FDA Approves Galderma’s Restylane Refyne and Restylane Defyne Dermal Fillers


The Restylane Refyne and Restylane Defyne Dermal Fillers have been FDA approved for the treatment of nasolabial folds 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.

The hyaluronic acid dermal fillers are manufactured with XpresHAn Technology, which offers 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.

After initial treatment, injection site responses included:

  • Redness
  • Swelling
  • Bruising
  • Lump/bump formation
  • Pain/tenderness

The responses were predominantly mild or moderate in intensity, temporary (typically with a duration of one to two weeks), and similar for the Restylane products. 

The FDA approval was based on two 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 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, a validated five-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 percent of Restylane Refyne subjects and 77 percent of Restylane Defyne subjects had at least a one-grade improvement on the WSRS after six weeks. Subjects also performed self-assessments (SSA) of wrinkle severity, with most subjects reporting at least a one-grade improvement in SSA scores with Restylane Refyne and with Restylane Defyne after six weeks.

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