Galderma announced Dec. 12 the company has received U.S. Food and Drug Administration (FDA) approval of two new products for the treatment of nasolabial folds (NLF) or “laugh lines,” in patients over the age of 21.
Galderma, which bases its U.S. operations in Fort Worth, said 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 (pronounced ex-ˈspre-shən), creating gels that offer a range of flexibility and support for varied patient needs,” according to a company news release. Restylane Refyne and Restylane Defyne have been shown to maintain effectiveness for the treatment of laugh lines for up to 12 months, according to the company.
The FDA approval was based on two double-blinded, randomized, active-controlled Phase 3 studies investigating Restylane Refyne and Restylane Defyne, both involving over 150 subjects, to evaluate their safety and effectiveness. In both studies, the showed a clinically meaningful improvement in wrinkle severity for up to 12 months in the majority of patients, according to the Galderma news release.
“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,” said Kelly Huang, 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.”
Galderma is conducting three ongoing Phase 4 clinical studies to investigate the effects of Restylane Refyne and Restylane Defyne as patients conduct everyday expressions and the company said it will share those results as they become available.
The Restylane family of products is available only through a licensed practitioner.
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Swiss-based dermatology company Galderma Laboratories LP’s U.S. headquarters is in Fort Worth. The company built a new $22 million research and development center in Fort Worth this year. A wholly owned subsidiary of Nestle SA, Switzerland, Galderma is solely focused on dermatology and skin health. The company’s skin care line includes prescription medications, aesthetic and corrective medical solutions, and over-the-counter cleansers and moisturizers, including its iconic brand, Cetaphil.
In October, the company announced that Humberto Antunes, CEO of Nestle Skin Health S.A. and Chairman of the Board of Galderma Pharma S.A., was leaving the company, to be replaced by Paul Navarre, who started his career with Procter & Gamble before joining Allergan, a global pharmaceutical company, where he was most recently president of Allergan International.