Clinical Studies:
BALATON / COMINO
Citation: Tadayoni, Ramin et al. Ophthalmology, Volume 131, Issue 8, 950 - 960.
Key Points
- BALATON and COMINO met their primary endpoint of faricimab non-inferiority to aflibercept through 24 weeks in treatment-naive patients with foveal center-involving macular edema secondary to branch and central/hemi-retinal vein occlusion, respectively.
- Faricimab was well tolerated, with a safety profile comparable to aflibercept and consistent with prior studies (YOSEMITE/RHINE, TENAYA/LUCERNE).
- Visual and anatomic outcomes were similar between faricimab and aflibercept arms in both trials.
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Objective
To evaluate the efficacy and safety of combination Ang-2/VEGF inhibitor faricimab versus aflibercept in patients with retinal vein occlusion (RVO).
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Study Design
Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group interventional clinical trials.
Subjects
- Inclusion criteria:
- Age at least 18 years
- Treatment-naive
- Foveal center-involving macular edema due to BRVO (BALATON) or CRVO/HRVO (COMINO)
- Visual acuity 73 to 19 ETDRS letters
- CST at least 325 microns
- Exclusion criteria:
- Prior/current treatment (anti-VEGF, steroids, etc.)
- Macular/pan-retinal laser
- Macular neovascularization
- Vitreomacular interface abnormalities
Randomization Scheme/Study Interventions
- Part 1: Randomized 1:1 to intravitreal faricimab 6 mg or aflibercept 2 mg every 4 weeks for 24 weeks.
- Part 2: All patients received faricimab 6 mg every 4–16 weeks on a modified treat-and-extend regimen until week 72.
Endpoints & Outcomes
- Primary: Change in BCVA (ETDRS letters) from baseline to week 24.
- Secondary:
- Change in CST from baseline over time (through week 24)
- Proportion of patients gaining or avoiding loss of ≥ 15, 10, 5, or 0 letters (through week 24)
- Proportion achieving ≥ 84 letters (20/20), 20/40 or better, and 20/200 or worse (through week 24)
- Incidence/severity of ocular and non-ocular adverse events
Results
- BALATON: 553 patients with BRVO (276 faricimab, 277 aflibercept). BCVA change at week 24: +16.9 (faricimab) vs. +17.5 (aflibercept). CST change: −311.4 μm (faricimab) vs. −304.4 μm (aflibercept). 56–60% gained ≥ 15 letters; 99% avoided BCVA loss of ≥ 15 letters in both arms.
- COMINO: 729 patients with CRVO/HRVO (366 faricimab, 363 aflibercept). BCVA change at week 24: +16.9 (faricimab) vs. +17.3 (aflibercept). CST change: −461.6 μm (faricimab) vs. −448.8 μm (aflibercept). 57–58% gained ≥ 15 letters; 96% avoided BCVA loss of ≥ 15 letters in both arms.
- Faricimab was well tolerated; ocular AE rates similar between arms (BALATON: 16% vs. 20%; COMINO: 23% vs. 28%).
Conclusions
- BALATON and COMINO each met their primary endpoint of faricimab non-inferiority to aflibercept through 24 weeks in treatment-naive patients with foveal center-involving macular edema secondary to branch and central/hemi-retinal vein occlusion, respectively.
- Faricimab was well tolerated, with a safety profile comparable to aflibercept and consistent with prior studies.