Galderma Receives FDA Approval for Restylane® Lyft™ for Chin Profile Enhancement 

The U.S. Food and Drug Administration (FDA) recently approved Restylane Lyft with Lidocaine for augmentation of the chin region to improve the chin profile in patients aged 21 and older with mild-to-moderate chin retrusion.

Restylane Lyft, a versatile hyaluronic acid (HA) injectable, is already approved for the midface, facial folds and wrinkles (such as nasolabial folds), and the back of the hands. This new indication further expands its use for aesthetic facial contouring.

Structure and Support

The Restylane portfolio includes HA injectables ranging from softer, more flexible formulations to firmer gels.  These substances are used to fill facial wrinkles, enhance facial volume, and improve skin elasticity, providing a youthful appearance and empowering practitioners to deliver personalized aesthetic outcomes. Restylane Lyft delivers one of the firmer gels in the line, with minimal modification and a high G-prime, closely resembling the skin’s natural HA. This firmness provides support and projection, allowing practitioners to improve chin contour and create a more balanced lower-face profile.

Clinical Findings

The approval is based on results from a pivotal clinical trial demonstrating Restylane Lyft’s safety and effectiveness in enhancing chin projection. Improvements were seen at three months after injection and were sustained for most patients through 12 months.

Key outcomes included:

  1. High rates of aesthetic improvement: At Month 3, 99.1% of investigators and 94.4% of subjects reported visible improvement. At Month 12, 95.5% of investigators and 89% of subjects continued to report positive outcomes.
  2. Strong patient satisfaction: A high proportion of patients agreed or strongly agreed that Restylane Lyft created natural-looking projection, improved lower-face appearance, and provided a smooth transition from chin to jawline, reaching satisfaction rates up to 86.3%.
  3. Favorable safety profile: Restylane Lyft was well tolerated with no unexpected or serious product-related adverse events.

Flexibility and Precision

The trial results and product performance support Restylane Lyft as a safe and effective option for enhancing the chin and addressing facial harmony goals for patients.

“This approval reinforces our commitment to advancing our Injectable Aesthetics portfolio to meet the diverse needs of patients,” said Bill Andriopoulos, PhD, Galderma U.S.’s vice president of medical affairs. “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.”

Safety Concerns

The most common side effects reported in the study included bruising, nodules, exfoliation, hemorrhage, edema, papules, and redness. Patients also reported pain, tenderness, swelling, itching, and lumps or bumps.

Because Restylane Lyft with Lidocaine contains trace amounts of gram-positive bacterial protein, it is contraindicated for patients with related allergies. It should also not be used in individuals with severe allergies requiring in-hospital treatment, bleeding disorders, hypersensitivity to amide-type anesthetics (such as lidocaine), or by those who are pregnant or breastfeeding.

Concluding Remarks

Atlanta dermatologist Alia S. Brown, MD, FAAD, noted that Restylane Lyft is already a familiar and trusted product with a long record of global safety.

“It’s already a trusted product in my clinic, supported by my own experience and over two decades of global safety data,” she said. “So, I’m pleased to now be able to also offer patients its benefits in the chin.”

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