Published last month in Ophthalmology Retina, a study has presented promising 72-week data from the phase III BALATON and COMINO trials on faricimab. The trials indicate that faricimab – a bispecific antibody targeting both VEGF-A and Angiopoietin-2 – provides durable vision improvements and anatomical benefits in patients with macular edema due to retinal vein occlusion (RVO), with the added advantage of reducing treatment burden.
The two trials enrolled over 1,280 treatment-naïve patients with branch (BALATON) or central/hemiretinal (COMINO) RVO. Following an initial phase comparing monthly faricimab to aflibercept, all participants received faricimab using a modified treat-and-extend (T&E) regimen from week 24 to week 72. This approach adjusted injection frequency between every four to 16 weeks based on changes in visual acuity and retinal thickness.
By week 72, both groups maintained the vision gains and central subfield thickness (CST) reductions seen at week 24. Average improvements in best-corrected visual acuity (BCVA) were +18.1 (prior faricimab) and +18.8 (prior aflibercept) ETDRS letters in BALATON, and +16.9 (prior faricimab) and +17.1 (prior aflibercept) letters in COMINO. CST reductions were similarly durable, with decreases of over 300 µm in BALATON and over 460 µm in COMINO.
Notably, nearly half of patients (57 percent in BALATON and 46 percent in COMINO) achieved extended dosing intervals by week 68, demonstrating faricimab’s extended durability. Most patients maintained these extended intervals without needing to revert to more frequent injections. Safety outcomes also remained favorable – faricimab was well tolerated, with low rates of ocular adverse events and inflammation, and no new safety concerns emerging over the extended follow-up period.
The study marks the first global phase III trial to show sustained vision and anatomical improvements beyond one year in both branch and central RVO using a T&E regimen, supporting faricimab as a long-term treatment option offering both clinical effectiveness and reduced injection frequency.
