Bayer’s Eylea™ 8mg has received approval in both the UK (reported 25 February 2026) and Korea (reported 27 February 2026) for an expanded indication to include macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion. RVO is the third indication for Eylea™ 8mg in both the UK and Korea, in addition to nAMD and DME.
Eylea™ 8mg has also received Korean approval to extend the dosing interval from a minimum of 4 weeks to a maximum of 24 weeks and to shorten the minimum maintenance treatment interval from 8 weeks to 4 weeks.
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.
High dose Eylea® was FDA approved for the RVO indication in November 2025 and received European Commission approval for the same indication extension in January 2026. Eylea™ 8mg is also approved for nAMD and DME (as intravitreal injection) in multiple other countries, including Japan (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 RVO indication in countries including 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.
Biosimilars of Regeneron/Bayer’s Eylea® 2mg (aflibercept, 2mg) are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu®/Opuviz® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).