Medicis has received FDA approval for its dermal fillers Restylane-L and Perlane-L Restylane-L for implantation into the mid to deep dermis, and Perlane-L for implantation into the deep dermis to superficial subcutis. Both the fillers are approved for the treatment of moderate to severe facial wrinkles and folds.
The company said that the approval was based on the clinical studies which shows that the addition of lidocaine to Restylane and Perlane reduced pain experienced by patients, while demonstrating adverse event safety profiles similar to those of Restylane and Perlane.
The safety, tolerability and pain reduction of Restylane-L and Perlane-L, compared to Restylane and Perlane, in the treatment of moderate to severe nasolabial folds (NLF) were evaluated in separate prospective randomised, double-blind, controlled clinical studies involving 120 total patients (60 patients each).
Subjects were followed for up to 14 days after injection. In the separate Restylane-L and Perlane-L studies, subjects were injected with Restylane-L or Perlane-L in one NLF and Restylane or Perlane in the other NLF, respectively.
For all products in the Restylane collection, at least 95% of subjects rated the appearance of their NLFs as improved, much improved or very much improved at the end of both studies. The Restylane Collection of products includes Restylane, Restylane-L, Perlane and Perlane-L.
The company expects to start the shipping of Restylane-L and Perlane-L within the next 30 days. McKesson will serve as US distributor.
Jonah Shacknai, chairman and CEO of Medicis, said: “We are pleased to announce the approvals of Restylane-L and Perlane-L. Restylane is the first and only hyaluronic acid dermal filler approved to last up to 18 months with one repeat treatment. Physicians now have the option of providing Restylane or Perlane with an anesthetic to their patients in a single syringe.”