Resolution of Angiographic Macular Leakage with Faricimab Versus Aflibercept in Patients with Diabetic Macular Edema in YOSEMITE/RHINE.

Autor:	Goldberg RA; Bay Area Retina Associates, Walnut Creek, California, USA. Electronic address: rgoldberg.eyemd@gmail.com., Mar FA; Genentech, Inc., South San Francisco, California, USA., Csaky K; Retina Foundation of the Southwest, Texas, USA., Amador M; Genentech, Inc., South San Francisco, California, USA., Khanani AM; Sierra Eye Associates and University of Nevada, Reno School of Medicine, Reno, Nevada, USA., Gibson K; Roche Products Ltd., Welwyn Garden City, UK., Kolomeyer AM; NJ Retina, New Brunswick, New Jersey, USA., Sim DA; Genentech, Inc., South San Francisco, California, USA., Murata T; Department of Ophthalmology, Shinshu University, Nagano, Japan., Wang T; F. Hoffmann-La Roche Ltd., Mississauga, Ontario, Canada., Udaondo P; Fundación Aiken de la Comunitat Valenciana; Hospital Universitario y Politécnico La Fe, Valencia, Spain., Souverain A; F. Hoffmann-La Roche Ltd., Basel, Switzerland., Shildkrot YE; RetinaCare of Virginia, Fishersville and Virginia Commonwealth University, Richmond, Virginia, USA., Vujosevic S; Department of Biomedical Surgical and Dental Sciences University of Milan, Milan, Italy; Eye Clinic, IRCCS MultiMedica, Milan, Italy., Nudleman E; Shiley Eye Institute, University of California, San Diego, La Jolla, California, USA., Sivaprasad S; NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, London, UK.
Jazyk:	angličtina
Zdroj:	Ophthalmology. Retina [Ophthalmol Retina] 2024 Nov 21. Date of Electronic Publication: 2024 Nov 21.
DOI:	10.1016/j.oret.2024.11.015
Abstrakt:	Purpose: To evaluate if dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor-A (VEGF-A) inhibition with faricimab resulted in greater macular leakage resolution versus aflibercept in patients with diabetic macular edema (DME). Design: Post hoc analysis of macular leakage assessments prespecified in the YOSEMITE/RHINE (NCT03622580/NCT03622593) phase 3 trials. Participants: Adults with visual acuity loss due to center-involving DME. Methods: Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg according to a personalized treat-and-extend-based regimen (T&E), or aflibercept 2.0 mg Q8W. This analysis included the first 16 weeks (head-to-head dosing period) when all patients received assigned study drug Q4W; patients were assessed 4 weeks after receiving 4 doses of assigned study drug Q4W. Main Outcome Measures: Macular leakage area on fluorescein angiography assessed by a reading center; proportion of patients with resolution of macular leakage (defined as macular leakage area 0-1 mm 2 ) and high macular leakage (defined as macular leakage area ≥ 10 mm 2 ) at baseline and week 16; and the proportion of faricimab T&E patients receiving Q16W dosing at week 52 among those with resolution of and high macular leakage at week 16. Results: Among patients with macular leakage data available at baseline, there were 1216 patients in the pooled faricimab (Q8W + T&E) arms and 593 patients in the aflibercept arm. Baseline median macular leakage area was similar between the faricimab (24.6 mm 2 ) and aflibercept arms (25.6 mm 2 ). At week 16, median macular leakage area was 3.6 mm 2 with faricimab versus 7.6 mm 2 with aflibercept (nominal P < 0.0001). More faricimab-treated patients (28%) achieved resolution of macular leakage versus aflibercept at week 16 (15%; nominal P < 0.0001). In the faricimab T&E arm, 63% of patients with resolution of macular leakage and 45% of patients with high macular leakage at week 16 achieved Q16W dosing at week 52 (nominal P < 0.01). Conclusions: Faricimab demonstrated greater macular leakage resolution versus aflibercept during head-to-head dosing. These findings suggest that dual Ang-2/VEGF-A inhibition promotes vascular stability beyond VEGF inhibition alone, supporting faricimab's potential to offer greater disease control and extend durability for patients with DME. (Copyright © 2024. Published by Elsevier Inc.)
Databáze:	MEDLINE
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