-Animal Stabilized Hyaluronic Acid). NASHA is developed using a unique stabilization process that results in its long duration of effect in contrast to non-stabilized hyaluronic acid, which lasts only days to weeks, at most. As opposed to other hyaluronic acid products, NASHA is not derived from animal sources. It is produced biotechnologically by natural fermentation in a sterile laboratory environment. This significantly diminishes the risk of transmitting diseases between species or of eliciting allergic reactions in patients who are sensitive to common foods, such as beef, chicken and eggs. NASHA has been extensively researched for over a decade and proven to be safe and effective. Restylane does not require any allergy or skin test prior to injection.