Early Macular Leakage Resolution Is Associated with Extended Faricimab Dosing in Retinal Vein Occlusion: A BALATON/COMINO Post Hoc Analysis
10 affiliations
- 1Ophthalmology Department, London North West University Healthcare, NHS Trust, Central Middlesex Hospital
- 2University of Illinois at Chicago
- 3Strathfield Retina Clinic
- 4Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center
- 5Retina Associates of Florida
- 6School of Medicine, Shanghai General Hospital, Shanghai Jiao Tong University
- 7Everest Clinical Research
- 8Genentech, Inc.
- 9F. Hoffmann-La Roche Ltd.
- 10The Advanced Retina Institute
Abstract
Introduction 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. Methods 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. Results 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). Conclusions 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. ClinicalTrials.gov Identifiers NCT04740905, NCT04740931. Graphical Abstract
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BibTeX
@article{dinah2026early,
title = {{Early Macular Leakage Resolution Is Associated with Extended Faricimab Dosing in Retinal Vein Occlusion: A BALATON/COMINO Post Hoc Analysis}},
author = {Christiana Dinah and Harit K. Bhatt and Hemal Mehta and Masahiko Shimura and Ivan J. Suner and Xun Xu and Nicholas Dagincourt and Liliana P. Paris and Joern Schweitzer and Carl J. Danzig},
journal = {Ophthalmology and Therapy},
year = {2026},
month = sep,
doi = {10.1007/s40123-026-01489-9},
url = {https://doi.org/10.1007/s40123-026-01489-9},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Early Macular Leakage Resolution Is Associated with Extended Faricimab Dosing in Retinal Vein Occlusion: A BALATON/COMINO Post Hoc Analysis
AU - Christiana Dinah
AU - Harit K. Bhatt
AU - Hemal Mehta
AU - Masahiko Shimura
AU - Ivan J. Suner
AU - Xun Xu
AU - Nicholas Dagincourt
AU - Liliana P. Paris
AU - Joern Schweitzer
AU - Carl J. Danzig
PY - 2026
DA - 2026/09/01
JO - Ophthalmology and Therapy
DO - 10.1007/s40123-026-01489-9
UR - https://doi.org/10.1007/s40123-026-01489-9
AB - Introduction 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. Methods 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. Results 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). Conclusions 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. ClinicalTrials.gov Identifiers NCT04740905, NCT04740931. Graphical Abstract
SN - 2193-8245
SN - 2193-6528
ER -