FDA Approves Extended EYLEA HD Dosing Interval for Wet AMD and DME
Summary
The FDA approved an extension of the maximum dosing interval for Regeneron's EYLEA HD (aflibercept) from 16 weeks to 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval is based on 96-week data from the PULSAR and PHOTON pivotal trials, which demonstrated that the majority of patients maintained visual and anatomic improvements with extended dosing intervals. The new regimen allows patients to be treated as infrequently as 2 to 3 times per year.
What changed
The FDA approved an extension of the maximum dosing interval for EYLEA HD (aflibercept) from 16 weeks to 20 weeks for patients with wet age-related macular degeneration and diabetic macular edema, provided patients have demonstrated one year of successful treatment response based on visual and anatomic outcomes. This approval, based on 96-week data from the PULSAR and PHOTON pivotal trials, allows for treatment as infrequently as 2 to 3 times per year, extending the widest range of dosing intervals of any approved injectable anti-VEGF treatment.
Healthcare providers administering EYLEA HD should be aware that the drug label has been updated to reflect the new extended dosing regimen. Patients who have completed one year of successful treatment may be eligible for the less frequent dosing schedule. This follows nearly one year after the FDA issued a complete response letter regarding Regeneron's initial request for dosing intervals up to every 24 weeks.
What to do next
- Monitor for updates on EYLEA HD prescribing information
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Apr 15, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
April 15, 2026
FDA Approves Extended Dosing Interval for Regeneron’s EYLEA HD (aflibercept)
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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].”
[View source.]
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