BALATON, COMINO phase III studies of Vabysmo for people with retinal vein occlusion meet primary endpoints: Roche
Basel: Roche has announced positive topline results from two global phase III studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, Vabysmo (faricimab), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). RVO is a vision-threatening condition that impacts 28 million people globally.
Both studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every four weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every four weeks.
"These encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "The results add to the extensive evidence supporting Vabysmo's efficacy in treating multiple types of retinal conditions. We look forward to submitting these data to regulatory authorities."
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