Vabysmo maintained vision improvements with extended treatment intervals up to 4 months for people with retinal vein occlusion in phase III studies: Roche

RVO impacts 28 million people globally and, if approved, would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Together, the three conditions affect around 70 million people worldwide and are among the leading causes of vision loss.

Detailed results from weeks 24 to 72 of the phase III BALATON and COMINO studies will be presented at an upcoming medical meeting.

Data from the first 24 weeks of the phase III BALATON and COMINO studies, presented at Angiogenesis, Exudation and Degeneration 2023, demonstrated early and sustained vision improvement with Vabysmo, with both studies meeting their primary endpoints of non-inferior vision gains compared to aflibercept. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline to week 24, as measured by reduction in central subfield thickness.

Data up to 24 weeks have been submitted to global health authorities, including the United States Food and Drug Administration (U.S. FDA) and European Medicines Agency. A decision from the U.S. FDA is expected in late 2023.

Vabysmo is uniquely engineered to target and inhibit two signalling pathways, which are linked to a number of vision-threatening retinal conditions, by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability. The level of Ang-2 is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.

To date, Vabysmo is approved in more than 80 countries around the world for people living with nAMD and DME, including the United States, Japan, the United Kingdom and the European Union, with public reimbursement in over 25 markets and more than 1.5 million doses distributed globally.