Restylane (dermal filler) given new approvals by FDA for nasolabial folds- Galderma

Galderma has received FDA approval of two new products for the treatment of nasolabial folds (NLF) or "laugh lines," in patients over the age of 21. 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 gels are manufactured with XpresHAn Technology creating gels that offer a range of flexibility and support for varied patient needs. Restylane Refyne and Restylane Defyne have been shown to maintain effectiveness for the treatment of laugh lines for up to 12 months.

The FDA approval was based on two pivotal, double-blinded, randomized, active-controlled Phase III studies investigating Restylane Refyne and Restylane Defyne (involving 171 and 162 subjects, respectively) to evaluate their safety and effectiveness. In both studies, Restylane Refyne and Restylane 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 Restylane Refyne subjects and 77% of Restylane 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 Restylane Refyne and with Restylane Defyne after 6 weeks.