1. Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials.
- Author
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Tadayoni R, Paris LP, Danzig CJ, Abreu F, Khanani AM, Brittain C, Lai TYY, Haskova Z, Sakamoto T, Kotecha A, Schlottmann PG, Liu Y, Seres A, Retiere AC, Willis JR, and Yoon YH
- Subjects
- Humans, Male, Female, Double-Blind Method, Middle Aged, Aged, Treatment Outcome, Angiopoietin-2 antagonists & inhibitors, Macular Edema drug therapy, Macular Edema etiology, Macular Edema physiopathology, Macular Edema diagnosis, Retinal Vein Occlusion drug therapy, Retinal Vein Occlusion complications, Retinal Vein Occlusion diagnosis, Retinal Vein Occlusion physiopathology, Visual Acuity physiology, Recombinant Fusion Proteins therapeutic use, Recombinant Fusion Proteins administration & dosage, Recombinant Fusion Proteins adverse effects, Receptors, Vascular Endothelial Growth Factor antagonists & inhibitors, Receptors, Vascular Endothelial Growth Factor therapeutic use, Angiogenesis Inhibitors therapeutic use, Angiogenesis Inhibitors adverse effects, Intravitreal Injections, Vascular Endothelial Growth Factor A antagonists & inhibitors, Tomography, Optical Coherence
- Abstract
Purpose: To evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A inhibitor faricimab versus aflibercept in patients with vein occlusion., Design: Phase 3, global, randomized, double-masked, active comparator-controlled trials: BALATON/COMINO (ClincalTrials.gov identifiers: NCT04740905/NCT04740931; sites: 149/192)., Participants: Patients with treatment-naïve foveal center-involved macular edema resulting from branch (BALATON) or central or hemiretinal (COMINO) RVO., Methods: Patients were randomized 1:1 to faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks for 24 weeks., Main Outcome Measures: Primary end point: change in best-corrected visual acuity (BCVA) from baseline to week 24. Efficacy analyses included patients in the intention-to-treat population. Safety analyses included patients who received ≥ 1 doses of study drug., Results: Enrollment: BALATON, n = 553; COMINO, n = 729. The BCVA gains from the baseline to week 24 with faricimab were noninferior versus aflibercept in BALATON (adjusted mean change, +16.9 letters [95.03% confidence interval (CI), 15.7-18.1 letters] vs. +17.5 letters [95.03% CI, 16.3-18.6 letters]) and COMINO (+16.9 letters [95.03% CI, 15.4-18.3 letters] vs. +17.3 letters [95.03% CI, 15.9-18.8 letters]). Adjusted mean central subfield thickness reductions from the baseline were comparable for faricimab and aflibercept at week 24 in BALATON (-311.4 μm [95.03% CI, -316.4 to -306.4 μm] and -304.4 μm [95.03% CI, -309.3 to -299.4 μm]) and COMINO (-461.6 μm [95.03% CI, -471.4 to -451.9 μm] and -448.8 μm [95.03% CI, -458.6 to -439.0 μm]). A greater proportion of patients in the faricimab versus aflibercept arm achieved absence of fluorescein angiography-based macular leakage at week 24 in BALATON (33.6% vs. 21.0%; nominal P = 0.0023) and COMINO (44.4% vs. 30.0%; nominal P = 0.0002). Faricimab was well tolerated, with an acceptable safety profile comparable with aflibercept. The incidence of ocular adverse events was similar between patients receiving faricimab (16.3% [n = 45] and 23.0% [n = 84] in BALATON and COMINO, respectively) and aflibercept (20.4% [n = 56] and 27.7% [n = 100], respectively)., Conclusions: These findings demonstrate the efficacy and safety of faricimab, a dual Ang-2/VEGF-A inhibitor, in patients with macular edema secondary to retinal vein occlusion., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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