Regeneron Pharma: Phase 3 Trial With EYLEA HD 8 Mg Meets Primary Endpoint - Quick Facts

(RTTNews) - Regeneron Pharmaceuticals (REGN) announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD or aflibercept injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion, including those with central, branch and hemiretinal vein occlusions. In the trial, patients treated with EYLEA HD every 8 weeks experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA Injection 2 mg, the current standard of care. Also, about 90% of EYLEA HD patients were able to maintain 8-week dosing intervals through 36 weeks.

All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing. The company said these data will be submitted to regulatory authorities around the world, with a submission to the FDA planned for the first quarter of 2025.

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