FDA Approves Galderma’s Restylane Eyelight

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Galderma recently announced the US Food and Drug Administration (FDA) approval of Restylane Eyelight for the treatment of undereye hollows in adult patients over the age of 21.¹ Restylane Eyelight is an undereye hyaluronic acid dermal filler and is the first and only US product formulated with NASHA Technology for volume loss. Restylane Eyelight will be available in clinics across the US in the next several months. Providers can learn more about Restylane’s availability and use at RestylaneUSA.com.

According to Bill Andriopoulos, PhD, the vice president of medical affairs at Galderma, Restylane Eyelight is similar to the body’s natural hyaluronic acid with minimal crosslinking and produces a firm gel texture that is resistant to water absorption, making Restylane Eyelight safe and a natural-looking solution.

The FDA’s approval is based on the 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. In the 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 the first year. The study also yielded high satisfaction, with 93% of patients expressing interest in receiving treatment again after 12 months.

Overall, the majority of patients (87%) did not report any adverse events related to treatment. Typically, the most common adverse events related to undereye injections are swelling, redness, tenderness, pain, bruising, itching, and bumps at the injection site. With Restylane Eyelight treatment, there was no incidence of Tyndall effect.

Galderma’s FDA-approved Restylane family of products includes Restylane, Restylane-L, Restylane Lyft with Lidocaine, Restylane Silk, Restylane Kysse, Restylane Refyne, Restylane Defyne, Restylane Contour, and now Restylane Eyelight, all of which are indicated for patients over the age of 21.

Reference

1. Galderma receives FDA approval for its newest hyaluronic acid filler, Restylane Eyelight. Galderma. Published June 5, 2023. Accessed June 5, 2023. https://www.galderma.com/GaldermaFDAapprovalforRestylaneEyelight