On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).
Eylea® 8mg was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both low (2mg) and high dose Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.
High dose Eylea® pre-filled syringe (OcuClick™) has also been approved in Australia (October 2024) and Europe (September 2024).
High dose Eylea® for intravitreal injection is approved for nAMD and DME in the EU (January 2024), Japan (January 2024), the UK (January 2024) and Australia (June 2024). On 10 February 2025, Bayer announced that it submitted a marketing authorisation application to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for nAMD and DME.