Roche has reported positive data from the Phase III BALATON and COMINO clinical trials of Vabysmo (faricimab) to treat retinal vein occlusion (RVO).
The two double-masked, multicentre, randomised, international Phase III trials are designed to assess the safety and efficacy of Vabysmo against aflibercept.
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The BALATON trial is being carried out in 553 branch retinal vein occlusion (BRVO) patients, and the COMINO trial in 729 central retinal or hemiretinal vein occlusion (CRVO) patients.
Findings from both trials demonstrated that the Vabysmo treatment resulted in early and sustained vision improvement.
Vabysmo also met the primary endpoint of non-inferior visual acuity gains compared to aflibercept treatment. Its safety profile was found to be consistent with the previous trials.
The two trials demonstrated that more patients treated with Vabysmo had an absence of blood vessel leakage in the retina compared to patients treated with aflibercept in a pre-specified exploratory endpoint.
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By GlobalDataRoche chief medical officer and global product development head Levi Garraway said: “These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion.
“As these positive data continue to accrue, we believe Vabysmo may redefine the standard of care for multiple types of retinal conditions that can cause blindness.”
The company intends to submit the data from the BALATON and COMINO trials to health authorities worldwide, including European Medicines Agency and the US Food and Drug Administration (FDA), for approval to treat macular oedema caused due to RVO.
If approved, RVO will become the third indication for Vabysmo besides diabetic macular oedema and neovascular or ‘wet’ age-related macular degeneration.
Prior to this development, Roche reported positive data from the global Phase III COMMODORE 2 study of crovalimab in paroxysmal nocturnal haemoglobinuria (PNH) patients.
