On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients with macular oedema following retinal vein occlusion (RVO).
This comes a month after Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the same indication in April 2025.
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.
Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following RVO, and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review in April 2025. The FDA’s target action date is 19 August 2025.