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Clinical Trial
. 2025 Nov 1;45(11):2003-2011.
doi: 10.1097/IAE.0000000000004572.

IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS

Glenn J Jaffe  1 , Gábor Deák  2 , Kara Gibson  3 , Rahul N Khurana  4 , Eric Nudleman  5 , Yuichiro Ogura  6 , Ursula Schmidt-Erfurth  2 , Tracey Wang  7 , Peter D Westenskow  8 , David Wong  9 , Glenn Yiu  10 , Jeffrey R Willis  11
Affiliations
Clinical Trial

IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS

Glenn J Jaffe et al. Retina. .

Abstract

Background/purpose: To assess the effects of faricimab versus aflibercept on epiretinal membrane (ERM) formation in eyes with diabetic macular edema.

Methods: Post hoc analysis of phase 3 YOSEMITE/RHINE trial data in eyes with diabetic macular edema receiving faricimab every 8 weeks (Q8W), faricimab treat-and-extend (T&E; up to Q16W depending on central subfield thickness and best-corrected visual acuity), or aflibercept Q8W for 100 weeks.

Results: ERMs developed in 3.8% (23/602) of eyes treated with faricimab Q8W, 5.1% (31/608) with faricimab T&E, and 7.6% (45/590) with aflibercept Q8W at 100 weeks. ERMs were less likely with faricimab Q8W versus aflibercept Q8W (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.29-0.81, P = 0.0055). The mean (SD) best-corrected visual acuity at 100 weeks in eyes with and without ERMs were 69.2 (13.6) letters [20/40 Snellen] versus 73.8 (13.1) [20/40 Snellen], respectively; the mean (SD) CSTs were 315.8 (99.2) versus 274.6 (74.1) µ m. Faricimab T&E dosing intervals were extended ≥ Q12W in 79.7% of eyes without ERMs versus 50.0% with ERMs.

Conclusion: Risk of ERMs was 52% lower with faricimab Q8W versus aflibercept Q8W over 100 weeks in eyes with diabetic macular edema, suggesting a potential role for faricimab in reducing pre-retinal fibrotic proliferation. The results may help inform physician/patient decision-making when initiating intravitreal therapy.

Trial registration: NCT03622580 and NCT03622593.

Keywords: angiopoietin-2; diabetic macular edema; epiretinal membrane; faricimab; vascular endothelial growth factor-A.

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Conflict of interest statement

G. J. Jaffe: consultant—4D Molecular Therapeutics, Adverum, Annexon, Boehringer Ingelheim, EyePoint Pharmaceuticals, Kriya Therapeutics, Neurotech Pharmaceuticals Inc., Ocular Therapeutix, Regeneron, Ripple Therapeutics, Roche/Genentech, Inc. G. Deák: None. K. Gibson: employee—Roche Products Ltd. R. N. Khurana.: consultant—AbbVie, Bausch + Lomb, Clearside, Genentech, Inc., NGM Bio, Opthea, Regeneron, and RegenxBio; and has received research funding from Annexion, Apellis, Clearside Biomedical, EyePoint Pharmaceuticals, Genentech, Inc., NGM Bio, Opthea, Oxurion, and RegenxBio. E. Nudleman: consultant—Alcon, Allergan/AbbVie, EyeBio, Genentech, Inc. Y. Ogura: consultant—Alcon Japan, Apellis, Astellas, Bayer, Boehringer Ingelheim, Chengdu Kanghong, Chugai Pharmaceutical Co., Ltd., HOYA, Iveric Bio, Kyoto Drug Discovery & Development, Novartis, Senju, and Wakamoto; Lecture fees—Bayer, KOWA, NIKON Healthcare, Novartis, Santen, Sanwa Kagaku, Topcon, and ZEISS; former employee—Genentech, Inc. U. Schmidt-Erfurth: consultant—Apellis, Astellas, Aviceda, Complement Therapeutics, Heidelberg Engineering, Novartis, ONL Therapeutics, RetInSight, Roche, Topcon, Genentech, Kodiak. T. Wang, P. D. Westenskow: employee—F. Hoffmann-La Roche Ltd. D. Wong: consultant—AbbVie, Alcon, Apellis, Bausch Health, Bayer, Biogen, Novartis, Regeneron, Ripple, Roche, ZEISS; Grants; Bayer, Novartis, Roche. G. Yiu: consultant—4D Molecular Therapeutics, AbbVie, Adverum, Alimera, Bausch + Lomb, Boehringer Ingelheim, Clearside Biomedical, Endogena, Genentech, Inc., Gyroscope Therapeutics, Iridex, Janssen, jCyte, Myrobalan, NGM Bio, Novartis, Ocuphire, Ray Therapeutics, Regeneron, RegenxBio, Stealth BioTherapeutics. J. R. Willis: employee—Genentech, Inc.

Figures

Fig. 1.
Fig. 1.
Patient flow diagram for the post hoc analysis of ERM formation in the phase 3 YOSEMITE and RHINE trials.
Fig. 2.
Fig. 2.
Cumulative proportion of eyes without ERMs at baseline that developed ERMs after 1 and 2 years (weeks 52 and 100) (ERM analysis population).
Fig. 3.
Fig. 3.
A. BCVA. B. CST. C. Proportion of eyes with IRF and SRF, and D, macular leakage at baseline and year 2 (week 96 or 100) in eyes with and without ERM formation (ERM analysis population).
Fig. 4.
Fig. 4.
Proportion of eyes in the faricimab T&E arm on each treatment interval at year 2 (week 96) among eyes with and without ERM formation during the study (ERM analysis population).
None
None
See this image and copyright information in PMC

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