The U.S. Food and Drug Administration (FDA) has approved Galderma’s Restylane Eyelight for the treatment of undereye hollows in adults aged 21 years and over.
Restylane Eyelight is an undereye hyaluronic acid (HA) dermal filler and is the first and only product in the U.S. formulated with non-animal stabilized hyaluronic acid (NASHA) technology for volume loss under the eyes.
FDA approval comes after data from a randomized, multicenter, phase 3 clinical study revealed that 87% of patients had reduced undereye hollowness at three months. A total of 92% of the patients in the study stated they were pleased with their results at three months, with 84% still being pleased through to one year. The study also revealed that 93% of patients expressed interest in receiving the treatment again after 12 months.
Restylane Eyelight is considered safe and effective. Researchers reported that the majority of the patients in the study (87%) did not experience any adverse events. The majority of those that did experience adverse events reported them as mild and these included swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site. None of the adverse events were severe.
Restylane Eyelight will be available in aesthetic practices across the country in the coming months.