Regeneron Delays Regulatory Submission for Eylea HD Pre-Filled Syringe After CRL

In its third quarters earnings filing, Regeneron said it received another complete response letter (CRL) from the FDA for its pre-filled syringe supplemental BLA (sBLA) for Eylea HD (aflibercept injection 8 mg). The sole approvability issue cited in the CRL relates to unresolved inspection findings at its manufacturer Catalent.

In April, the FDA issued the first complete response letter (CRL) regarding the sBLA for the addition of extended dosing intervals (up to every 24 weeks) for Eylea HD across all approved indications. According to Regeneron, the CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens.

This month, Regeneron was notified by Catalent that they received an official action indicated (OAI) letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection (not specific to Eylea HD).

Regeneron said it is now planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the Eylea HD BLA.

There is also an sBLA under review by the FDA for Eylea HD every-4-week dosing and for the treatment of macular edema following retinal vein occlusion (RVO), which has a target action date in late November 2025. In addition, the company has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.

Eylea HD remains available in the US through vial administration. It is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses.