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FDA approves hyaluronic acid dermal filler
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U.S. regulators last week gave marketing approval to a hyaluronic acid dermal filler. The injectable product was approved for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, according to the product’s marketer.
Restylane is the “first and only” Food and Drug Administration-approved dermal filler made of stabilized hyaluronic acid from a non-animal source, according to a press release from Medicis, the product’s U.S. marketer. Restylane, formulated as a clear gel, uses a dual mechanism of action to correct wrinkles and folds, according to the press release.
FDA approval was based on the conclusions of a 6-month randomized, multicenter study evaluating 138 patients seeking correction of bilateral nasolabial folds. Patients received Restylane 20 mg/mL in one nasolabial fold and Zyplast (cross-linked bovine collagen, Inamed) 35 mg/mL in the opposite fold. Zyplast is considered the gold standard of dermal fillers, according to marketer Inamed.
Clinical efficacy was assessed at 2, 4 and 6 months, and Restylane showed a statistically significant advantage over Zyplast at all time points, according to the press release. Also, at 6 months 30% of Restylane-treated folds had returned to pretreatment levels compared to 67% of the Zyplast-treated folds.
Medicis anticipates shipping the product within the next 30 to 60 days. The drug is manufactured by Sweden’s Q-Med and is marketed in more than 60 countries outside the United States.
Inamed and partner Genzyme are also awaiting FDA approval for their hyaluronic acid-based cosmetic dermal filler, Hylaform. That hylan-B gel was recommended for approval by an FDA advisory panel on the same day as Restylane, Nov. 21.
For more information on dermal fillers, click here.