Genentech reports both BALATON, COMINO studies meet primary endpoint

Genentech, a member of Roche, announced new data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo in macular edema due to branch and central retinal vein occlusion 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 February 11 at Angiogenesis, Exudation, and Degeneration 2023, organized by Bascom Palmer Eye Institute in Florida. In the BALATON and COMINO studies, patients were randomized 1:1 to receive six monthly injections of either Vabysmo or aflibercept 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, or CST. In both studies, reductions in CST were comparable across treatment arms. In BALATON, CST reductions were -311.4 microm in the Vabysmo arm and -304.4 microm in the aflibercept arm. In COMINO, CST reductions were -461.6 microm in the Vabysmo arm and -448.8 microm 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 treated with Vabysmo had an absence of leakage compared to one-fifth 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 hemorrhage. 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.