FDA approves Restylane fillers for treatment of nasolabial folds

22 Dec 2016

The Food and Drug Administration (FDA) has approved Restylane Refyne and Restylane Defyne dermal fillers from Galderma for the treatment of nasolabial folds.

Patients over the age of 21 have been approved for the treatment of moderate to severe facial wrinkles and folds, which was based on two studies to evaluate the products’ effectiveness and safety.

In both studies, involving 171 and 162 participants, Restylane Refyne and Restylane Defyne met the studies’ endpoints, with both products showing an improvement in wrinkle severity for up to 12 months in the majority of patients. Study investigators used the Wrinkle Severity Rating Scale, reporting that 79% of Restylane Refyne subjects and 77% of Restylane Defyne subjects had at least a 1-grade improvement after six weeks. Vice president and general manager at Galderma’sAesthetic and Corrective Business Unit, Kelly Huang, said, “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.”


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