Galderma, the pure-play dermatology category leader, today announced that the United States (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 Restylane portfolio offers a versatile range of HA injectables, from soft and flexible to firm gel formulations, empowering practitioners to deliver personalized aesthetic outcomes. 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 (a measure of firmness), Restylane Lyft is specifically designed to provide structure and support, enabling it to enhance the chin for a balanced profile.
“This approval reinforces our commitment to advancing our Injectable Aesthetics portfolio – the broadest on the market – to meet the diverse needs of patients. 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.” Bill Andriopoulos, Phd, Vice President of Medical Affairs, Galderma U.S.
The approval is based on results from a pivotal clinical trial, confirming the clinical performance and safety of Restylane Lyft for chin enhancement.1,2 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%
- 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. 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.” Alia S. Brown, M.D. Faad, Atlanta Biomedical Clinical Research and Georgia Dermatology Partners, Cosmetic Dermatologist
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.
