On 16 January 2026, Bayer announced that the European Commission has approved Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion. This is the third indication approved in Europe for Eylea™ 8mg.
The EU approval follows a positive opinion of the EMA’s CHMP for the new indication in December 2025. Eylea™ 8mg was first approved in the EU in January 2024 for the treatment of nAMD and diabetic macular oedema.
Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
Eylea HD® was FDA approved for the RVO indication in November 2025, following US vial approval for nAMD, DME and diabetic retinopathy in August 2023. Eylea™ 8mg is also approved for nAMD and DME (as intravitreal injection) in multiple other countries, including 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 including in Japan (May 2025).
Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea™ 8mg. In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe. Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.