On 9 September 2024, Bayer announced that the European Medicines Agency (EMA) has approved its Eylea™ (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick™”, for nAMD and diabetic macular oedema (DME). Bayer reports that Germany will be one of the first launch markets for high dose Eylea™ PFS.
Eylea™ 8mg was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both low and high dose Eylea™ in the US, while Bayer has those outside the US where the companies equally share the profits from sales of the products.
High dose Eylea™ for intravitreal injection has previously been approved in the US (August 2023), as Eylea® HD, for nAMD, DME and diabetic retinopathy. It has also been approved in multiple countries for nAMD and DME including the EU (January 2024), Japan (January 2024), the UK (January 2024), Korea (April 2024) and Australia (June 2024).