FDA Approves Restylane Contour for Temple Hollowing Correction

Galderma announced that the U.S. Food and Drug Administration (FDA) has approved Restylane® Contour™ for the correction of temple hollowing in patients aged 21 years and older, expanding its indications beyond cheek augmentation and midface contour deficiencies. The approval enables clinicians to address volume loss in an additional structural facial area using the same hyaluronic acid filler platform.

Temple volume loss, which can occur with aging or weight changes, may contribute to a hollowed or fatigued appearance. According to the company, the newly approved indication provides an option to restore volume and improve facial balance. Restylane Contour utilizes OBT™/XpresHAn™ technology, designed to integrate into tissue while maintaining flexibility and support for natural-looking outcomes. The product may be administered using a dual-layer, patent-pending injection technique involving both needle and cannula to support tailored placement.

“Despite the temples playing an important role in maintaining a youthful, balanced appearance, they are often overlooked as an aesthetic treatment area. I am pleased to have a new treatment option that I can recommend to my patients to help restore youthful proportions by effectively improving temple hollowing. This latest approval for Restylane Contour, offering dual-depth injection flexibility, will help me deliver harmonious, natural-looking results across the midface and temples that suit my patients’ unique features,” said Mark Nestor, MD, PhD.

The press release said the approval was supported by clinical trial data demonstrating improved temple hollowing compared with no treatment at 3 months, with durability of effect up to 18 months. At 3 months, 91% of patients were considered treatment responders, with more than 85% maintaining response through 18 months. Investigator assessments indicated 100% improvement at 3 months, decreasing to 89% at 18 months. Patient-reported outcomes showed that over 84% remained satisfied at 18 months, and more than 70% reported looking younger and more refreshed. All treatment-related adverse events were reported as mild to moderate, with no serious events.

“This approval for Restylane Contour with an innovative injection technique is yet another demonstration of our ongoing commitment to ensuring our trusted products deliver what healthcare professionals need to meet diverse aesthetic goals,” said Bill Andriopoulos, PhD, Head of Global Medical Affairs at Galderma. “Restylane Contour for temples aligns with this rising demand, providing a natural and authentic way to restore harmony.”