Medicis Receives Approval for Restylane and Perlane with Lidocaine

Medicis recently announced that the FDA has approved the dermal fillers Restylane-L and Perlane-L, new formulations of Restylane and Perlane with Lidocaine. Restylane-L is approved for implantation into the mid to deep dermis, and Perlane-L is approved for implantation into the deep dermis to superficial subcutis, both for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

In clinical studies supporting approval, the addition of lidocaine to Restylane and Perlane substantially 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, respectively, in the treatment of moderate to severe nasolabial folds were evaluated in separate prospective randomized, double-blind, controlled clinical studies involving 120 total patients (60 patients each). Patients were followed for up to 14 days after injection. In the separate Restylane-L and Perlane-L studies, patients were injected with Restylane-L or Perlane-L in one nasolabial fold and Restylane or Perlane in the other nasolabial fold, respectively. Using a validated visual analog scale (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 the Restylane and Perlane products, at least 95% of patients rated the appearance of their nasolabial folds as improved, much improved or very much improved at the end of both studies, according to the company.

Medicis anticipates shipping Restylane-L and Perlane-L within the next 30 days. McKesson will serve as U.S. distributor. Physicians wanting to place orders for Restylane-L and Perlane-L should call McKesson directly at (877) 520-0500.

Allergan Announces FDA Approval of JUVÉDERM XC with Lidocaine

Allergan, Inc., recently announced the FDA approval of Juvéderm XC, a new formulation of the currently FDA-approved Juvéderm dermal filler. This new Juvéderm formulation contains lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds.

The Juvéderm XC formulation with 0.3% preservative-free lidocaine numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic, according to Allergan.

The FDA approval of Juvéderm XC was based on data from a multicenter, double-blind, randomized clinical trial, according to the company. A total of 72 patients were followed for 2 weeks after treatment with one of two Juvéderm formulations (Juvéderm XC with lidocaine or Juvéderm without lidocaine) in each nasolabial fold. In the clinical study (n=72), 93% of patients reported less pain when treated with the new formulation compared to those treated with the non-lidocaine formulation. Juvéderm XC was found to be more effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation.

The new formulation of Juvéderm with lidocaine is available for ordering nationwide. For more information, visit www.juvéderm.com.

Palomar Medical Technologies Announces Approval of its Fractional Laser to Treat Striae

Palomar Medical Technologies, Inc., announced its Lux1540 Fractional non-ablative laser handpiece recently received FDA approval for the treatment of striae.

According to Palomar, ongoing clinical studies have shown that patients treated with the Lux1540 achieved an average improvement of between 51% and 75% in the appearance of their striae, based upon a blinded review of photographs comparing the pre-treatment appearance of striae versus the results 3 months post-treatment.

“For the right patient, the Lux1540 provides a laser treatment option for stretch marks that offers significant improvement. The non-ablative fractional laser allows for comfortable treatments with little to no impact on the patient’s daily activities,” said Vic Narurkar, MD, a dermatologist in San Francisco, CA and Past President of the American Society of Cosmetic Dermatology and Aesthetic Surgery, in a press release.

This new clearance expands the range of treatments offered by the Lux1540, which may be used to treat surgical scars, acne scars, and melasma, as well as offering non-ablative skin resurfacing.

In conjuction with this approval, Palomar and Body1.com released a consumer education site, Stretchmarks1.com, to offer consumers more information about treatment options and as a way to locate providers of this treatment.

The Lux1540 Fractional non-ablative laser handpiece is available for use with Palomar’s StarLux 500 laser and pulsed light platform. The StarLux 500 allows practitioners to attach a variety of application-specific handpieces to one base unit.

For more information, please visit www.palomarmedical.com.