Restylane-L and Perlane-L dermal fillers approved

The FDA has approved Medicis’ hyaluronic acid with lidocaine dermal fillers, Restylane-L and Perlane-L. This approval was based on clinical data that demonstrated Restylane-L and Perlane-L to substantially reduce pain experienced by patients compared to Restylane and Perlane without lidocaine. At the time of injection, 71.7% of patients in the Restylane-L study and 95% of patients in the Perlane-L study had a within-patient difference in the validated visual analog scale (VAS) of at least 10mm favoring Restylane-L and Perlane-L.

Restylane and Restylane-L have a gel particle structure designed for injection in the mid to deep dermis for structural support and lift, smoothing away moderate to severe facial wrinkles and folds (eg, nasolabial folds). Perlane and Perlane-L have the same gel particle structure as Restylane, but with a larger median gel particle size, and are designed for injection into the deep dermis to superficial subcutis.

Restylane-L will be available in 1mL and 0.5mL syringe sizes. Perlane-L will be available in 1mL syringe size.

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