On 8 April 2025, Bayer announced that it has filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for the treatment of macular oedema following retinal vein occlusion (RVO).
Eylea™ 8mg was approved in Europe for nAMD and DME in January 2024, with extended treatment intervals of up to 5 months. On 10 February 2025, Bayer announced that it had submitted a marketing authorisation application to the EMA for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for both nAMD and DME.
Eylea™ 8mg (known as Eylea® HD in the US) is also approved for nAMD and DME in Japan (January 2024), the UK (January 2024), Korea (April 2024) and Australia (June 2024). Eylea HD® was approved in the US in August 2023 for nAMD, DME and diabetic retinopathy.
An OcuClick pre-filled syringe presentation of aflibercept 8mg for nMAD and DME is approved in Canada (February 2025), Australia (October 2024) and Europe (September 2024).
Eylea™ 8mg 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.
There are currently seven aflibercept 2mg biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025). Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept 2mg biosimilars.