The U.S. Food and Drug Administration (FDA) has approved Galderma’s Restylane Lyft with Lidocaine for augmentation of the chin region in patients aged 21 and up with mild-to-moderate chin retrusion.
Restylane Lyft is also approved to treat the midface, facial folds and wrinkles (such as nasolabial folds), and back of hands. The filler, developed with NASHA technology, has a firmer gel with minimal modification, closely resembling the skin’s natural hyaluronic acid. With its high G-prime, Restylane Lyft is specifically designed to provide structure and support.
The approval is based on results from a pivotal clinical trial. 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% of investigators and 94.4% of subjects reported visible improvement. These results were maintained at Month 12, with 95.5% of investigators and 89.0% 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%.
In addition, 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
“The chin plays a vital role in overall facial harmony. Restylane Lyft offers a safe and effective way to enhance this area, helping to bring balance and definition to the face,” says Alia S. Brown, MD, a Cosmetic Dermatologist at the Atlanta Biomedical Clinical Research Center and Georgia Dermatology Partners in Snellville, GA. “It’s already a trusted product in my clinic, supported by my own experience and over two decades of global safety data, so I’m pleased to now be able to also offer patients its benefits in the chin.”
