Vabysmo maintained vision improvements with extended treatment intervals up to four months for people with retinal vein occlusion (RVO) in phase III trials

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 four 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 III BRVO and CRVO trials. 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,” said Levi Garraway, M.D., Ph.D., Genentech’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.”

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, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Together, the three conditions affect around 3 million people in the U.S. 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 FDA and European Medicines Agency. 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.

BALATON (NCT04740905) and COMINO (NCT04740931)are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo (faricimab-svoa) compared to aflibercept. For the first 20 weeks, patients are randomized 1:1 to receive six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24-72, all patients receive Vabysmo (6.0 mg) up to every four months, using a treat-and-extend approach. The BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion. The primary endpoint of each study was the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. Secondary endpoints (weeks 0-24) include change in central subfield thickness and drying of retinal fluid, from baseline over time up to week 24. Secondary endpoints (weeks 24-72) were treatment durability at 68 weeks and continuation of weeks 0-24 endpoints.