By Fineline Cube 
German pharmaceutical giant Bayer (ETR: BAYN) announced that it has submitted an indication approval filing to the European Medicines Agency (EMA) for Eylea 8 mg (aflibercept 8 mg). The proposed indication is macular edema following retinal vein occlusion (RVO), including central, branch, and hemiretinal vein occlusion. This filing is supported by positive results from the Phase III QUASAR study, which demonstrated non-inferior visual acuity gains compared to the current standard therapy, Eylea 2 mg.
Clinical Trial Results
In the QUASAR study, patients receiving aflibercept 8 mg every 8 weeks (after initial monthly doses) showed comparable visual acuity improvements to those receiving Eylea 2 mg every 4 weeks. Approximately 90% of patients on the 8 mg regimen maintained 8-week dosing intervals through 36 weeks, with nearly 70% extending to 12-week intervals. These results highlight the potential for extended dosing intervals, reducing treatment burden while maintaining efficacy.
Regulatory and Market Context
Eylea, co-developed with Regeneron (NASDAQ: REGN), has been approved for various ophthalmic indications since its FDA approval in November 2011. In the EU and UK, Eylea 8 mg is the only anti-VEGF therapy approved for extended treatment intervals of up to 5 months for nAMD and DME. In February 2025, Bayer filed to extend treatment intervals to 6 months for these conditions, leveraging data from the PULSAR and PHOTON studies.-Fineline Info & Tech