FDA clears faricimab for RVO

The Food and Drug Administration on April 9 cleared an updated Vabysmo label that lets Genentech treat macular edema after retinal vein occlusion beyond six months. (gene.com) (fda.gov) Retinal vein occlusion is a blocked vein in the retina, the light-sensing tissue at the back of the eye. The blockage can leak fluid into the macula, the center of sharp vision, and that swelling is what doctors are treating. (gene.com) Vabysmo, or faricimab-svoa, is injected into the eye and blocks two signaling pathways: vascular endothelial growth factor-A and angiopoietin-2. Genentech says those pathways are linked to leaky, unstable blood vessels and inflammation in retinal disease. (gene.com 1) (gene.com 2) The new FDA action is not a first-time approval for retinal vein occlusion. The agency first approved Vabysmo for macular edema following retinal vein occlusion on October 26, 2023. (gene.com) What changed in April 2026 is the dosing language. FDA’s approval letter says the supplement removes the prescribing-information language that had specified a six-month duration for monthly dosing in retinal vein occlusion. (fda.gov) The current prescribing information now lists the recommended retinal vein occlusion dose as 6 milligrams, or 0.05 milliliters, by intravitreal injection every four weeks. The highlights page flags this as a “Recent Major Change” dated April 2026. (fda.gov) The original 2023 approval was based on two Phase 3 studies, BALATON and COMINO. Genentech said those trials showed Vabysmo was non-inferior to aflibercept on vision gains at 24 weeks and produced rapid drying of retinal fluid. (gene.com) Those two studies enrolled 553 patients in BALATON, which covered branch retinal vein occlusion, and 729 in COMINO, which covered central or hemiretinal vein occlusion. A 72-week presentation reported that more than 45% of patients were on faricimab dosing intervals of at least every 12 weeks by week 68. (gene.com) Genentech said retinal vein occlusion affects more than 1 million Americans and often needs long-term intravitreal therapy because the disease is chronic. That is the practical backdrop for a label change focused on treatment beyond month six. (gene.com) The safety language did not disappear with the dosing update. The label and company materials still warn that intravitreal injections can cause endophthalmitis, retinal detachment, and other serious eye complications, and patients are told to seek care for pain, redness, light sensitivity, or vision loss. (gene.com) (fda.gov) For retina clinics, the April 2026 decision mainly changes how long Vabysmo can stay on-label in retinal vein occlusion care. It turns a six-month boundary into open-ended monthly treatment language, with the same 6 milligram injection still on the label. (fda.gov 1) (fda.gov 2)