Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials.

Autor:	Tadayoni R; Lariboisière and Fondation Adolphe de Rothschild Hospitals, Université Paris Cité, Paris, France. Electronic address: rtadayoni@for.paris., Paris LP; Genentech, Inc., South San Francisco, California., Danzig CJ; Rand Eye Institute, Deerfield Beach, Florida; Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Florida., Abreu F; Genentech, Inc., South San Francisco, California., Khanani AM; Sierra Eye Associates, Reno, Nevada; University of Nevada, Reno School of Medicine, Reno, Nevada., Brittain C; Genentech, Inc., South San Francisco, California., Lai TYY; Department of Ophthalmology and Visual Science, The Chinese University of Hong Kong, Hong Kong, New Territories, China., Haskova Z; Genentech, Inc., South San Francisco, California., Sakamoto T; Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan., Kotecha A; Roche Products Ltd., Welwyn Garden City, United Kingdom., Schlottmann PG; Charles Centro Oftalmologico, Buenos Aires, Argentina., Liu Y; Genentech, Inc., South San Francisco, California., Seres A; Budapest Retina Associates, Budapest, Hungary., Retiere AC; Roche Products Ltd., Welwyn Garden City, United Kingdom., Willis JR; Genentech, Inc., South San Francisco, California., Yoon YH; Department of Ophthalmology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2024 Aug; Vol. 131 (8), pp. 950-960. Date of Electronic Publication: 2024 Jan 26.
DOI:	10.1016/j.ophtha.2024.01.029
Abstrakt:	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.)
Databáze:	MEDLINE
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