Pivotal trial data showed sustained improvement in chin projection and high patient and investigator satisfaction through 12 months.
The US Food and Drug Administration (FDA) has approved Galderma’s 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. The hyaluronic acid (HA) injectable is also approved to treat the midface, facial folds and wrinkles, and back of hands.
Restylane Lyft, developed with NASHA technology, has a firmer gel with minimal modification, closely resembling the skin’s natural HA. With its high G-prime, Restylane Lyft is specifically designed to provide structure and support, enabling it to enhance the chin for a balanced profile.
“By expanding how innovations like Restylane Lyft can be used, we aim to empower aesthetic practitioners to achieve their patients’ unique aesthetic goals with enhanced flexibility and precision,” says Bill Andriopoulos, PhD, vice president of medical affairs at Galderma US.
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 three, 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%
- 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, FAAD, Atlanta Biomedical Clinical Research and Georgia Dermatology Partners cosmetic dermatologist.
Galderma notes in a release that regulatory applications for Restylane Lyft for use on the chin will continue to be submitted and assessed by additional authorities globally.
Photo caption: Restylane Lyft
Photo credit: Galderma
