Restylane Eyelight for Undereye Hollows is Approved by the FDA

Galderma declared in a press release that Restylane Eyelight, an undereye hyaluronic acid dermal filler, has been approved by the FDA for the treatment of undereye hollows in adults over the age of 21.

Restylane Eyelight is the first and only product in the United States to use NASHA (non-animal stabilized hyaluronic acid) technology to treat volume loss under the eyes, according to the press release.

“Restylane Eyelight is an exciting new treatment option for patients,” Bill Andriopoulos, PhD, vice president of medical affairs at Galderma U.S., said in the release. “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.”

Information from a randomized, multicenter, phase 3 clinical study were used to help the approval. Results from the review showed that 87% of patients had diminished undereye hollowness at 90 days, with 92% of patients happy with the results. Following 1 year, 84% of these patients were as yet satisfied with their improvement.

Swelling, redness, tenderness, pain, bruising, itching, and lumps or bumps at the injection site were the most common mild side effects that 87% of patients reported. None were severe, and the Tyndall blue discoloration effect did not occur after treatment.

Restylane Eyelight will be available in aesthetic practices across the country in the coming months, according to the release.