Vabysmo Approved in Europe for Treatment of RVO

Roche announced that the European Commission has approved Vabysmo (faricima) for the treatment of visual impairment caused by 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 wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

Vabysmo is a bispecific antibody approved for the eye that is engineered to target and inhibit two signaling pathways that are linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability.

“People with retinal vein occlusion have limited treatment options which require regular clinic visits,” Professor Frank Holz, MD, said in a Roche press release. “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, socialize, travel, and pursue hobbies.” Prof. Holz is chairman and professor, Department of Ophthalmology, University of Bonn, Germany.

The company advised that the approval is based on positive results from the global phase 3 BALATON and COMINO studies, which evaluated Vabysmo in more than 1,200 patients with macular edema caused by branch and central RVO. The BALATON study was conducted in 553 patients with branch RVO. The COMINO study was conducted in 729 patients with central RVO or hemiretinal vein occlusion.

Roche stated that the study results demonstrated that monthly treatment with Vabysmo provided early and sustained improvement in vision in patients with branch RVO and central RVO, meeting the primary endpoint of noninferior 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.

Additional longer-term data up to 72 weeks showed that approximately 60% of patients receiving Vabysmo in BALATON and approximately 48% of patients in COMINO were able to extend their treatment intervals to 3 or 4 months apart. The company noted that current available treatments for RVO are typically given every 1 to 2 months. In both studies, Vabysmo was well tolerated, and the safety profile was consistent with previous studies.

Vabysmo was first approved for RVO in the United States by the FDA in October 2023. In Japan, it was approved by the Ministry of Health, Labor, and Welfare in March 2024, stated Roche.