The Food and Drug Administration (FDA) has approved Restylane® Defyne (Galderma) for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21 years.
Restylane Defyne is a sterile, clear, homogeneous soft hyaluronic acid gel containing 3mg/mL of lidocaine hydrochloride. The approval was based on data from a randomized, no-treatment controlled, evaluator-blinded phase 3 trial that evaluated the efficacy and safety of Restylane Defyne in adults 22 years of age and older for chin augmentation and correction of chin retrusion.
Results showed that 74% of Restylane Defyne-treated patients achieved significantly improved chin projection for up to 1 year as measured by the Galderma Chin Retrusion Scale (GCRS); 86% of patients achieved GCRS improvement as early as 12 weeks.
Additionally, the trial met key secondary end points including positive aesthetic outcomes in FACE-Q and Global Aesthetic Improvement Scale (GAIS) questionnaires. At 12 weeks, 99% of patients reported improvement in the appearance of their chin projection, and 96% of injectors reported improvement in the appearance of the patients’ chin projection up to 1 year.
Restylane Defyne is also indicated for the correction of moderate to severe, deep facial wrinkles and folds in patients over the age of 21. Restylane Defyne is part of a family of aesthetic medicine products that include Restylane, Restylane-L, Restylane Lyft with Lidocaine, Restylane Silk, Restylane Refyne, and Restylane Kysse.
Galderma receives FDA approval for Restylane® Defyne for chin augmentation. [press release]. Fort Worth, TX: Galderma; February 1, 2021.