FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD

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FDA Rejects Regeneron’s Proposal for Extended Dosing Interval of Eylea HD (Aflibercept 8 mg)

The FDA has issued a Complete Response Letter (CRL) to Regeneron, rejecting its supplemental Biologics License Application that sought to allow extended dosing intervals (up to every 24 weeks) for Eylea HD (aflibercept 8 mg) across all approved indications1 3 4 5.
The rejection specifically concerns dosing intervals longer than the currently approved maximum of every 16 weeks. The FDA did not identify any safety or efficacy concerns with aflibercept 8 mg itself, but did not support Regeneron’s proposal to extend intervals1 3 4 5.
Under current FDA approval, Eylea HD may be dosed every 8 to 16 weeks for wAMD and DME, and every 8 to 12 weeks for DR, after the initial three monthly doses1 4.
Regeneron’s application was supported by the 1-year results of the PULSAR and PHOTON trials, which were published in March 2024. However, these results did not convince the FDA to update the dosing schedule1 4.
On the same day, the FDA approved a new indication for another Regeneron product, Dupixent, but rejected the Eylea HD dosing extension5.
This regulatory setback is viewed as a significant negative development for Regeneron, particularly given market competition and the commercial importance of Eylea HD2 5.