On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. A 4-weekly dosing option has also been approved for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).
Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® is still on hold while Regeneron seeks to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA. Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA. Regeneron plans to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.
Regeneron’s Eylea HD® was approved in the US in a vial form for nAMD, DME and DR in August 2023. Regeneron has submitted an application to include an additional vial filler in its BLA, with an FDA decision regarding this new vial filler expected by late December 2025.
Eylea® 8mg (as the product is known in other jurisdictions) is approved for nAMD and DME (as intravitreal injection) 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). 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.