Bayer has submitted an application to the European Medicines Agency (EMA) seeking approval for Eylea 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) for the treatment of macular oedema following retinal vein occlusion (RVO), the company announced on 8 April.
This latest application aims to expand the treatment indications for Eylea 8mg, which was initially approved in Europe for neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME) in January 2024, with extended treatment intervals of up to five months.
Bayer has submitted an application to the European Medicines Agency (EMA) seeking approval for Eylea 8mg… for the treatment of macular oedema following retinal vein occlusion (RVO)
The company is also pursuing longer treatment intervals for existing indications. On 10 February 2025, Bayer announced its submission of a marketing authorisation application to the EMA for expanded treatment intervals of up to six months with Eylea 8mg for both nAMD and DME.
Global Approvals
Eylea 8mg was approved for the treatment of nAMD and DME in Australia in June 2024.Additionally, it has received approvals across several major markets:
- United States (August 2023): approved for nAMD, DME, and diabetic retinopathy
- Japan and United Kingdom (January 2024): approved for nAMD and DME
- Korea (April 2024): approved for nAMD and DME
The OcuClick pre-filled syringe presentation of aflibercept 8mg for nAMD and DME also has approval in Australia, Europe and Canada.
Development and Marketing Rights
Eylea 8mg was jointly developed by Bayer and Regeneron. Under their agreement, Regeneron maintains exclusive rights to both 2mg and 8mg Eylea in the United States, while Bayer holds those rights in territories outside the US. The companies equally share profits from sales of the products in Bayer’s territories.
Biosimilar Landscape
The application comes amid a growing landscape of aflibercept 2mg biosimilars in Europe, with seven currently approved: Biocon’s Yesafili (September 2023), Sandoz’s Afqlir (November 2024), Samsung Bioepis/Biogen’s Opuviz (SB15) (November 2024), Formycon/Klinge’s Baiama and Ahzantive (January 2025), Celltrion’s Eydenzelt (February 2025), and Amgen’s Pavblu (April 2025)
Additionally, Amgen’s Skojoy received a positive recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted Marketing Authorisation Applications to the EMA for aflibercept 2mg biosimilars.
