Phase 3 data showed that Galderma’s Restylane Defyne led to a significant improvement in chin projection for up to 1 year in 74% of patients.
The US Food and Drug Administration (FDA) has approved Galderma’s Restylane® Defyne for the augmentation and correction of mild-to-moderate chin retrusion in adults >21 years of age.
"This marks Galderma's 8th FDA aesthetics approval in 5 years, illustrating our long-term commitment to advancing aesthetics through new innovation," said Alisa Lask, General Manager and Vice President of the U.S. Aesthetics Business at Galderma, in a statement.
“The chin is the foundational anchor of the face that brings the rest of your features into balance. Consumers can now address the chin with a non-surgical, safe option from a brand that uses cutting-edge XpresHAn Technology to shape and produce long-lasting results," she continued.
The approval is supported by Phase 3 data that showed that 74% of patients experienced significantly improved chin projection for up to 1 year, which was measured by the Galderma Chin Retrusion Scale (GCRS).
Further, according to the GCRS, 86% of patients experienced improvement at week 12.
Patients also expressed high levels of satisfaction with aesthetic outcomes on the FACE-Q and Global Aesthetic Scale (GAIS) questionnaires.
As such, 99% of patients reported improvement in the appearance of their chin 12 weeks post-treatment, while 96% of injectors noted that treatment improved the appearance of patient chin projection up to 1 year.
In terms of safety, 86% of patients did not experience any adverse events related to treatment. Furthermore, 96% of treatment-related adverse events were mild in severity, with only 1 moderate event of injection site pain.
Restylane Defyne was first approved in 2016 by the FDA for mid-to-deep injection for the correction of moderate-to-severe deep facial wrinkles and folds in patients over 21 years of age.