Galderma announced that the Food and Drug Administration (FDA) approved 2 new dermal fillers for the treatment of nasolabial folds (NLF), also known as “laugh lines,” in patients aged >21 years old.

Restylane Refyne is indicated for the treatment of moderate to severe facial wrinkles and folds. Restylane Defyne is indicated for the treatment of moderate to severe, deep facial wrinkles and folds. The two hyaluronic acid products utilize XpresHAn Technology that creates a smooth, injectable gel with a range of flexibility and support for various needs. The technology customizes the degree of hyaluronic acid crosslinking in each product. Restylane Refyne is created to be very flexible with subtle support whereas Restylane Defyne is created to be less flexible with extra support. 

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The approval was supported by 2 double-blinded, randomized, active-controlled Phase 3 studies that evaluated Restylane Refyne (n=171) and Restylane Defyne (n=162). Both studies met their endpoints by demonstrating a clinically meaningful improvement in wrinkle severity for up to 12 months in the majority of patents. The Wrinkle Severity Rating Scale (WSRS), a 5-point measure, was used to measure the size and depth of the wrinkles. 

The data showed 79% of Restylane Refyne patients and 77% of Restylane Defyne patients exhibited at least a 1-grade improvement on the WSRS after 6 weeks. Also, study participants who took self-assessments of wrinkle severity, reported at least a 1-grade improvement in scores with Restylane Refyne and Restylane Defyne after 6 weeks. Injection site reactions were temporary, mostly mild or moderate in severity, and similar between the Restylane products. 

Currently, there are 3 ongoing Phase 4 studies to assess the effects of Restylane Refyne and Restylane Defyne. 

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