Galderma’s Restylane Fillers Receive FDA Approval

Galderma, a global medical solutions company focusing on skin health, received U.S. Food and Drug Administration (FDA) approval of two new products for the treatment of nasolabial folds, commonly known as laugh lines. Restylane Refyne was approved for the treatment of moderate to severe facial wrinkles and folds and Restylane Defyne for the treatment of moderate to severe, deep facial wrinkles and folds. These scientifically advanced gels are manufactured with XpresHAn Technology, which allows for a range of flexibility and support for varied patient needs, and effective treatment for up to 12 months. “Even with current approved options, many of my patients are still looking for different solutions to treat their laugh lines,” says Steven Fagien, M.D., Boca Raton-based oculoplastic surgeon and Restylane Refyne clinical investigator. “These new products are flexible and are designed to meet different patient needs. I am excited to offer these next-generation hyaluronic acid (HA) dermal fillers in my practice.”

Two double-blinded, randomized, and active-controlled Phase Three studies confirmed the efficacy and safety of both fillers. Investigators used the Wrinkle Severity Rating Scale (WSRS), a validated 5-point measure of the size and depth of the wrinkles, to quantify the effects of the fillers. Six weeks after injection of both fillers, nearly 80 percent of patients saw at least a 1-point improvement in wrinkles on the WSRS and in self-assessments. “Restylane Refyne and Restylane Defyne are the latest FDA-approved advancements in HA dermal fillers and align with Galderma’s mission to help individuals achieve natural-looking results through treatments with a long-standing history of proven safety and efficacy,” says Kelly Huang, Ph.D., vice president and general manager of the U.S. Aesthetic and Corrective business of Galderma. “We saw an opportunity to address a common concern for patients who have not yet tried a dermal filler by designing gels that provide natural-looking results. With these new brands, the Restylane family of products now represents the broadest offering of HA dermal fillers in the U.S.”