Galderma (SIX: GALD) announced positive topline results from a randomized, evaluator-blinded study evaluating Restylane Volyme — known as Restylane Contour in the United States — for the correction of moderate-to-severe temple hollowing in 162 patients across six sites in China.
The study met its primary endpoint, demonstrating both the effectiveness and safety of Restylane Volyme compared with a no-treatment control, alongside high patient and investigator satisfaction rates. The results bolster Galderma's strategy to broaden the indications for its Restylane hyaluronic acid injectables portfolio in China, one of the world's fastest-growing aesthetics markets.
Among patients receiving Restylane Volyme, 94.4% showed at least a one-grade improvement in temple hollowing in both temples at Month 6 after last treatment, compared with 2.0% in the control group at the same timepoint. Blinded-evaluator responder rates, measured on the Galderma Temple Volume Deficit Scale, remained high through Month 12. Additionally, 91.3% of treated patients showed improvement on the Global Aesthetic Improvement Scale for both temples according to treating investigators through Month 12.
Patient satisfaction was consistently high throughout the study. More than 84% of patients reported satisfaction with both the natural appearance and feel of their temples through Month 12, and over 90% said they would recommend the treatment to a friend. More than 86% indicated they would undergo the treatment again, while half of participants reported being comfortable resuming social engagement within 24 hours of their initial injection.
On the safety front, Restylane Volyme was generally well tolerated. No treatment-related serious adverse events were reported, and there were no incidences of granulomas.
Temple volume loss with age can disrupt facial harmony and contribute to a tired, sunken appearance — changes that have accelerated among individuals undergoing medication-driven weight loss, a trend that has grown rapidly in recent years. Treatment options for temple hollowing in China remain limited. Restylane Volyme, which uses OBT technology to create a moderately soft and flexible gel, was previously launched in China for mid-face augmentation; this study adds a new indication.
"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," said Prof. Zhao Hongyi, study principal investigator and director of the department of plastic surgery at Beijing Hospital. "These results demonstrate that Restylane Volyme can provide effective, natural-looking correction with high levels of patient satisfaction and a robust safety profile."
Baldo Scasselatti Sforzolini, MD, PhD, global head of R&D at Galderma, said the findings represent "an important step in our strategy to expand the Restylane portfolio in China" and support the company's ambition to broaden available indications for practitioners and patients.
China is among the top markets globally for hyaluronic acid fillers, which rank among the 10 best-selling aesthetics products in the country. Galderma noted that the Restylane portfolio has accumulated more than 77 million treatments worldwide over more than three decades.
