FDA OK’s Galderma’s Restylan Defyne for Chin Work

FDA has approved Galderma’s Restylan Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21. The hyaluronic acid dermal filler was first approved in 2016 for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over age 21.

Galderma says the device is manufactured using the company’s manufacturing process, XpresHAn Technology, to create a smooth, injectable gel that “integrates into the skin for natural, dynamic movement.” Approval was based on data demonstrating that the product has a proven safety and tolerability profile and was well-tolerated for chin enhancement, it says. Results from a pivotal Phase 3 clinical trial showed that 74% of patients experienced significantly improved chin projection for up to one year.