Early Macular Leakage Resolution Is Associated with Extended Faricimab Dosing in Retinal Vein Occlusion: A BALATON/COMINO Post Hoc Analysis

Macular leakage (ML) is a biomarker of disease activity and, in retinal vein occlusion (RVO), is associated with poor vision outcomes. Faricimab, a dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor (VEGF)-A inhibitor, has demonstrated efficacy and durability in RVO. This post hoc analysis of BALATON/COMINO examined the association between week 24 ML resolution and extended faricimab dosing intervals and vision outcomes achieved at week 68 in patients with RVO. BALATON and COMINO (NCT04740905/NCT04740931) were identically designed, phase 3, randomized trials that evaluated the efficacy and safety of faricimab in patients with branch or central/hemiretinal RVO, respectively. Patients initially received faricimab 6 mg every 4 weeks (Q4W) or aflibercept 2 mg Q4W; then from weeks 24–72, all patients received faricimab 6 mg up to Q16W according to a modified treat-and-extend regimen. This analysis included patients who remained in the study at week 68 and had a fluorescein angiography ML reading at week 24. Among 989 patients, 502 had ML resolution (≤ 1 mm2) and 143 had high ML (≥ 10 mm2) at week 24. The proportion of patients who achieved ≥ Q12W faricimab dosing at week 68 was higher among those with ML resolution at week 24 versus those with high ML at week 24 (56.1% vs 38.0%, p = 0.0001). The odds of patients receiving ≥ Q12W faricimab dosing at week 68 were higher among those with ML resolution than among those with high ML at week 24 (odds ratio 2.46, p < 0.001). Patients with ML resolution experienced greater vision gains at week 68 versus patients with high ML at week 24 (18.8 vs 15.0 letters, p = 0.0036). ML resolution at week 24 was associated with extended faricimab dosing intervals and improved vision at week 68 in patients with RVO in the BALATON/COMINO clinical trials. NCT04740905, NCT04740931. In people with retinal vein occlusion, a vein that carries blood away from the eye is blocked. This causes blood and other fluid to leak into the eye, a symptom known as ‘macular leakage.’ Macular leakage can cause blurred vision and vision loss. Faricimab and aflibercept are medicines injected into the eye to treat retinal vein occlusion. Faricimab can reduce macular leakage and improve vision. In this study, people with retinal vein occlusion received faricimab or aflibercept for 24 weeks and then faricimab from week 24 to week 72. This analysis investigated whether people who had low macular leakage after 24 weeks (1) were able to increase the time between faricimab injections as the study progressed and (2) had more vision improvement later in the study. After 24 weeks of treatment with either faricimab or aflibercept, 502 people had low macular leakage, while 143 people had high macular leakage. People with low macular leakage at week 24 could go longer between faricimab injections by week 68 than people with high macular leakage. In fact, people with low macular leakage at week 24 had more than two times the odds of receiving faricimab just once every 12 or 16 weeks by week 68 of the study. These people also had more vision improvement at week 68 than people with high macular leakage. These results show that people with retinal vein occlusion who have early improvements in macular leakage may have longer-lasting benefits, including needing less frequent faricimab injections and better vision. An infographic is available with this article.