Wednesday, dermatological drug maker Medicis Pharmaceutical Corp. (MRX) said the U.S Food and Drug Administration has approved its dermal fillers Restylane-L and Perlane-L, the anesthetic lidocaine-added versions of lip augmentation injection Restylane and Perlane wrinkle softener.
Restylane-L was approved for implantation into the mid to deep dermis while Perlane-L was approved for implantation into the deep dermis to superficial subcutis, both indicated for the correction of moderate to severe facial wrinkles and folds, Medicis said.
Jonah Shacknai, chief executive officer of Medicis, said, "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."
In clinical studies, the addition of lidocaine to Restylane, which is commonly used for lip augmentation, and Perlane wrinkle softener substantially reduced pain experienced by patients, while demonstrating adverse event safety profiles similar to those of Restylane and Perlane, Medicis said.
The safety, tolerability, and pain reduction of Restylane-L and Perlane-L, compared to Restylane and Perlane, respectively, in the treatment of moderate to severe nasolabial folds, or NLF, were evaluated in separate prospective randomized, double-blind, controlled clinical studies involving 120 total patients.
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. Using a validated visual analog scale, or VAS, composed of a straight line representing a continuum from no pain to worst pain, subjects evaluated injection site pain for each side of the face.
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 VAS of at least 10 mm favoring Restylane-L and Perlane-L. A within-patient difference in pain of at least 10 mm on the VAS was defined as meaningful.
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, Medicis said. The Restylane Collection of products includes Restylane, Restylane-L, Perlane and Perlane-L.
Medicis announced that it would begin shipping both the products within the next 30 days. McKesson Corp. (MCK) would be the distributor for both products in the U.S, Medicis revealed.
MRX is losing $0.49 or 2.04%, and is trading at $23.50 on a volume of 359 thousand shares on the New York Stock Exchange.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.