Objective:
To evaluate the efficacy and safety of faricimab in patients with macular edema due to retinal vein occlusion (RVO) over a 72-week period.
Approach:
- Study Design: Phase III BALATON and COMINO trials enrolled over 1,280 treatment-naïve patients with branch or central/hemiretinal RVO, comparing monthly faricimab to aflibercept and using a modified treat-and-extend regimen.
Key Findings:
- Both trials showed durable vision improvements and anatomical benefits at week 72.
- Average improvements in best-corrected visual acuity (BCVA) were +18.1 (BALATON) and +18.8 (prior aflibercept) letters, and +16.9 (COMINO) and +17.1 (prior aflibercept) letters.
- Central subfield thickness (CST) reductions were over 300 µm in BALATON and over 460 µm in COMINO.
- 57% of patients in BALATON and 46% in COMINO achieved extended dosing intervals by week 68.
- Faricimab was well tolerated with low rates of ocular adverse events and no new safety concerns.
Interpretation:
Conclusion:
Sources:
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