On 28 August 2025, Bayer announced that it has received approval from Korea’s Ministry of Food and Drug Safety for its OcuClick pre-filled syringe (PFS) presentation of Eylea® 8mg (aflibercept). The PFS presentation is indicated for nAMD and diabetic macular oedema (DME), the same indications as the vial presentation.
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® 8mg was approved in Korea in April 2024. The high dose form of Eylea® is also approved for nAMD, DME and diabetic retinopathy in the US (August 2023) and for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024). An OcuClick PFS presentation of aflibercept 8mg for nMAD and DME is approved in Canada (February 2025), Australia (October 2024) and Europe (September 2024).
Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg.