This infographic summarises the design of two nearly identical phase 3 trials of faricimab, a dual angiopoietin-2/vascular endothelial growth factor-A inhibitor, in patients with macular edema due to retinal vein occlusion: BALATON (NCT04740905) and COMINO (NCT04740931). Patients were randomised to receive faricimab 6.0 mg or aflibercept 2.0 mg monthly from day 1 to week 24 to compare the efficacy of faricimab versus aflibercept. The primary endpoint at week 24 was the mean change from baseline in best-corrected visual acuity. From weeks 24 to 72, all patients received faricimab 6.0 mg according to a modified treat-and-extend based regimen, with dosing up to every 16-weeks to evaluate treatment durability.
Reference
Hattenbach L, et al. BALATON and COMINO: Phase III randomized clinical trials of faricimab for retinal vein occlusion: Study design and rationale. Ophthalmol Sci. 2023;3:100302.
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Funding was provided by F. Hoffmann-La Roche Ltd. for the study and third-party writing assistance, which was provided by Nicole Tom, PhD, of Envision Pharma Group.
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AC, AK, FK, IS: Provided critical review of the infographic.
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AC: Consultant: Alcon, Allergan, Apellis, Bayer, Novartis, Zeiss and Roche/Genentech Inc.; Grants or contracts from any entity: Allergan, Bayer, and Novartis; Payment or honoraria for lectures, presentations, speaker bureaus, or educational events: Alcon, Allergan, Apellis, Bayer, Nidek, Novartis, Zeiss, Roche/Genentech, Inc.; Support for attending meetings and/or travel: Bayer. AK: Employee: Roche Ltd. FK, IS: Employee: F. Hoffmann-La Roche Ltd.
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Chang, A., Kotecha, A., Kermani, F. et al. Infographic: study design of the BALATON and COMINO phase 3 randomised trials of faricimab in patients with retinal vein occlusion. Eye (2024). https://doi.org/10.1038/s41433-024-02936-2
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DOI: https://doi.org/10.1038/s41433-024-02936-2
