Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The findings are based on the Regeneron and Bayer sponsored Phase III PULSAR (nAMD) and Phase II/III PHOTON (DME) trials.
High Dose Eylea® is approved in multiple countries including the US (August 2023 – nAMD, DME) and diabetic retinopathy, the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME).