The European Commission (EC) has approved Vabysmo® (faricimab) for treating visual impairment caused by macular edema secondary to retinal vein occlusion (RVO), which includes branch RVO and central RVO. This marks the third approved indication for Vabysmo in the European Union, alongside neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Together, these retinal conditions affect nearly 80 million people worldwide, contributing significantly to vision loss.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, stated, “Vabysmo offers a new treatment option in Europe for people with retinal vein occlusion, helping to preserve and improve vision with the additional benefit of retinal drying. The efficacy and safety of Vabysmo have been confirmed through global clinical trials and are further supported by extensive real-world evidence, with hundreds of thousands of people treated globally.”
The EC’s approval is based on positive results from two global Phase III studies, BALATON and COMINO, which involved over 1,200 patients with macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). Prof. Frank Holz, chairman and professor at the Department of Ophthalmology, University of Bonn, Germany, emphasized the importance of this approval, noting that it could significantly impact individuals with retinal vein occlusion and their caregivers, who struggle with the disease’s effects on daily activities.
The studies showed that monthly Vabysmo treatment provided early and sustained improvements in vision for people with BRVO and CRVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Additionally, Vabysmo demonstrated rapid and robust drying of retinal fluid, a crucial clinical measure since swelling from excess fluid can lead to distorted and blurred vision.
Long-term data up to 72 weeks revealed that nearly 60% of BALATON participants and 48% of COMINO participants could extend their treatment intervals to three or four months, compared to the more frequent treatments required by current options.
Vabysmo is the first and only bispecific antibody approved for the eye, designed to target and inhibit two key signaling pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A)—that contribute to several vision-threatening retinal conditions. Vabysmo neutralizes these pathways to restore vascular stability.
Vabysmo was first approved for RVO by the U.S. Food and Drug Administration in October 2023, followed by approval from Japan’s Ministry of Health, Labour, and Welfare in March 2024. The treatment is now available in nearly 100 countries for nAMD and DME, with over four million doses distributed worldwide.
About Retinal Vein Occlusion (RVO)
RVO is the second leading cause of vision loss from retinal vascular diseases, affecting an estimated 28 million adults globally, primarily those aged 60 or older. It can cause severe and sudden vision loss due to restricted blood flow in the affected retina, leading to ischemia, bleeding, fluid leakage, and retinal swelling (macular edema). Elevated levels of Ang-2 are thought to drive disease progression, along with VEGF.
There are two main types of RVO: branch retinal vein occlusion, affecting over 23 million people worldwide, occurs when one of the smaller branches of the main central retinal vein is blocked; central retinal vein occlusion, affecting over four million people globally, occurs when the central retinal vein is blocked.
About the BALATON and COMINO Studies
The BALATON (NCT04740905) and COMINO (NCT04740931) studies were randomized, multicenter, global Phase III trials comparing the efficacy and safety of Vabysmo®️ (faricimab) to aflibercept. The trials involved over 1,200 patients with macular edema due to BRVO and CRVO, who received either Vabysmo or aflibercept injections.
About Vabysmo® (Faricimab)
Vabysmo is the first bispecific antibody approved for eye treatment. It targets Ang-2 and VEGF-A pathways, both linked to vision-threatening retinal conditions. By blocking these pathways, Vabysmo helps stabilize blood vessels and prevent vision loss.
Vabysmo has been approved in nearly 100 countries, including the United States, Japan, the United Kingdom, and the European Union, for nAMD and DME treatment, and in several countries, including the U.S. and Japan, for RVO. Ongoing reviews by other regulatory authorities are underway.
