On April 18, 2025, Regeneron received a complete response letter (CRL) from the FDA regarding its supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept 8 mg) seeking approval for extended dosing intervals up to every 24 weeks across all approved indications134.
The CRL did not identify any issues with the safety or efficacy of Eylea HD for its currently approved uses and dosing regimens134.
FDA's decision means Regeneron's application to allow dosing intervals greater than the currently indicated maximum of every 16 weeks was not accepted3.
Regeneron is evaluating the FDA’s response and determining its next steps, but has stated the previously assigned FDA action (PDUFA) date for a related application is August 19, 2025, likely causing a delay for any new approval13.
This CRL follows a prior acceptance of Regeneron's sBLA for Eylea HD for expanded indications, including treatment of macular edema following retinal vein occlusion (RVO) and monthly dosing, which also targets the August 2025 decision date1.
Eylea HD is currently approved in the US for dosing intervals between 8–16 weeks for neovascular age-related macular degeneration and diabetic macular edema; and 8–12 weeks for diabetic retinopathy, after three initial monthly doses13.
Regeneron’s Eylea franchise saw a 26% drop in sales during Q1 2025 (compared to Q1 2024), despite a 54% growth in Eylea HD sales within that period2.
Sources:
1. https://www.pearceip.law/2025/04/18/fda-issues-crl-for-extended-dosing-intervals-of-regenerons-eylea-hd/
2. https://www.fiercepharma.com/pharma/regenerons-eylea-hd-suffers-double-whammy-poor-sales-and-second-surprise-fda-rejection
3. https://www.ophthalmologytimes.com/view/regeneron-announces-fda-issues-crl-for-aflibercept-8-mg-eylea-hd-sbla
4. https://www.globenewswire.com/news-release/2025/04/18/3064246/0/en/Regeneron-Provides-Update-on-EYLEA-HD-aflibercept-Injection-8-mg-Supplemental-Biologics-License-Application.html