A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Summary
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Timeline
- Start
- 2021-03-02
- Primary completion
- 2022-08-09
- Completion
- 2023-07-12
Outcome
Met primary endpoint
paper The BCVA gains from the baseline to week 24 with faricimab were noninferior versus aflibercept in BALATON PMID 38280653 ↗
release “Both studies met their primary endpoint, with Vabysmo showing non-inferior visual acuity gains compared to aflibercept.” gene.com ↗
release “Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO” roche.com ↗
Publications
- Danzig CJ, Dinah C, Ghanchi F, Hattenbach LO, Khanani AM, Lai TYY, Shimura M, Abreu F, Arrisi P, Liu Y, Paris LP, Retiere AC, Willis JR, Schlottmann PG; BALATON and COMINO Investigators. Faricimab Treat-and-Extend Dosing for Macular Edema Due to Retinal Vein Occlusion: 72-Week Results from the BALATON and COMINO Trials. Ophthalmol Retina. 2025 Sep;9(9):848-859. doi: 10.1016/j.oret.2025.03.005. Epub 2025 Mar 17.
- Tadayoni R, Paris LP, Danzig CJ, Abreu F, Khanani AM, Brittain C, Lai TYY, Haskova Z, Sakamoto T, Kotecha A, Schlottmann PG, Liu Y, Seres A, Retiere AC, Willis JR, Yoon YH; BALATON and COMINO Investigators. Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials. Ophthalmology. 2024 Aug;131(8):950-960. doi: 10.1016/j.ophtha.2024.01.029. Epub 2024 Jan 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Faricimab | Monoclonal antibody | 6 mg | Intravitreal |