On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept 8mg, 114.3 mg/ml solution for injection) with expanded treatment intervals of up to 6 months for nAMD and diabetic macular oedema. Bayer expects marketing authorisation from the European Commission within the next few weeks.
This news comes two days after Bayer’s 21 May 2025 announcement that the Center for Drug Evaluation of China’s National Medical Products Administration has approved Eylea™ 8mg (aflibercept 8mg) for nAMD in China.
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/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).