Regeneron Pharmaceuticals, Inc. Receives FDA Approval To Extend Dosing Intervals For EYLEA HD In Wet AMD And Diabetic Macular Edema

Regeneron Pharmaceuticals, Inc. Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration U.S. Food and Drug Administration has approved an extension of dosing intervals for its retinal therapy EYLEA HD (aflibercept). The update allows eligible patients with wet age-related macular degeneration and diabetic macular edema to receive injections as infrequently as every 20 weeks after completing one year of successful treatment. The FDA simultaneously updated the product’s labeling to incorporate new 96-week data from the pivotal PULSAR and PHOTON trials, which showed that visual and anatomic improvements were maintained through two years, even with extended treatment intervals.

According to the findings added to the label, many patients were able to lengthen their dosing schedules over time. By week 96, 71% of wet AMD patients in the PULSAR trial had reached intervals of at least 16 weeks, and 47% had reached 20-week intervals. In the PHOTON trial for diabetic macular edema, 72% achieved 16-week intervals, while 44% reached 20 weeks. Across both trials, most patients who completed the two-year period either maintained or further extended their dosing schedules while preserving earlier treatment gains.

Michael A. Klufas, M.D., of the Wills Eye Hospital Wills Eye Hospital Retina Service, said the expanded dosing flexibility marks a major step forward for patient care. He noted that the possibility of requiring only two or three injections a year for certain individuals could significantly ease the long-term treatment burden. Klufas added that the newly included 96-week data reinforce confidence that patients can sustain their improvements with a safety profile comparable to the 2 mg version of EYLEA.

Regeneron highlighted that EYLEA HD now offers the broadest range of dosing intervals among approved injectable anti-VEGF therapies, giving clinicians more room to tailor treatment plans. Patients who require more frequent therapy may continue with four-week dosing, while others who respond well over time may extend up to 20-week intervals based on medical criteria in the U.S. Prescribing Information.

George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron George D. Yancopoulos, said the approval further strengthens the company’s commitment to reducing patient burden without compromising outcomes. He noted that EYLEA HD offers a level of durability unmatched by existing anti-VEGF treatments and gives retina specialists an expanded set of options for individualized care.

The company reported that the most common side effects observed in at least 3% of patients included cataract, conjunctival hemorrhage, corneal epithelial defects, increased intraocular pressure, eye discomfort or irritation, retinal hemorrhage, blurred vision, vitreous detachment and floaters. Beyond this approval, the FDA is also reviewing a prefilled syringe version of EYLEA HD, with a target decision date set for April 2026 under a Chemistry, Manufacturing and Controls prior-approval supplement.

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