Genentech announces new 72-week data from BALATON, COMINO studies

Genentech, a member of Roche, announced new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo in macular edema due to branch and central retinal vein occlusion. Whereas available RVO treatments are typically given every one to two months, the data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to three or four months apart. In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year. Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision. In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies. Results will be presented virtually on February 3 at Angiogenesis, Exudation, and Degeneration 2024, organized by Bascom Palmer Eye Institute in Florida. Both studies evaluated the average change in best-corrected visual acuity, or BCVA, score from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness, or CST. Reductions in CST indicate improvement. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks. At 72 weeks, people receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart, while people switched from aflibercept to Vabysmo gained 18.8 letters. During the first 24 weeks, vision gains were +16.8 eye chart letters in people receiving Vabysmo and +17.5 letters in people receiving aflibercept. At 72 weeks, people receiving Vabysmo as a first-line treatment saw a 310.9 microm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 307 microm. During the first 24 weeks of the study, CST reductions were 314.5 microm in people receiving Vabysmo and 307.6 microm in people receiving aflibercept. People receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks, while people switched from aflibercept to Vabysmo gained 17.1 eye chart letters. During the first 24 weeks of the study, vision gains were +16.9 eye chart letters in people receiving Vabysmo and +17.3 letters in people receiving aflibercept. People receiving Vabysmo as a first-line treatment saw a 465.9 microm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 460.6 microm at 72 weeks. During the first 24 weeks of the study, reductions in CST were 462.3 microm in people receiving Vabysmo and 447.8 microm in people receiving aflibercept.