Roche announced positive new data from two global phase III studies, BALATON and COMINO, evaluating Vabysmo (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness.

The safety profile of Vabysmo was consistent with previous trials. Results will be presented virtually on 11 February at Angiogenesis, Exudation and Degeneration 2023, organised by the Bascom Palmer Eye Institute in Florida, United States. Neovascular or ‘wet' age-related macular degeneration (nAMD), diabetic macular edema (DME) and RVO together affect around 70 million people worldwide and are among the leading causes of vision loss.

Data from the BALATON and COMINO studies will be submitted to health authorities around the world, including the United States Food and Drug Administration and European Medicines Agency, for approval for the treatment of macular edema due to RVO. If approved, this would be the third indication for Vabysmo, which is currently approved in more than 50 countries to treat nAMD and DME. Vabysmo's efficacy and safety in nAMD and DME have been demonstrated by two-year data from four large, global studies involving more than 3,000 participants.

Vabysmo is the first bispecific antibody approved for the eye with phase III studies supporting treatment intervals of up to four months for people with these conditions. It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Globally, more than 450,000 Vabysmo doses have been distributed for treatment of these conditions to date.

In the BALATON and COMINO studies, patients were randomised 1:1 to receive six monthly injections of either Vabysmo®? (faricimab) (6.0 mg) or aflibercept (2.0 mg) for 20 weeks, with the primary endpoint measured at week 24. Both studies met their primary endpoint, with Vabysmo showing non-inferior visual acuity gains compared to aflibercept.

The average vision gains from baseline were comparable between the two treatments in both studies. In BALATON, vision gains were +16.9 eye chart letters in the Vabysmo arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the Vabysmo arm and +17.3 letters in the aflibercept arm at 24 weeks.

Additionally, the percentage of patients gaining 15 or more letters was comparable across treatment arms in both studies. Fluid in the retina in the back of the eye, which may result from blood vessel leakage, can cause swelling and blurry vision. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness (CST).

In both studies, reductions in CST were comparable across treatment arms. In BALATON, CST reductions were -311.4 µm in the Vabysmo arm and -304.4 µm in the aflibercept arm. In COMINO, CST reductions were -461.6 µm in the Vabysmo arm and -448.8 µm in the aflibercept arm. Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients as seen in a pre-specified exploratory endpoint.

In BALATON, one third of patients (34%) treated with Vabysmo had an absence of leakage compared to one fifth (21%) of aflibercept patients. In COMINO, the rates were 44% for Vabysmo patients versus 30% for aflibercept patients. In both studies, Vabysmo's safety profile was consistent with previous trials.

The most common adverse reaction was conjunctival haemorrhage (3%). Safety results were consistent across study arms. The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.