On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval increases the maximum dosing interval from 16 weeks to 20 weeks provided the patient has seen one year of successful treatment response based on visual and anatomic outcomes. According to Regeneron, “[a]pproval is based on 96-week data from 2 pivotal trials [PUSLAR and PHOTON] showing majority of EYLEA HD patients maintained their visual and anatomic improvements with extended dosing intervals.” Data from the PULSAR and PHOTON trials has been added to the EYLEA HD label.
Approval for the new EYLEA HD dosing regimen comes nearly one year after the FDA’s complete response letter to Regeneron’s request for an extension in dosing schedule up to every 24 weeks. According to Regeneron, the “[n]ew EYLEA HD dosing regimen allows patients with wAMD and DME to be treated as infrequently as 2 to 3 times a year, further extending the widest range of dosing intervals of any approved injectable anti-VEGF [treatment].”