Genentech’s Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to 4 Months for People with RVO in Phase 3 Trials

Genentech announced positive topline long-term results from the global phase 3 BALATON and COMINO studies evaluating extended treatment intervals with Vabysmo (faricimab-svoa) 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 people treated with Vabysmo extended their treatment intervals up to every 4 months while maintaining the vision gains achieved in the first 24 weeks of the trials. 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 personalized treat-and-extend dosing regimen in both global phase 3 BRVO and CRVO trials, according to Genentech. In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials.

“These are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, said in a company news release. “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.”

RVO impacts 28 million people globally and more than 1 million people in the United States. If approved by the FDA, RVO would be the third indication for Vabysmo in addition to wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

Detailed results from weeks 24 to 72 of the phase 3 BALATON and COMINO studies will be presented at an upcoming medical meeting.

Data from the first 24 weeks of the phase 3 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 FDA and European Medicines Agency (EMA). A decision from the FDA is expected in late 2023.

Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. 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 wet AMD and DME, including the United States, Japan, the United Kingdom and the European Union, with more than 1.5 million doses distributed globally.