Galderma Receives U.S. FDA Approval for Restylane® Contour™ for the Correction of Temple Hollowing

(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the U.S. FDA has approved Restylane Contour for the correction of temple hollowing in patients over the age of 21.^1,2 This builds on its previous approvals for cheek augmentation and midface contour deficiencies, helping injectors address volume loss across key structural areas.^1-3

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With the broadest Injectable Aesthetics portfolio in the industry, this follows the recent U.S. approval of Restylane Lyft for augmentation of the chin region, adding to its indications to treat the midface, facial folds and wrinkles, back of hands, and the chin.^4,5 Together, these approvals demonstrate Galderma’s ongoing commitment to evolving the versatile Restylane portfolio to deliver personalized, natural-looking outcomes that meet diverse patient needs.^1,4,6,7

The volume of the temples can diminish with age, which can disrupt facial balance and harmony, and contribute to a tired, sunken, and aged appearance.^3,8,9 These facial changes can be accelerated in people undergoing medication-driven weight loss, a phenomenon which has increased rapidly in recent years resulting in a growing area of aesthetic need.^3,8,9 Galderma is spearheading efforts to address these concerns, including with this latest approval for Restylane Contour, which provides a new option for increasing volume in the temples to help restore balance for a more refreshed, youthful look.^1-3 With a dual-layer patent-pending technique leveraging both needle and cannula, Restylane Contour enables healthcare professionals to provide precise, customized, and safe product placement in line with each patient’s aesthetic goals.^1-3 Restylane Contour is powered by OBT™/XpresHAn™ technology, which integrates into the skin and balances support and flexibility, to provide long-lasting, natural-looking results that move with facial expressions.^1-3,6

The approval is based on clinical results showing that Restylane Contour improved temple hollowing compared with no treatment at three months, with results lasting for up to 18 months, and high investigator and patient (clinical trial participant) satisfaction:^1,2

• Efficacy:
  • 91% of patients were considered treatment responders at three months and over 85% were considered treatment responders up to 18 months after initial treatment^1,2
  • Clinical investigators rated 100% of patients as having improved from baseline at three months, with 98% at six months and 89% at 18 months^1,2
• Patient satisfaction:
  • Over 70% of patients felt they looked younger, less tired, and more refreshed 18 months after treatment, and 85% felt their temples looked natural at Month 18^1,2
  • Over 84% of patients were satisfied with their temples for a full 18 months as assessed by the FACE-Q patient-reported outcome tool^1,2
  • 99% of investigators felt the results were natural looking three months after treatment^1,2
• Safety:
  • All treatment-related adverse events were mild to moderate, with no serious events^1,2

With over 30 years of innovation and more than 77 million treatments administered worldwide, Restylane remains highly relevant in addressing some of today’s most significant aesthetic trends and needs, from changes following medication-driven weight loss to growing concerns related to menopause and skin health.^10-14 As patient expectations shift toward more effortless, always-on rejuvenation, Galderma’s new ‘Wake Up To Restylane’ campaign positions Restylane as an everyday natural beauty ally for the face and body, highlighting Galderma’s commitment to meeting emerging needs. Focused on the growing desire for natural, authentic results, the campaign underscores Restylane’s ability to deliver personalized outcomes that move naturally with expression, helping people look refreshed and feel confident in their skin.^6,7,14,15

*Restylane Contour is known as Restylane Volyme™ in countries outside of the U.S.
**Spokesperson is a paid Galderma consultant

Important safety information
Restylane Contour is indicated for cheek augmentation and the correction of midface contour deficiencies in patients over the age of 21. Restylane Contour is also indicated for correction of temple hollowing in patients over the age of 21.

Restylane Contour 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. Restylane Contour 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 include bruising, redness, swelling, pain, tenderness, and itching at the injection site. Use at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. The safety or effectiveness of treatment in areas other than the cheek, midface or temple has not been established in controlled clinical studies.

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 Contour is only available through a licensed practitioner. Complete Instructions for Use are available at www.RestylaneUSA.com.

About the Restylane portfolio
Restylane hyaluronic acid injectables are designed differently to go beyond volumizing for natural-looking results.^1,14,16 Our hyaluronic acid is exceptionally pure and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^17-19 Restylane’s unique technologies, NASHA HD™, NASHA™ and OBT™/XpresHAn™, are meaningfully designed to mimic the diverse range of facial structures and skin layers.^5,14,16,20 With the highest G’ and highest flexibility, Restylane can provide structural support, natural expressions and a healthy glow.^6,16,19-23 Trusted for almost three decades, our hyaluronic acid gels work in sync with your skin for natural looking results.^14,24,25

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. Restylane^® Contour™. Instructions for use. Available online. Accessed March 2026
2. Galderma Laboratories, L.P. Data on file. MA-63365 Study Report. 2025
3. Galderma. Data on file. Restylane Contour temple investigator closeout meeting executive summary. 2025
4. Restylane^® Lyft™. Instructions for Use. Available online. Accessed March 2026
5. Galderma Data on file. MA-56724. X-strain and G’ including Shaype
6. Öhrlund Å, 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
7. Belmontesi M, 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
8. Humphrey CD & Lawrence AC. Implications of Ozempic and other GLP-1 receptor agonists for facial plastic surgeons. Facial Plast Surg. 2023;39:719- 72
9. Qin J. Ozempic face: A new challenge for facial plastic surgeons. JPRAS. 2023;81:97-98
10. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated
11. Galderma. Data on file. MA-55607. Restylane^® 27 years data publications analysis
12. Fabi SG, et al. The potential role of biostimulators/dermal fillers to address menopause-related skin conditions. Poster presented at IMCAS 2026; January 29-31, 2026; France
13. Lorenc ZP, et al. Synergistic efficacy and safety of poly-L-lactic acid biostimulator and hyaluronic acid filler for facial fullness post weight loss due to glucagon-like peptide-1 receptor agonist medication. Presented at the ASDS 2025 Annual Meeting; November 13-16; United States
14. Di Gregorio C, 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
15. Galderma. Data on file. Global report: Aesthetics treatments and hyaluronic acid injectables. Consumers & HCPs. 2025
16. Galderma. Data on file. MA-48544 Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021
17. Edsman K, et al. Gel properties of hyaluronic acid dermal fillers. Dermatol Surg. 2012;38:1170–1179.
18. Galderma. Data on file. MA-58650. Degree of modification of HA fillers
19. Kablik J, et al. Comparative physical properties of HA dermal fillers. Dermatol Surg. 2009; 35, 302–312
20. Nikolis A, 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
21. Bromée T, et al. A new hyaluronic acid injectable, HASHA, sets new G-prime standards. Abstract presented at AMWC 2025; Mar 27-29, 2025; Monaco
22. Narins RS, 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
23. Talarico S, 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
24. Solish N, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3): 738-746
25. Philip-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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