Galderma’s Restylane® Volyme™ Demonstrates High Effectiveness, Satisfaction and a Robust Safety Prof

 Galderma (SIX: GALD) today announced positive topline results from a study of Restylane Volyme for the correction of moderate-to-severe temple hollowing in 162 patients in China.1 The study met its primary endpoint, demonstrating the effectiveness and safety of Restylane Volyme versus a no-treatment control, while also achieving high patient and investigator satisfaction.1 These data further reinforce Galderma's ambition to expand its Restylane hyaluronic acid (HA) injectables portfolio in China, one of the world's fastest-growing aesthetics markets, through evidence generation that supports broader patient access and additional treatment areas.1-3

Powered by diverse NASHA®, NASHA HD™, and OBT™ technologies, Restylane offers gels with the highest firmness to the highest flexibility, enabling personalized treatments that deliver structural support, natural-looking results, and a healthy glow.1,4-8 Restylane Volyme is a moderately soft and flexible gel made with OBT that distributes within the tissue to offer natural-looking results, helping to soften temple hollowing, restore facial balance, and create a refreshed appearance.1,4,9 With a dual-layer patent-pending technique leveraging both needle and cannula, Restylane Volyme enables healthcare professionals to provide precise, customized, and safe product placement in line with each patient’s aesthetic goals10-12

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.12-14 These facial changes can be accelerated in people undergoing medication-driven weight loss, a phenomenon which has increased rapidly in recent years.12-14 Following the launch of Restylane Volyme in China for the treatment of the mid-face region, this study provides new evidence supporting its effectiveness and safety for correction of temple hollowing, in a market where there are currently limited options.1

“Temple hollowing is a common concern among patients seeking facial rejuvenation, particularly for those experiencing medication-driven weight loss, yet treatment options in China remain limited. These results demonstrate that Restylane Volyme can provide effective, natural-looking correction with high levels of patient satisfaction and a robust safety profile. As demand for individualized aesthetic treatments continues to grow in China, expanding the range of evidence-based solutions available will be increasingly important.”

PROF. ZHAO HONGYI
STUDY PRINCIPAL INVESTIGATOR,
DIRECTOR & CHIEF OF THE DEPARTMENT OF PLASTIC SURGERY, BEIJING HOSPITAL, CHINA

In this randomized, evaluator-blinded study, 162 adults were recruited across six sites in China and were split 2:1 into two groups; the Restylane Volyme treatment group or the no treatment control group.1 Results showed that for patients in the Restylane Volyme group:

• Strong effectiveness
  • 94.4% of patients demonstrated at least 1-grade improvement in temple hollowing, from baseline, in both temples at Month 6 after last treatment, compared to just 2.0% in the control group at Month 6 after baseline.1
  • Blinded-evaluator Galderma Temple Volume Deficit Scale responder rates remained high through Month 121
  • 91.3% of patients showed improvement on the Global Aesthetic Improvement Scale for both temples through Month 12, according to the treating investigator1
• High satisfaction
• Patient satisfaction was high at Month 3 and remained consistently high, with more than 84% of patients satisfied with both the natural look and natural feel of their temples through Month 121
• More than 90% said they would recommend the treatment to a friend, and over 86% would have the treatment again1
• Half of the participants felt comfortable returning to social engagement within 24 hours after initial treatment1
• Restylane Volyme was generally well tolerated, with no treatment-related serious adverse events and no granulomas1
• Robust safety

“These positive topline results further strengthen the clinical evidence supporting Restylane Volyme and mark an important step in our strategy to expand the Restylane portfolio in China. As one of the world’s fastest-growing aesthetics markets, China presents a significant opportunity to address evolving patient needs with science-backed, differentiated solutions. This study supports our ambition to broaden the indications available to practitioners and patients, while reinforcing Galderma’s leadership in Injectable Aesthetics through continued investment in innovation and clinical research.”

BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
GLOBAL HEAD OF R&D
GALDERMA

With over 30 years of innovation and more than 77 million treatments administered worldwide, the Restylane portfolio offers a versatile range of HA gels that remain highly relevant in responding to today’s most significant aesthetic trends and needs.15-16 China is one of the fastest growing aesthetics markets worldwide and HA fillers are among the top 10 most-sold aesthetics products.2,3 This study highlights Galderma’s commitment to expand the availability of its Restylane portfolio to more patients and practitioners in China and exemplifies its continuing expansion in a growing and strategically significant market.

About the Restylane portfolio
Restylane HA treatments are designed differently to go beyond volumizing for natural-looking results.17-19 Our HA is minimally modified and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.5,20,21 Powered by NASHA®, NASHA HD™, and OBT™ technologies, Restylane offers gels with the highest firmness to the highest flexibility, enabling personalized treatments that deliver structural support, natural-looking results, and a healthy glow.4,6-8 Trusted for almost three decades, our HA gels work in sync with your skin for 100% natural-looking results. 18,22,23 Approved indications vary by market.

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. 43CH2401
2. Deloitte. China Aesthetic Medicine Outlook Report. Accessed September 2026. Available online.
3. Grand View Horizon. China Aesthetic Medicine Market Size & Outlook, 2026-2033. Accessed September 2026. Available online
4. Galderma. Data on file. MA-56724. 2023. Global rheology data (xStrain and G´ including Restylane SHAYPE).
5. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
6. Nikolis A, 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. doi: 10.36849/JDD.8145.
7. 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. doi: 10.36849/JDD.7648.
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10. Restylane® Volyme. IFU. Available online. Accessed September 2026
11. Galderma Laboratories, L.P. Data on file. MA-63365 Study Report. 2025
12. Galderma. Data on file. Restylane Contour temple investigator closeout meeting executive summary. 2025
13. Humphrey CD & Lawrence AC. Implications of Ozempic and other GLP-1 receptor agonists for facial plastic surgeons. Facial Plast Surg, 2023;39:719-73. doi: 10.1055/a-2148-6321
14. Tay JQ. Ozempic face: A new challenge for facial plastic surgeons. JPRAS.2023;81-97-98. doi: 10.1016/j.bjps.2023.04.057
15. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated.
16. Galderma. Data on file. MA-55607. Restylane® 27 years data publications analysis
17. Restylane® EU Instructions for Use. July 2026.
18. 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.
19. Galderma. Data on file. MA-48544 Subject satisfaction (GAIS) – NASHA and OBT Fillers. 2021.
20. Kablik J, et al. Comparative physical properties of HA dermal fillers. Dermatol Surg. 2009; 35, 302–312. doi: 10.1111/j.1524-4725.2008.01046.x.
21. Edsman K, et al. Gel properties of hyaluronic acid dermal fillers. Dermatol Surg. 2012;38:1170–1179. doi: 10.1111/j.1524-4725.2012.02472.x.
22. Solish N, et al. Dynamics of hyaluronic acid fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738-746. doi: 10.1111/jocd.12961.
23. Philipp‐Dormston WG, et al. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7):1600-1606. doi: 10.1111/jocd.1320