The FDA has rejected Regeneron Pharmaceuticals’ application for a prefilled syringe version of Eylea HD (aflibercept 8 mg), issuing a complete response letter (CRL) last week due to unresolved manufacturing issues at a third-party facility.

The letter cites ongoing inspection concerns at Catalent Indiana, LLC—now owned by Novo Nordisk—which manufactures the prefilled syringe. The facility in Bloomington, Indiana, had previously received an “official action indicated” (OAI) status after a July 2025 inspection. The FDA noted that the deficiencies were not specific to Eylea HD, but still prevented approval.

Regeneron stated it plans to resubmit the application with a new manufacturing partner by January 2026. Meanwhile, the FDA is still reviewing a separate sBLA for 4-week dosing of Eylea HD and for treatment of macular edema following retinal vein occlusion, with a decision expected in late November 2025. A ruling on a different vial filler for Eylea HD is anticipated by late December 2025. RP