Restylane Defyne approved for chin augmentation
The FDA has approved Restylane Defyne for mild to moderate chin retrusion augmentation in adults older than 21 years, Galderma announced in a press release.
A hyaluronic acid dermal filler, Restylane Defyne was first approved in 2016 for facial wrinkles and folds. For this new indication, it has demonstrated results in a range of skin types, male and female subjects, and those older than age 52 years.
“The chin is the foundational anchor of the face that brings the rest of your features into balance,” Alisa Lask, general manager and vice president of the U.S. aesthetics business at Galderma, said in the release. “Consumers can now address the chin with a nonsurgical, safe option from a brand that uses cutting-edge XpresHAn technology to shape and produce long-lasting results.”
A pivotal phase 3 clinical trial showed 74% of patients had significantly improved chin projection as measured by the Galderma Chin Retrusion Scale for up to 1 year, the release said. In addition, 99% of patients reported improvement in the appearance of their chin projection at 12 weeks and 96% at up to 1 year.