On 27 June 2025, Bayer announced that the European Commission has granted a label extension for Eylea™ 8mg (aflibercept, 114.3mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of nAMD and visual impairment due to diabetic macular oedema (DME).
This news comes just over a month after the label extension was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 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.
Eylea™ 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of nAMD and DME. Regeneron/Bayer have recently submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following retinal vein occlusion (RVO) in Japan (May 2025), Europe (April 2025) and the US (application accepted by FDA for priority review in April 2025, with a target action date of 19 August 2025).