Generic Name: non-animal stabilized hyaluronic acid (NASHA) injectable gel
Approved: December 12, 2003
Company: Medicis
Treatment for: Facial Wrinkles
FDA Approval Letter for Restylane on PDF
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(TM)). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin.
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.
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.
Clinical Study
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(R) (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)(1) and Global Aesthetic Improvement Scale (GAIS)(2). Adverse events were assessed by the treating investigator for severity and relationship to the study treatment.
The study found that Restylane showed a statistically significant difference over Zyplast with respect to the change (from pre-treatment) in WSRS score at all post-baseline timepoints (p less than 0.0001). Specifically, at six months post-baseline, Restylane was better than Zyplast in 56.9 percent of patients while Zyplast was better than Restylane in 9.5 percent of patients (p less than 0.0001). In addition, at six months, 67.2 percent of Zyplast-treated folds had returned to pre-treatment condition, compared with only 29.9 percent of Restylane-treated folds. Further, the total injection volume needed to produce an "optimal cosmetic result" was lower for Restylane (mean 1.0mL; range 0.3-2.8mL) than Zyplast (mean 1.6mL; range 0.1 - 5.0mL).
The most commonly reported adverse events were redness and swelling, which typically occurred at the injection site and were transient and mild to moderate in intensity.
About Restylane® & NASHA
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.
Source: Medicis (manufacturer of Restylane ® )
For more information, or updates, visit www.medicis.com
