Vabysmo maintained vision improvements with extended treatment intervals up to 4 months for people with retinal vein occlusion in phase III studies: Roche
Basel: Roche has announced positive topline long-term results from the global phase III BALATON and COMINO studies, evaluating extended treatment intervals with Vabysmo (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).
From weeks 24 to 72, all people in both studies received Vabysmo using a treat-and-extend dosing regimen, which allows tailoring of their treatment interval according to the individual patient's response to treatment. Data showed that people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the studies. Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness. This is the first time that vision and anatomical improvements have been maintained for more than a year using a personalised treat-and-extend dosing regimen in global phase III studies for both BRVO and CRVO. In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous studies.
“These are the first retinal vein occlusion (RVO) studies to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch RVO,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition.”
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