Faricimab Confirmed Safe for Treatment of Retinal Vein Occlusion

A recent study reaffirmed the safety and efficacy of using faricimab to treat macular edema due to retinal vein occlusion (RVO) by reducing vascular endothelial growth factor (VEGF). The study was a secondary phase of the BALATON and COMINO trials, which met their primary endpoints of faricimab noninferiority to aflibercept at week 24.1

These sustained increases seen with faricimab have not been seen in earlier central/hemiretinal RVO anti-VEGF trials. The COPERNICUS trial in particular exhibited diminished anatomic and visual improvements over the course of weeks 24 to 52.2

“To our knowledge, this report from BALATON/COMINO is the first to document vision and anatomical improvements have been maintained for more than 1 year in a global, randomized, phase 3 study in patients with [branch RVO] and [central RVO],” wrote Carl J. Danzig, MD, FASRS, Rand Eye Institute, and colleagues. “Furthermore, faricimab was well tolerated in patients with RVO, with a safety profile that was consistent with that established for other approved faricimab indications.”1

The study, a single-arm treatment period that took place after the randomized, double-masked, active comparator-controlled third phase of BALATON/COMINO trials, was comprised of 553 patients with treatment-naïve foveal center-involved macular edema due to branch (BALATON) RVO and 729 with central/hemiretinal (COMINO) RVO.1

Patients were ≥18 years of age or older, and each had a best-corrected visual acuity (BCVA) of 73 to 19 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and a central subfield thickness (CST) of ≥325 μm. Only 1 eye per patient was selected for study. Each of the patients was treated with faricimab according to modified treat-and-extend based dosing regimens.1

The team sought to measure changes from the baseline through week 72 in both BCVA and CST. The study was separated into 2 parts; the first saw patients randomly assigned to intravitreal injections of either faricimab 6.0 mg or aflibercept 2.0 mg every 4 weeks (Q4W) up to week 20. Following this, part 2 saw patients given faricimab 6.0 mg based on an edited treat-and-extend regimen, which was stricter than that imposed during BALATON/COMINO. These dosing intervals were either maintained or adjusted Q4W-Q16W based on CST and BCVA changes noted during visits.1

By the end of the study, Danzig and colleagues found that BCVA gains made by week 24 of BALATON/COMINO were maintained through week 72. Over weeks 64, 68, and 72, mean BCVA changes for BALATON participants were +18.1 ETDRS letters (95.03% CI, 16.9 to 19.4) for prior faricimab Q4W and +18.8 ETDRS letters (95.03% CI, 17.5 to 20.0) in prior aflibercept Q4W. Mean changes for COMINO participants in the same time frame were +16.9 letters (95.03% CI, 15.2 to 18.6) and +17.1 letters (95.03% CI, 15.4 to 18.8) for prior faricimab and prior aflibercept Q4W, respectively.1

Adjusted mean CST changes from baseline averaged over weeks 64, 68, and 72 were -310.9 μm (95.03% CI, -315.6 to -306.3) for prior faricimab Q4W and -307.0 μm (95.03% CI, -311.7 to -302.3) for prior aflibercept Q4W in BALATON. In COMINO, prior faricimab Q4W changes were -465.9 μm (95.03% CI, -472.5 to -459.3) and prior aflibercept Q4W changes were -460.6 μm (95.03% CI, -467.2 to -453.9).1

In prior faricimab and aflibercept Q4W arms, 64.1% and 56.9% of patients in BALATON and 45.5% and 50.1% of COMINO patients, respectively, were on ≥Q12W dosing at week 68.1

Despite switching from the intensive treatment phase of the initial BALATON/COMINO trial to the treat-and-extend phase, Danzig and colleagues established robust BCVA gains and CST reductions which were maintained through all 72 weeks of the study. Danzig and colleagues believe this study represents strong evidence in support of the continued use of faricimab against VEGF and RVO.

“These findings support the sustained efficacy and safety of faricimab in patients with RVO up to 72 weeks, with the potential for a reduced treatment burden due to durability of response,” wrote Danzig and colleagues.1

References

1. Danzig CJ, Dinah C, Ghanchi F, et al. Faricimab Treat-and-extend dosing for macular edema due to retinal vein occlusion: 72-week results from the Balaton and Comino Trials. Ophthalmology Retina. Published online March 17, 2025. doi:10.1016/j.oret.2025.03.005

2. Heier JS, Clark WL, Boyer DS, et al. Intravitreal AFLIBERCEPT injection for macular edema due to central retinal vein occlusion. Ophthalmology. 2014;121(7). doi:10.1016/j.ophtha.2014.01.027