Roche Reports P-III Studies (BALATON) & (COMINO) Results of Vabysmo (faricimab) for the Treatment of Retinal Vein Occlusion
- The P-III studies evaluating Vabysmo vs aflibercept in 553 & 729 patients with branch & central retinal or hemiretinal vein occlusion
- The results showed that patients treated with Vabysmo extended their treatment intervals up to q4mos. The first 24wk. results from both studies showed early & sustained vision improvement, was well-tolerated and the safety profile was consistent with prior studies
- Both studies met their 1EPs of non-inferior vision gains vs aflibercept while 2EPs showed rapid & robust drying of retinal fluid from baseline to 24wk. as measured by reduction in central subfield thickness. The results have been submitted to global health authorities, incl. the US FDA & EMA with an expected decision from the US FDA in late 2023
Ref: Globe Newswire | Image: Roche
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