On 23 March 2026, Bayer announced that Japan’s Ministry of Health, Labour and Welfare has approved Eylea™ 8 mg (aflibercept 8mg) for the treatment of macular oedema following retinal vein occlusion (RVO). RVO is the third indication for Eylea™ 8mg in Japan, in addition to nAMD and DME (approved January 2024).
Eylea™ 8mg (‘high dose’), 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® is approved for RVO in the US (November 2025), Europe (January 2026), the UK (February 2026) and Korea (February 2026). It is also approved for nAMD and DME (as intravitreal injection) in those and multiple other countries, including 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. Alvotech has recently indicated that it expects to file the first regulatory submission for AVT29 sometime in 2026.
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).