FDA approves Restylane Eyelight for undereye hollows

Key takeaways:

• Restylane Eyelight is the first U.S. product formulated with non-animal stabilized hyaluronic acid technology for volume loss under the eyes.
• 84% of patients expressed satisfaction in results after 1 year.

The FDA has approved Restylane Eyelight, an undereye hyaluronic acid dermal filler, for the treatment of undereye hollows in adults aged 21 years and older, Galderma announced in a press release.

According to the release, Restylane Eyelight is the first and only U.S. product formulated with non-animal stabilized hyaluronic acid (NASHA) technology for volume loss under the eyes.

“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.”

Data from a randomized, multicenter, phase 3 clinical study were used to support the approval. Results from the study showed that 87% of patients had reduced undereye hollowness at 3 months, with 92% of patients satisfied with results. After 1 year, 84% of these patients were still pleased with their improvement.

While 87% of patients did not experience adverse events, the majority of those that did reported mild events that included swelling, redness, tenderness, pain, bruising, itching and lumps or bumps at the injection site. None were severe and there was no incidence of Tyndall blue discoloration effect post-treatment.

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