Restylane Contour, a hyaluronic acid injectable dermal filler, has received FDA approval for the “correction of temple hollowing” in patients older than age 21, according to an announcement today by the manufacturer, Galderma. The approval expands the product’s use beyond previously approved indications for cheek augmentation and midface contour loss.

The latest approval is based on clinical data that indicate Restylane Contour “delivers natural-looking results lasting for up to 18 months and high patient satisfaction,” in these key structural areas, the company states in its press release.

The data include the finding that 91% of patients were considered responders at 3 months and more than 85% were considered treatment responders up to 18 months after the start of treatment, according to the company.

Investigators reported that 100% of patients improved from baseline at 3 months, with 98% improving at 6 months and 89% at 18 months. Additionally, “more than 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,” the company states. More than 84% of patients were satisfied with their temples for 18 months as assessed by the FACE-Q patient-reported questionnaire; 99% of investigators felt the results looked natural 3 months after treatment.

Weight-Loss Drugs Boost the Need

Temple volume can drop with age, which can alter facial balance and reflect a tired, sunken, and aged appearance, changes that “can be accelerated in people undergoing medication-driven weight loss, a phenomenon which has increased rapidly in recent years resulting in a growing area of aesthetic need,” the company adds. According to KFF, 18% of US adults have tried a GLP-1 drug to lose weight, or to treat diabetes or heart disease, and 12% currently use them.

Potential Side Effects

The most common side effects of Restylane Contour include bruising, redness, swelling, pain and itching at the injection site, and treatment should be delayed in areas of the skin with skin sores, pimples, rashes, hives, cysts, or infections until healing is complete, according to the product’s safety information. In addition, serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, superficial necrosis, and injection-site scarring, according to the company.

Safety information also noted that Restylane Contour contains traces of gram-positive bacterial protein and is contraindicated for patients with allergies to such protein or for patients with severe allergies who have required in-hospital treatment. The treatment should not be used by people with bleeding disorders or hypersensitivity to amide-type local anesthetics, such as lidocaine, or by women who are pregnant or breastfeeding.

Delayed-onset inflammation near the injection site is one of the known adverse events associated with dermal fillers. Cases have been reported at the dermal filler treatment site after viral or bacterial illnesses or infections, vaccinations, or dental procedures, but typically, “the reported inflammation was responsive to treatment or resolved on its own,” the company said.

Marcia Frellick is a Chicago-based, independent healthcare journalist and a regular contributor to Medscape.