On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg). The only issue cited in the CRL relates to unresolved inspection findings at Catalent, the manufacturer filler included in the sBLA. On 9 October 2025, Catalent received an “official action indicated” classification from the FDA, indicating that it is in an “unacceptable state of compliance” after an FDA inspection. Regeneron intends to submit an application to the FDA to include an additional PFS manufacturing filler in the Eylea HD® BLA by January 2026.
Regeneron’s Eylea HD® (aflibercept, 8mg) is already approved in the US in a vial form for nAMD, DME and diabetic retinopathy (August 2023). Regeneron has also filed an sBLA in the US for the use of Eylea HD® to treat macular oedema following retinal vein occlusion (RVO) and for an extension of the dosing schedule to include every 4-week dosing across approved indications. Regeneron 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® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024). Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025). In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).
Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.