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.

Source: HCPLIVE.COM

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