Bayer (ETR: BAYN) has submitted a marketing application to the European Medicines Agency (EMA) for Eylea 8 mg (aflibercept 8 mg), seeking to extend anti-VEGF injection intervals to 6 months in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The filing builds on positive data from the PULSAR (nAMD) and PHOTON (DME) trials.
Study Results
In open-label extension studies, patients randomized to Eylea 8 mg maintained visual/anatomic improvements over three years. By year three, 28% of DME patients and 24% of nAMD patients achieved 6-month dosing intervals.
Drug Profile
Eylea, co-developed with Regeneron (Nasdaq: REGN), has been approved since 2011 for nAMD, retinal vein occlusion, diabetic retinopathy, and other eye diseases. The Eylea 8 mg formulation aims to reduce treatment frequency while preserving efficacy.
Strategic Outlook
The EMA filing positions Eylea 8 mg as a potential standard of care for extended dosing in nAMD and DME. If approved, it could improve patient compliance and reduce healthcare costs.-Fineline Info & Tech
