EU Commission approves Roche's Vabysmo for retinal vein occlusion treatment

Roche has announced that the European Commission (EC) has approved Vabysmo® (faricimab) for treating visual impairment caused by macular edema secondary to retinal vein occlusion (RVO). This condition includes both branch and central retinal vein occlusion (BRVO and CRVO). This approval marks the third indication for Vabysmo in the European Union, adding to its previous approvals for neovascular or 'wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME). These three retinal conditions collectively affect nearly 80 million people globally and are significant causes of vision loss.

According to Dr. Levi Garraway, Roche's Chief Medical Officer, Vabysmo offers a new treatment option that not only improves and preserves vision but also aids in retinal drying. The drug's efficacy and safety have been established through extensive clinical trials and real-world evidence, with many patients already benefiting from the treatment worldwide.

The EC's approval is grounded in positive results from the Phase III BALATON and COMINO studies. These studies involved over 1,200 participants with macular edema due to BRVO and CRVO. The results demonstrated that Vabysmo provided early and sustained improvements in vision comparable to aflibercept, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks. Additionally, Vabysmo achieved rapid and effective drying of retinal fluid, an essential clinical measure since retinal swelling can severely affect vision.

Long-term data up to 72 weeks indicated that almost 60% of patients in the BALATON study and nearly 48% in the COMINO study could extend their treatment intervals to three or four months. Typically, existing treatments for RVO require injections every one to two months. Both studies confirmed that Vabysmo was well tolerated with a safety profile consistent with previous research.

Vabysmo is unique as it is the first bispecific antibody approved for ocular use. It targets and inhibits two pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A)—that are associated with various vision-threatening retinal conditions. By neutralizing these pathways, Vabysmo aims to restore vascular stability.

Initially approved by the U.S. Food and Drug Administration in October 2023 and by Japan's Ministry of Health in March 2024, Vabysmo has since been made available in nearly 100 countries for treating nAMD and DME. To date, more than four million doses have been distributed globally.

RVO is the second most common retinal vascular disease causing vision loss, affecting an estimated 28 million adults worldwide, predominantly those over 60. The condition often leads to sudden and painless vision loss due to vein blockage, which disrupts normal blood flow and leads to retinal swelling. Current treatments involve repeated intravitreal injections of anti-VEGF therapies.

There are two main types of RVO: branch retinal vein occlusion, affecting more than 23 million people globally, and central retinal vein occlusion, affecting over four million people. The BALATON study included 553 participants with BRVO, while the COMINO study involved 729 participants with central retinal or hemiretinal vein occlusion.

The primary outcome measure for both studies was the change in best-corrected visual acuity from baseline at 24 weeks, with secondary measures including changes in central subfield thickness and retinal fluid drying. Vabysmo's approval is supported by a robust Phase III clinical development program, which includes several ongoing trials aimed at evaluating the long-term safety and efficacy of the drug in various retinal conditions.

Through innovative scientific research and a focus on personalized healthcare, Roche aims to offer pioneering treatments for preventing vision loss from major retinal diseases. With a comprehensive pipeline of therapies targeting multiple vision-threatening conditions, Roche continues to develop groundbreaking treatments that address unmet medical needs in the field of ophthalmology.