FDA Approves Restylane Lyft for Chin Enhancement, Expanding Hyaluronic Acid Filler Applications
核心洞察
The U.S. FDA has approved Restylane Lyft (搜索) with Lidocaine for chin augmentation in patients over 21 with mild-to-moderate chin retrusion (搜索), making it the only hyaluronic acid injectable approved for multiple facial areas including midface, hands, and now chin.
Clinical trial results demonstrated 99.1% of investigators and 94.5% of patients reported visible improvement at three months, with sustained benefits through 12 months and satisfaction rates reaching 86.3%.
The approval is supported by over 20 years of worldwide safety data and represents an expansion of Galderma's Injectable Aesthetics portfolio, which has delivered over 77 million treatments globally.
The U.S. Food and Drug Administration has approved Restylane Lyft (搜索) with Lidocaine for augmentation of the chin region to improve chin profile in patients over 21 with mild-to-moderate chin retrusion (搜索), Galderma announced. This approval makes Restylane Lyft the only hyaluronic acid injectable approved to treat the midface, facial folds and wrinkles, back of hands, and now the chin.
The approval is based on results from a pivotal clinical trial that met its primary endpoint, demonstrating safety and effectiveness in improving chin projection three months after initial injection, with improvement sustained in the majority of patients through 12 months.
Clinical Trial Results Show Strong Efficacy
The clinical study revealed consistently high global aesthetic improvement rates throughout the 12-month observation period. At Month 3, 99.1% of investigators and 94.5% of subjects reported visible improvement. These positive outcomes were maintained at Month 12, with 95.4% of investigators and 89.0% of patients continuing to report improvement.
Patient satisfaction remained high throughout the study duration. At the end of the 12-month study period, a high proportion of patients agreed or strongly agreed that Restylane Lyft (搜索) delivered natural-looking chin projection, improved the appearance of the lower face, and provided a smooth transition from chin to jawline, with satisfaction rates reaching up to 86.3%.
Safety Profile Reinforced
The study reinforced Restylane Lyft (搜索)'s favorable safety profile, with no unexpected or serious adverse events related to the product reported during the clinical trial. The most common side effects reported in the chin augmentation study included bruising, nodules, exfoliation, hemorrhage, edema, papules and redness. Patients also reported pain, tenderness, swelling, itching, and lumps/bumps.
"The chin plays a vital role in overall facial harmony. Restylane Lyft (搜索) offers a safe and effective way to enhance this area, helping to bring balance and definition to the face," said Dr. Alia S. Brown, a cosmetic dermatologist at Atlanta Biomedical Clinical Research and Georgia Dermatology Partners.
Technology and Product Characteristics
Restylane Lyft (搜索) is developed with NASHA technology, featuring a firmer gel with minimal modification that closely resembles the skin's natural hyaluronic acid. 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.
The product is backed by over 20 years of worldwide safety data and is part of Galderma's Restylane portfolio, which has delivered over 77 million treatments globally. The portfolio offers a versatile range of hyaluronic acid injectables, from soft and flexible to firm gel formulations.
Market Position and Future Plans
"This approval reinforces our commitment to advancing our Injectable Aesthetics portfolio – the broadest on the market – to meet the diverse needs of patients," said Dr. Bill Andriopoulos, Vice President of Medical Affairs at Galderma U.S. "By expanding how innovations like Restylane Lyft (搜索) can be used, we aim to empower aesthetic practitioners to achieve their patients' unique aesthetic goals with enhanced flexibility and precision."
Galderma plans to submit regulatory applications for Restylane Lyft (搜索) for chin use to additional authorities globally, working to bring this expanded indication to as many countries as possible.
Safety Considerations
Restylane Lyft (搜索) with Lidocaine is contraindicated for patients with allergies to gram-positive bacterial protein or severe allergies requiring hospitalization. The product should not be used by people with bleeding disorders, hypersensitivity to amide-type local anesthetics such as lidocaine, or by pregnant or breastfeeding women.
Healthcare providers are advised to use caution in patients recently treated with anticoagulants or platelet inhibitors to avoid bleeding and bruising. The product is only available through licensed practitioners.