FDA
FDA expands Vabysmo label for longer-term retinal vein occlusion treatment
Image source: DailyMed, U.S. Food and Drug Administration
On April 9, 2026, FDA approved an expanded label for Vabysmo (faricimab‑svoa), extending its use beyond six months for adults with macular edema secondary to retinal vein occlusion (RVO), a condition often requiring chronic therapy.
Commenting on the FDA action, Levi Garraway, MD, PhD, Genentech’s chief medical officer, said the updated label “should help minimize disruptive treatment switches in patients with RVO who are benefitting from Vabysmo,” highlighting how the approval may allow clinicians to maintain continuity of therapy in patients who are responding and require sustained intravitreal treatment over time.
Efficacy
The phase 3 BALATON and COMINO trials supported the original FDA approval of Vabysmo for the treatment of macular edema following RVO based on 24‑week primary efficacy outcomes. Evidence supporting continued use beyond six months comes from longer‑term follow‑up of these same trials. Patients who completed the initial 24‑week efficacy period continued to receive Vabysmo through week 72 using a treat‑and‑extend–based personalized dosing regimen, enabling assessment of durability with ongoing therapy. The longer‑term analyses showed that visual acuity gains and reductions in central subfield thickness achieved during the first six months were generally maintained over extended follow‑up, supporting FDA’s decision to allow treatment continuation beyond the initial six‑month period.
Safety
Longer‑term follow‑up from the BALATON and COMINO trials showed that Vabysmo remained well tolerated through 72 weeks in patients with macular edema following RVO. No new ocular or systemic safety signals were identified beyond the initial 24‑week period, and rates of intraocular inflammation, retinal vasculitis, thromboembolic events, and other adverse events were low and consistent with earlier findings and with Vabysmo's established safety profile in other retinal indications. Safety outcomes remained stable during extended treat‑and‑extend dosing, supporting continued therapy beyond six months in patients who respond to treatment.
Sources:
Genentech, Inc. (2026, April 9). FDA approves updated Vabysmo label to extend treatment for macular edema following retinal vein occlusion (RVO) beyond six months
Ghanchi F, et al. (2024 June). Investigative Ophthalmology & Visual Science. Efficacy, safety, and durability of faricimab in macular edema due to retinal vein occlusion: 72-week results from the BALATON and COMINO trials
Danzig CJ, et al. BALATON and COMINO Investigators. (2025, March 17). Ophthalmol Retina. Faricimab Treat-and-Extend Dosing for Macular Edema Due to Retinal Vein Occlusion: 72-Week Results from the BALATON and COMINO Trials