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).