Faricimab Treat-and-Extend Dosing for Macular Edema due to Retinal Vein Occlusion: 72-Week Results From the BALATON and COMINO Trials.

Abstract

Purpose: To assess the efficacy, durability, and safety of dual angiopoietin-2/vascular endothelial growth factor inhibition with faricimab dosed per a modified treat-and-extend (T&E)-based regimen in patients with retinal vein occlusion (RVO).

Design: Single-arm treatment period after a randomized, double-masked, active comparator-controlled period in the phase 3 BALATON/COMINO (NCT04740905/NCT04740931) trials.

Participants: Patients with treatment-naïve foveal center-involved macular edema due to branch (BALATON; N=553) or central/hemiretinal (COMINO; N=729) RVO.

Methods: Patients randomized to faricimab 6.0 mg every 4 weeks (Q4W) or aflibercept 2.0 mg Q4W up to week 20 received faricimab 6.0 mg dosed per a modified T&E-based regimen from week 24-72. Dosing frequency was adjusted Q4W-Q16W based on changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA).

Main outcome measures: Change from baseline through week 72 in BCVA and CST; durability and safety through week 72.

Results: Visual acuity gains and CST reductions achieved at week 24 were maintained through week 72. Adjusted mean BCVA (95.03% CI) changes from baseline averaged over weeks 64/68/72 in the prior faricimab Q4W and prior aflibercept Q4W arms were +18.1 letters (16.9 to 19.4) and +18.8 letters (17.5 to 20.0), respectively, in BALATON and +16.9 letters (15.2 to 18.6) and +17.1 letters (15.4 to 18.8), respectively, in COMINO. Adjusted mean (95.03% CI) CST changes from baseline averaged over weeks 64/68/72 in the prior faricimab Q4W and prior aflibercept Q4W arms were -310.9 μm (-315.6 to -306.3) and -307.0 μm (-311.7 to -302.3), respectively, in BALATON and -465.9 μm (-472.5 to -459.3) and -460.6 μm (-467.2 to -453.9), respectively, in COMINO. In the prior faricimab Q4W and prior aflibercept Q4W arms, 64.1% and 56.9% of patients from BALATON and 45.5% and 50.1% from COMINO, respectively, were on ≥Q12W dosing at week 68. Faricimab continued to be well tolerated from week 24-72; the safety profile was consistent with that established for diabetic macular edema and neovascular age-related macular degeneration.

Conclusions: These findings support the sustained efficacy and safety of faricimab in patients with macular edema due to RVO up to 72 weeks, with the potential for reduced treatment burden due to response durability.