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Bayer’s High Dose Eylea® (Aflibercept) PFS Approved in Australia

Oct 8, 2024

On 8 October 2024, Australia’s Therapeutic Goods Administration (TGA) approved Bayer’s Eylea® (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick”, for nAMD and diabetic macular oedema (DME).

This follows approval of high dose Eylea® PFS (OcuClick) in Europe last month.

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 holds 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 for nAMD and DME in Australia (June 2024), the EU (January 2024), Japan (January 2024), and the UK (January 2024).  Eylea® HD was approved for nAMD, DME and diabetic retinopathy in the US (August 2023).