Galderma has received U.S. Food and Drug Administration (FDA) approval of two new products for the treatment of nasolabial folds (NLF) or “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. Refyne and Defyne have been shown to maintain effectiveness for the treatment of laugh lines for up to 12 months.1,2
The FDA approval was based on two pivotal, double-blinded, randomized, active-controlled Phase 3 studies investigating Refyne and Defyne (involving 171 and 162 subjects, respectively) to evaluate their safety and effectiveness. In both studies, Refyne and Defyne met the studies’ endpoints, with both products 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. Investigators reported that 79% of Refyne subjects and 77% of Defyne subjects had at least a 1-grade improvement on the WSRS after 6 weeks. Subjects also performed self-assessments (SSA) of wrinkle severity, with most subjects reporting at least a 1-grade improvement in SSA scores with Refyne and with Defyne after 6 weeks.
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).
Restylane Refyne and Restylane Defyne were first approved in Europe in 2010 under the brand name Emervel.
The Restylane line of hyaluronic acid fillers is used to help smooth away wrinkles (Restylane & Restylane Lyft), create fuller and more accentuated lips (Restylane Silk), and add lift and volume to the cheeks (Restylane Lyft).