“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.1 Additional results showed:[1]

·Global aesthetic improvement, as assessed by both patients and investigators, remained consistently high throughout the study. At Month 3, 99.1% of investigators and 94.5% of subjects reported visible improvement. These results were maintained at Month 12, with 95.4% 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.

IMPORTANT SAFETY INFORMATION

Restylane Lyft with Lidocaine is indicated for deep implantation into the facial tissue for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss in patients over the age of 21. Restylane Lyft with Lidocaine is also indicated for injection into the mid-to-deep dermis (subcutaneous and/or supraperiosteal) 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 with Lidocaine contains traces of gram-positive bacterial protein and is contraindicated for patients with allergies to such material or for patients with severe allergies that have required in-hospital treatment. This product should not be used by people with bleeding disorders, with hypersensitivity to amide-type local anesthetics, such as lidocaine, or by women who are pregnant or breastfeeding.

The most common side effects reported in the clinical study to support approval of augmentation of the chin region included bruising, nodules, exfoliation, hemorrhage, edema, papules and redness. Patients also reported pain, tenderness, swelling, itching, and lumps/bumps.

Delayed-onset inflammation near the site of dermal filler injections is one of the known adverse events associated with dermal fillers, and cases have been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, superficial necrosis, and scarring at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising.