On 8 February 2025, at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) annual meeting, Regeneron presented positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept, 8 mg injection, known as Eylea™ 8mg in the EU and Japan) for the treatment of patients with macular oedema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions.
According to Regeneron, the QUASAR trial met its primary endpoint at 36 weeks, with patients receiving EYLEA HD® dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA® 2mg every 4 weeks.
In October 2024, Regeneron announced positive three year results for EYLEA HD® from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME), which demonstrated that the vast majority of EYLEA HD® patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year and achieved longer treatment intervals.
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). More recently, high dose EYLEA® pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).