Galderma has received U.S. Food and Drug Administration (FDA) approval of two new Restylane products for the treatment of nasolabial folds (NLF) in patients over the age of 21. Restylane Refyne is 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. The dermal fillers have been shown to maintain effectiveness for the treatment of laugh lines for up to 12 months and are manufactured with XpresHAn Technology (pronounced ex-ˈspre-shən), which creates a smooth gel that offers flexibility and support for varied patient concerns. They were first approved in Europe in 2010 under the brand name Emervel, and have a proven safety profile demonstrated by more than one million treatments worldwide.
FDA approval was based on two pivotal, double-blinded, randomized, active-controlled Phase 3 studies investigating Restylane Refyne and Restylane Defyne (involving 171 and 162 subjects, respectively) to evaluate their safety and efficacy. Both fillers met the studies’ endpoints, showing a clinically meaningful improvement in wrinkle severity for up to 12 months in the majority of patients. Study investigators used the Wrinkle Severity Rating Scale (WSRS), a validated 5-point measure of the size and depth of the wrinkles, with grade 1 defined as absence of wrinkles and grade 5 as extremely deep and long wrinkles. They reported that 79% of Restylane Refyne subjects and 77% of Restylane Defyne subjects had at least a 1-grade improvement on the WSRS after six weeks. Subjects also performed self-assessments of wrinkle severity, with most reporting at least a 1-grade improvement with both Restylane Refyne and Restylane Defyne. After initial treatment, injection site responses (redness, swelling, bruising, lump/bump formation, pain/tenderness) were predominantly mild or moderate in intensity, temporary (typically with a duration of one to two weeks), and similar for both products.
“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 longstanding history of proven safety and efficacy,” said Kelly Huang, PhD, VP and general manager of Galderma’s U.S. Aesthetic and Corrective Business.
Galderma is currently conducting three ongoing Phase 4 clinical studies to investigate the effects of Restylane Refyne and Restylane Defyne as patients conduct everyday expressions.