FDA Nod for Galderma's Restylane Eyelight

Restylane Eyelight is a hyaluronic acid (HA) dermal filler for the correction of undereye hollowing, in adults over the age of 21.

The U.S. Food and Drug Administration (FDA) approved Restylane Eyelight, a hyaluronic acid (HA) dermal filler for the correction of undereye hollowing, in adults over the age of 21.

Restylane Eyelight  is formulated with NASHA Technology, which has a firm gel texture resistant to water absorption and is close to the naturally occurring HA found in skin with minimal cross-linking. This technology is ideal for undereyes because it, minimizes swelling effects to treat tired-looking eyes.

 The approval is supported by data from a randomized, evaluator-blinded, parallel-group, no-treatment controlled, multi-center Phase 3 study, which revealed the following:

• 94% of patients would recommend Restylane Eyelight treatment to a friend when asked 12 months after treatment.
• 93% of patients said Restylane Eyelight improved their undereye hollows 18 months after optimal treatment.
• 92% of patients were pleased with their results at 3 months after treatment.
• Restylane Eyelight exhibited comparable efficacy and safety when injected with needles and cannula devices.

 In a consumer research study evaluating before and after photos of people treated with Restylane Eyelight, 2 out of 3 consumers said they would consider treatment after seeing the results.

 "Restylane Eyelight is an exciting new treatment option for patients. 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,” says Bill Andriopoulos, PhD, the Vice President of Medical Affairs at Galderma U.S.

Carolyn Jacob, MD, a dermatologist based in Chicago and a lead investigator in the clinical trial of Restylane Eyelight, sees firsthand how undereye concerns are top of mind for consumers.

"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," she says.

 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 had reduced undereye hollowness at 3 months, 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. The study also yielded high satisfaction, with 93% of patients expressing interest in receiving treatment again after 12 months.

Restylane's legacy with safety continues with this Phase 3 trial where most patients (87%) did not experience adverse events related to treatment with Restylane Eyelight,6 giving patients a new treatment option that is safe and effective for the under eyes.

 The most commonly observed side effects for undereye injection are swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site.1,6 Most adverse events were mild in severity (75%) and none were severe. There was no incidence of Tyndall effect (blue discoloration) after treatment with Restylane Eyelight.