Galderma announced that the U.S. Food and Drug Administration (FDA) has approved Restylane Lyft with Lidocaine for augmentation of the chin region to improve the chin profile in patients over the age of 21 with mild-to-moderate chin retrusion. Restylane Lyft is a versatile HA injectable with over 20 years of worldwide safety data, which is also approved to treat the midface, facial folds and wrinkles (such as nasolabial folds) and back of hands.
The approval is based on results from a pivotal clinical trial, confirming the clinical performance and safety of Restylane Lyft for chin enhancement. The primary endpoint of the study was met, demonstrating its safety and effectiveness in improving chin projection three months after initial injection, with improvement sustained in the majority of patients through 12 months. Additional results showed:
- Global aesthetic improvement, as assessed by both patients and investigators, remained consistently high throughout the study. At Month 3, 99.1 percent of investigators and 94.4 percent of subjects reported visible improvement. These results were maintained at Month 12, with 95.5 percent of investigators and 89.0 percent of patients continuing to report positive outcomes.
- At the end of the study (Month 12), a high proportion of patients agreed or strongly agreed that Restylane Lyft delivered natural-looking chin projection, improved the appearance of the lower face, and provided a smooth transition from chin to jawline, with satisfaction rates up to 86.3 percent.
- Restylane Lyft was well tolerated, with no unexpected or serious adverse events related to the product reported during the study, reinforcing its favorable safety profile.
Regulatory applications for Restylane Lyft for use on the chin will continue to be submitted and assessed by additional authorities globally. Galderma is working to bring this expanded indication to as many countries as possible.