OBJECTIVES: In the BALATON and COMINO trials monthly dosing (Q4W) of faricimab or aflibercept 2mg was investigated in macular edema secondary to retinal vein occlusion (RVO). At the week 24 primary endpoint, all patients were switched to a faricimab T&E regimen until week 72. Based on the results from BALATON and COMINO the objective of this research was to evaluate the comparative efficacy and safety of faricimab relative to other treatment regimens currently in use for monotherapies of RVO.

METHODS: A systematic literature review was conducted to identify randomized controlled trials with relevant treatments in RVO. Outcomes including mean change from baseline at week 24 in best corrected visual acuity (BCVA) and central retinal thickness (abbreviated CST) as well as the proportion of patients with ocular adverse events (OAE) were analyzed using a Bayesian network meta-analysis.

RESULTS: Of the 39 studies identified, 20 were considered sufficiently homogenous to allow outcome comparisons vs. aflibercept, ranibizumab and bevacizumab applied Q4W or as needed (Pro re nata = PRN). Point estimates for mean change from baseline in BCVA were numerically greater for faricimab Q4W compared with all anti-VEGF treatments except for aflibercept 2mg Q4W with credible intervals (CI) including zero. The probability of faricimab Q4W being non-inferior (-4 letters) to anti-VEGF comparators was between 90% and 99%. Point estimates for mean change from baseline in CST were numerically greater for faricimab Q4W compared with all anti-VEGF treatments with most CIs including zero and statistically greater compared to bevacizumab given PRN. Results for OAEs indicated a comparable safety profile with wide CIs.

CONCLUSIONS: The results indicate that faricimab is associated with non-inferior vision changes and comparable or numerically greater retinal drying vs. anti-VEGF treatments. The results also suggest that the safety profile for faricimab is comparable to other anti-VEGFs, which have well-established safety profiles.