The U.S. Food and Drug Administration approved extended dosing intervals for Regeneron Pharmaceuticals Inc.'s (NASDAQ: REGN) EYLEA HD up to every 20 weeks for patients with wet age-related macular degeneration and diabetic macular edema following one year of successful treatment response.

The approval allows some patients to receive EYLEA HD injections as infrequently as two to three times per year after demonstrating successful response based on visual and anatomic outcomes. The FDA updated the EYLEA HD label to include 96-week data from the PULSAR trial in wet AMD and the PHOTON trial in diabetic macular edema.

In the PULSAR trial, 71% of patients with wet AMD achieved dosing intervals of 16 weeks or longer, while 47% reached intervals of 20 weeks or longer at week 96. For diabetic macular edema patients in the PHOTON trial, 72% attained intervals of 16 weeks or longer and 44% reached 20-week intervals.

EYLEA HD can now be individualized for patients requiring treatment as frequently as every four weeks or as infrequently as every 20 weeks, based on criteria in the prescribing information. The treatment maintains the same safety profile as the standard EYLEA 2 mg formulation.

The most common adverse reactions reported in patients treated with EYLEA HD included cataract, conjunctival hemorrhage, corneal epithelium defect, increased intraocular pressure, and eye discomfort. The FDA has a target action date in April 2026 for reviewing the EYLEA HD prefilled syringe.

Wet age-related macular degeneration affects an estimated 1.4 million Americans, while approximately 1.5 million adults are diagnosed with diabetic macular edema in the United States.