On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg (aflibercept 8 mg, 114.2 mg/ml solution for injection) for nAMD and DME.
According to Bayer, Eylea™ 8 mg was the first anti-VEGF to receive a 5-month label in the EU, but positive three-year results from the open-label extension studies of the PULSAR (nAMD) and PHOTON (DME) trials support 6-month extended treatment intervals for “a substantial proportion of patients”.
Eylea™ 8 mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron. Regeneron holds exclusive rights to Eylea® 2mg (aflibercept 2 mg) and Eylea HD® in the US, while Bayer has licensed the exclusive commercialisation rights to the products outside the US.
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). Eylea HD® is approved for nAMD, DME and diabetic retinopathy in the US (August 2023). High dose Eylea® pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).
On 8 February 2025, Regeneron presented positive results from the Phase 3 QUASAR trial investigating Eylea HD® for the treatment of patients with macular oedema following retinal vein occlusion (RVO).