European Commission Approves Roche’s Vabysmo for RVO

The European Commission has approved Roche’s Vabysmo® (faricimab) for the treatment of macular edema secondary to retinal vein occlusion (RVO), including both branch and central retinal vein occlusion (BRVO and CRVO). This approval is a significant milestone, making Vabysmo the first bispecific antibody available in the European Union for this indication, adding to its existing approvals for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Key Study Findings

The approval is based on data from two global Phase III studies, BALATON and COMINO, which involved over 1,200 patients. These studies demonstrated that Vabysmo provided early and sustained improvements in vision, showing non-inferior results to aflibercept. Additionally, Vabysmo was effective in achieving rapid and robust retinal drying, an essential factor in reducing vision impairment associated with macular edema.

Extended Treatment Intervals

The studies also revealed that nearly 60% of patients receiving Vabysmo were able to extend their treatment intervals to three or four months, offering a significant advantage over current treatments, which typically require more frequent injections.

Expanding Global Reach

Vabysmo is already approved in several countries, including the US and Japan, for RVO, and in nearly 100 countries for nAMD and DME. This recent approval by the European Commission further solidifies Roche’s commitment to advancing treatments for vision-threatening retinal conditions.

For more detailed information, read the full press release on Roche’s website.

Understanding Retinal Vein Occlusion

Retinal vein occlusion (RVO) is one of the most common retinal vascular disorders and can lead to sudden, severe vision loss. It occurs when a blockage forms in the veins carrying blood away from the retina, leading to fluid buildup and swelling in the retina, known as macular edema. RVO affects an estimated 28 million adults globally, predominantly those over the age of 60, and presents a significant risk for long-term vision impairment if not adequately treated. Vabysmo’s approval provides a much-needed treatment option for this debilitating condition.