On 20 August 2025, Regeneron announced that the FDA has extended its target action dates to Q4/2025 for two Eylea HD® (aflibercept, 8mg) regulatory submissions:
- a supplemental BLA (accepted by the FDA for Priority Review in April 2025) seeking approval for the treatment of macular oedema following retinal vein occlusion (RVO) and an extension of the dosing schedule to include every 4-week dosing across approved indications; and
- a prior approval supplement for the Eylea HD® pre-filled syringe.
The extension to the review period is a result of FDA observations based on a site inspection at the filling site owned by Novo Nordisk (previously Catalent). Novo Nordisk submitted a response in early August 2025 to address the FDA’s observations.
Eylea HD® (known as Eylea™ 8mg in Europe) 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 HD® is approved for nAMD, DME and diabetic retinopathy in the US (August 2023). Eylea™ 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024). Eylea™ 8mg pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024). In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).
Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea™ 8mg.