Galderma announced the U.S. Food and Drug Administration (FDA) approved Restylane Eyelight, a hyalauronic acid (HA) dermal filler, for the treatment of undereye hollows, also known as dark shadows, in adults over the age of 21. According to a press release from the company, Restylane Eyelight is the first and only product in the U.S. formulated with NASHA Technology for volume loss under the eyes, giving patients natural-looking results.

“Restylane Eyelight is an exciting new treatment option for patients,” said Bill Andriopoulos, PhD, vice president for medical affairs at Galderma US. “Formulated with NASHA Technology, this filler is close to the body’s natural hyaluronic acid with minimal crosslinking and produces a firm gel texture (or ‘supportive gel’) that is resistant to water absorption, which makes Restylane Eyelight a safe, natural-looking solution for volume loss under the eyes.”

Carolyn Jacob, MD, a board-certified dermatologist and medical director at Chicago Cosmetic Surgery and Dermatology, who was a lead investigator in the clinical trial of Restylane Eyesight and is a paid Galderma consultant, said, “Many of my patients seek treatment for hollows under the eyes, and topical products such as creams, concealers and undereye masks just aren’t able to solve the problem and provide the long-lasting results they are seeking. I’m pleased to see that Restylane Eyelight offers a safe, effective and natural-looking outcome that enables my patients to achieve their aesthetic undereye goals, with results that last up to 18 months with optimal treatment.”

Phase 3 Study

According to Galderma, this FDA approval is supported by efficacy and safety data from a randomized, evaluator-blinded, parallel group, no-treatment controlled, multi-center Phase 3 study to evaluate the effectiveness and safety of Restylane Eyelight for correction of volume loss under the eyes.

Lack of volume and volume loss in the undereye region can create shadows and emphasize dark circles, leading to the appearance of tiredness and/or aging. In the Phase 3 study, 87% of patients/clinical trial subject had reduced undereye hollowness at 3 months (at least 1-grade improvement on the Galderma Infraorbital hollows scale), and Restylane Eyelight was found to be well tolerated under the eyes. At 3 months, 92% of patients were pleased with their results, and 84% were still pleased through 1 year. According to the company, the study also yielded high satisfaction, with 93% of patients expressing interest in receiving treatment again after 12 months. 

Furthermore, most patients (87%) did not experience adverse events related to treatment with Restylane Eyelight. The most commonly observed side effects for undereye injection are swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site. Most adverse events were mild in severity (75%) and none were severe, according to the company’s press release. There was no incidence of Tyndall effect (blue discoloration) after treatment with Restylane Eyelight.

Restylane Eyelight HA dermal filler reportedly will be available in aesthetic practice locations across the United States over the next several months. 

In April, Galderma’s Sculptra, an injectable poly-L-lactic acid (PLLA-SCA) collagen stimulator, received FDA approval for the correction of fine lines and wrinkles in the cheek area.