In both studies, Vabysmo was found to be noninferior to aflibercept, with average vision gains being comparable between the treatment groups.
The Food and Drug Administration (FDA) has given the green light to Vabysmo (faricimab-svoa), a new treatment for macular edema following retinal vein occlusion (RVO). This approval is a significant step forward in the field of ophthalmology, offering patients a promising alternative to existing treatments.
- Vabysmo is a vascular endothelial growth factor and angiopoietin-2 inhibitor.
- The approval was based on data from the randomized, double-masked phase 3 BALATON and COMINO studies.
- These studies included 553 patients with macular edema due to branch RVO and 729 patients with macular edema secondary to central retinal or hemiretinal vein occlusion.
- Vabysmo was found to be noninferior to aflibercept, with average vision gains being comparable between the treatment groups.
- The most common adverse reaction reported was conjunctival hemorrhage (3%).
According to the American Academy of Ophthalmology, retinal vein occlusion affects about 16 million adults worldwide.
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