The U.S. FDA approved Galderma’s Restylane Contour for the correction of temple hollowing in patients over the age of 21 on March 23, the dermatology company announced in a press release.
The decision follows the recent U.S. FDA approval for Restylane Lyft for the enhancement of the chin profile and previous approvals for cheek augmentation and midface contour deficiencies, helping injectors address volume loss across key structural areas and demonstrate Galderma’s ongoing commitment to deliver personalized, natural-looking outcomes.
Related: Galderma Study: Restylane + Sculptra Restore Facial Volume from Weight Loss
Galderma’s focus on the temples is a response to the medication-driven weight loss phenomenon which has increased rapidly in recent years in wake up GLP-1s. While the volume of the temples can diminish with age, contributing to a tired, sunken, and aged appearance, the process accelerates with rapid weight loss. Galderma is spearheading efforts to address these concerns.
The Restylane Contour provides a new option for increasing volume in the temples, helping restore balance for a more refreshed, youthful look. 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.
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:
- 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
- Clinical investigators rated 100% of patients as having improved from baseline at three months, with 98% at six months and 89% at 18 months
- 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
- Over 84% of patients were satisfied with their temples for a full 18 months as assessed by the FACE-Q patient-reported outcome tool
- 99% of investigators felt the results were natural looking three months after treatment
- Safety:
- All treatment-related adverse events were mild to moderate, with no serious events
