The expanded indication is based on clinical data showing high responder rates and results lasting up to 18 months, with no serious adverse events reported.
The US Food and Drug Administration (FDA) has approved Restylane Contour for the correction of temple hollowing in patients over the age of 21, expanding its use beyond cheek augmentation and midface contour deficiencies.
The approval adds to existing indications within the Restylane portfolio, including the recent FDA approval of Restylane Lyft for chin augmentation. The products are used to address volume loss across different areas of the face.
Temple volume can decrease with age, which may affect facial balance and contribute to a sunken or tired appearance. The company noted that these changes may also be seen in patients undergoing medication-driven weight loss.
Restylane Contour is designed to restore volume in the temple area using a dual-layer injection technique with either a needle or cannula. The product uses XpresHAn technology, which is intended to integrate into the skin while maintaining flexibility.
“Despite the temples playing an important role in maintaining a youthful, balanced appearance, they are often overlooked as an aesthetic treatment area,” says Mark Nestor, MD, PhD, a board-certified dermatologist and dermatologic surgeon, in a release. “I’m 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.”
Clinical Data Shows Improvement in Temple Hollowing
The FDA decision was supported by clinical data showing improvement in temple hollowing compared with no treatment at three months, with results lasting up to 18 months. According to the company, 91% of patients were considered treatment responders at three months, with more than 85% maintaining response through 18 months. Investigators reported improvement in all patients at three months, with 89% still improved at 18 months.
Patient-reported outcomes showed that more than 70% of participants felt they looked younger, less tired, and more refreshed at 18 months, while 85% said their results appeared natural. More than 84% reported satisfaction with their temples over the same period.
All treatment-related adverse events were reported as mild to moderate, with no serious events observed in the study.
“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,” says Bill Andriopoulos, PhD, head of global medical affairs at Galderma, in a release. “For example, as rates of medication-driven weight loss expand, we’re seeing greater need for treatments that can address associated facial volume changes. Restylane Contour for temples aligns with this rising demand, providing a natural and authentic way to restore harmony.”
Restylane products have been used in more than 77 million treatments worldwide, according to the company.
Photo caption: Restylane Contour
Photo credit: Galderma
