On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA HD (aflibercept). The supplemental application is for the addition of extended dosing intervals (up to every 24 weeks) of EYLEA HD injection 8 mg across all approved indications. The FDA disagreed with Regeneron’s proposal to add additional extended dosage intervals of greater than every 16 weeks, which is the maximum dosing interval on the currently approved label. Regeneron has not yet responded to the letter.
Currently, EYLEA HD is approved for dosing intervals of 8-16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). For patients with diabetic retinopathy (DR), EYLEA HD is approved for 3 initial monthly dosages, with subsequent dosage intervals of 8-12 weeks.
[View source.]
