Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch RVO or central RVO). RVO is the third indication for Vabysmo in the European Union, in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Together, the three retinal conditions affect close to 80 million people worldwide and are among the leading causes of vision loss.
“Vabysmo is a new treatment option for people with retinal vein occlusion in Europe that can help preserve and improve vision, with the added benefit of retinal drying,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The efficacy and safety of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of real-world evidence, with hundreds of thousands of people treated worldwide.”
The approval is based on positive results from two global Phase III BALATON and COMINO studies, evaluating Vabysmo in more than 1,200 people with macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).
“People with retinal vein occlusion have limited treatment options which require regular clinic visits,” said Prof. Frank Holz, chairman and professor, Department of Ophthalmology, University of Bonn, Germany. “This approval could have a significant impact for people who have retinal vein occlusion and their caregivers, who together have to navigate the devastating impact of their disease on their ability to drive, read, socialise, travel and pursue hobbies.”
Results demonstrated that monthly treatment with Vabysmo provided early and sustained improvement in vision in people with BRVO and CRVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid. Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.
Additional longer-term data up to 72-weeks showed that nearly 60% of people receiving Vabysmo in BALATON and nearly 48% of people in COMINO were able to extend their treatment intervals to three or four months apart. Current available treatments for RVO are typically given every one to two months.
In both studies, Vabysmo was well tolerated, and the safety profile was consistent with previous studies.
Vabysmo is the first and only bispecific antibody approved for the eye, 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.
Vabysmo was first approved for RVO by the United States (US) Food and Drug Administration in October 2023, and by the Japan Ministry of Health, Labour and Welfare in March 2024. To date, Vabysmo is available in nearly 100 countries for people with nAMD and DME, with more than four million doses distributed globally.