Galderma Receives U.S. FDA Approval for Restylane® Lyft™ for the Enhancement of the Chin Profile

(BUSINESS WIRE) -- Galderma (SIX: GALD), 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.² 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.^2,3,4

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.^5-8 Restylane Lyft, developed with NASHA^® technology, has a firmer gel with minimal modification, closely resembling the skin’s natural HA.^9,10 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.^2,5,11

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

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.

Restylane Lyft with Lidocaine is only available through a licensed practitioner. Complete Instructions for Use are available here.

About the Restylane portfolio

Restylane hyaluronic acid (HA) injectables are designed differently to go beyond volumizing for natural-looking results.^1,12-14 Our HA is exceptionally pure and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^9,10,15 Restylane’s unique technologies, NASHA HD^™, NASHA and OBT^™/XpresHAn^™ are meaningfully designed to mimic the diverse range of facial structures and skin layers.^12-14 With the highest G’ and highest flexibility, Restylane can provide structural support, natural expressions and a healthy glow.^7,13,15-18 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural looking results.^12,19,20

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Galderma. Data on file. MA-60800. 43USCH2208 R Lyft Chin US Clinical Study Report.

2. Restylane^® Lyft. Instructions for Use. Available online. Galderma Laboratories, L.P., 2025.

3. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.

4. Galderma. Data on file. MA-55607. Restylane^® 27 years data publications analysis.

5. Galderma Data on file. MA-56724. X-strain and G’ including Shaype.

6. Nikolis A, Humphrey S, Rivers JK, et al. Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion. J Drugs Dermatol. 2024;23(4):255–261.

7. Öhrlund Å, Winlöf P, Bromée T, et al. Differentiation of NASHA and OBT Hyaluronic Acid Gels According to Strength, Flexibility, and Associated Clinical Significance. J Drugs Dermatol. 2024;23(1):1332–1336.

8. Belmontesi M, De Angelis F, Di Gregorio C, et al. Injectable Non-Animal Stabilized Hyaluronic Acid as a Skin Quality Booster: An Expert Panel Consensus. J Drugs Dermatol. 2018;17(1):83–88.

9. Edsman K, Nord LI, Öhrlund Å, et al. Gel Properties of Hyaluronic Acid Dermal Fillers. Dermatol Surg. 2012;38:1170–1179.

10. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.

11. Data on file. MA-34483. Study Report. Galderma Laboratories, L.P., 2021.

12. Di Gregorio C, Avelar L, Lam S, et al. 25+ years of experience with the Restylane portfolio of injectable HA fillers for facial aesthetic treatment. E-poster presented at AMWC; March 27-29, 2024; Monaco.

13. Nikolis A, Enright KM, Lazarova D, et al. The role of clinical examination in midface volume correction using hyaluronic acid fillers: should patients be stratified by skin thickness? Aesthet Surg J Open Forum. 2020; 2(1):1–12.

14. Galderma. Data on file. Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021.

15. Kablik J, Monheit GD, Yu LP, et al. Comparative physical properties of HA dermal fillers. Dermatol Surg. 2009; 35, 302–312.

16. Bromée T, Öhrlund Å, Winlöf P, et al. A new hyaluronic acid injectable, HASHA, sets new G-prime standards. Abstract presented at AMWC 2025; Mar 27-29, 2025; Monaco.

17. Narins RS, Brandt FS, Dayan SH, et al. Persistence of nasolabial fold correction with a HA dermal filler with retreatment: results of an 18-month extension study. Dermatol Surg. 2011;37: 644-650.

18. Talarico S, Meski AP, Buratini L. et al. High patient satisfaction of a HA filler producing enduring full-facial volume restoration: an 18-month open multicenter study. Dermatol Surg. 2015;41: 1361–1369.

19. Solish N, Bertucci V, Percec I, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3): 738-746.

20. Philipp‐Dormston WG, Schuster B, and Podda M. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7): 1600-1606.

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