Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
Faricimab: current evidence for the treatment of retinal vein occlusion.
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Vitiello Livio, Giannaccare Giuseppe, Borrelli Enrico, Coco Giulia, Chiosi Flavia, Lixi Filippo, Troisi Mario, Gagliardi Vincenzo, D'Aniello Eleonora, Pellegrino Alfonso, Iovino Claudio
Аннотация
PURPOSE: To provide an updated and critical overview of the available clinical evidence on the use of faricimab for the treatment of macular edema secondary to retinal vein occlusion (RVO), with particular focus on efficacy, durability of response, and clinical applicability in both trial and real-world settings.
METHODS: A systematic literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using PubMed and Scopus databases. Pivotal phase III randomized clinical trials and real-world studies evaluating intravitreal faricimab in patients with branch, central, or hemiretinal vein occlusion were included. Both treatment-naïve and previously treated eyes were considered. Evidence was qualitatively synthesized with attention to visual and anatomical outcomes, treatment durability, and safety.
RESULTS: Data from the BALATON and COMINO phase III trials demonstrated that faricimab achieved visual and anatomical outcomes comparable to aflibercept 2.0 mg during fixed monthly dosing, with maintenance of efficacy up to 72 weeks under treat-and-extend regimens. A clinically meaningful proportion of patients achieved extended treatment intervals, suggesting potential reduction in treatment burden. Real-world studies largely confirmed consistent anatomical efficacy across different RVO subtypes and clinical scenarios. However, functional improvement was more heterogeneous, particularly in chronic or therapy-resistant cases, where anatomical and visual outcomes were frequently dissociated, likely reflecting irreversible retinal ischemia or structural damage. Across studies, faricimab showed a generally favorable safety profile.
CONCLUSION: Available evidence supports faricimab as an effective and well-tolerated therapeutic option for RVO-related macular edema, especially when initiated early in the disease course. However, although extended dosing intervals were achieved in a proportion of patients, superiority in durability compared with other anti-VEGF agents has not yet been demonstrated. Further prospective, comparative, and long-term real-world studies are needed to better define patient selection criteria and the optimal positioning of faricimab within current RVO treatment algorithms.
METHODS: A systematic literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using PubMed and Scopus databases. Pivotal phase III randomized clinical trials and real-world studies evaluating intravitreal faricimab in patients with branch, central, or hemiretinal vein occlusion were included. Both treatment-naïve and previously treated eyes were considered. Evidence was qualitatively synthesized with attention to visual and anatomical outcomes, treatment durability, and safety.
RESULTS: Data from the BALATON and COMINO phase III trials demonstrated that faricimab achieved visual and anatomical outcomes comparable to aflibercept 2.0 mg during fixed monthly dosing, with maintenance of efficacy up to 72 weeks under treat-and-extend regimens. A clinically meaningful proportion of patients achieved extended treatment intervals, suggesting potential reduction in treatment burden. Real-world studies largely confirmed consistent anatomical efficacy across different RVO subtypes and clinical scenarios. However, functional improvement was more heterogeneous, particularly in chronic or therapy-resistant cases, where anatomical and visual outcomes were frequently dissociated, likely reflecting irreversible retinal ischemia or structural damage. Across studies, faricimab showed a generally favorable safety profile.
CONCLUSION: Available evidence supports faricimab as an effective and well-tolerated therapeutic option for RVO-related macular edema, especially when initiated early in the disease course. However, although extended dosing intervals were achieved in a proportion of patients, superiority in durability compared with other anti-VEGF agents has not yet been demonstrated. Further prospective, comparative, and long-term real-world studies are needed to better define patient selection criteria and the optimal positioning of faricimab within current RVO treatment algorithms.