On 18 October 2024, Regeneron announced positive three year results for Eylea HD® (aflibercept, 8 mg injection) from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular oedema (DME). The results were presented at the American Academy of Ophthalmology (AAO) Annual Meeting.
The data reportedly demonstrates 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. Patients who switched to Eylea HD® reportedly experienced slower fluid re-accumulation following their first dose. According to Regeneron, the longer dosing intervals and slower fluid re-accumulation supports the longer duration of action of Eylea HD®.
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).
More recently, high dose Eylea® pre-filled syringe (OcuClick) was approved in Australia (October 2024) and Europe (September 2024).