In the trial, patients treated with Vabysmo extended their treatment intervals up to every four months while maintaining the eyesight improvements made during the study's initial 24 weeks
Roche’s logo in Rotkreuz, Switzerland. (Credit: F. Hoffmann-La Roche Ltd)
Roche said that its Vabysmo (faricimab) has maintained vision improvements with extended treatment intervals of up to four months in Phase 3 BALATON and COMINO studies of patients with retinal vein occlusion (RVO).
Vabysmo is a bispecific antibody that targets and inhibits two signalling pathways linked to several vision-threatening retinal conditions.
Both global late-stage studies assessed extended treatment intervals with Vabysmo in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).
All participants in both studies received Vabysmo using a treat-and-extend dosage regimen from weeks 24 to 72. This allowed the customisation of treatment intervals as per each patient’s response to treatment.
According to the positive topline long-term results, patients treated with Vabysmo extended their treatment intervals up to every four months while maintaining the eyesight improvements made during the study’s initial 24 weeks.
From baseline up until week 72, the bispecific antibody showed substantial and sustained drying of retinal fluid as shown by a decrease in central subfield thickness.
According to Roche, the use of a personalised treat-and-extend dosage regimen in global Phase 3 studies has led to the first time that visual and anatomical benefits have been sustained for longer than a year.
Vabysmo was generally well-tolerated in both studies, and the safety profile was comparable with earlier trials.
Roche chief medical officer and global product development head Levi Garraway said: “These are the first retinal vein occlusion (RVO) studies to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch RVO.
“These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition.”
The BALATON trial was conducted in 553 BRVO people whereas the COMINO study was conducted in 729 CRVO people.
The primary endpoint was defined as the change in best-corrected visual acuity from baseline at 24 weeks.
On the other hand, key secondary endpoints included treatment durability at 68 weeks and continuation of weeks 0-24 endpoints.
The Swiss healthcare company has already submitted data up to 24 weeks to the US Food and Drug Administration (FDA) and European Medicines Agency.