Roche’s RHONE-X extension study of Vabysmo meets all primary endpoints to treat diabetic macular edema

Roche has unveiled four-year data from the RHONE-X extension study, revealing that Vabysmo (faricimab) was well-tolerated in diabetic macular edema (DME) patients. The study demonstrated that Vabysmo preserved vision, reduced retinal fluid, and allowed longer intervals between treatments. These results were shared at the ASRS 2024 Annual Meeting in Stockholm.

The RHONE-X study, the largest long-term dataset for DME, showed that nearly 80% of participants extended their treatment intervals to every three or four months. Over 90% achieved absence of DME, with central subfield thickness (CST) below 325 microns.

Vabysmo is approved in nearly 100 countries for DME and neovascular age-related macular degeneration (nAMD), with over four million doses distributed since its 2022 US approval.

The study, involving 1,474 patients from previous phase III trials, focused on long-term safety and efficacy. Roche also has ongoing and upcoming studies exploring Vabysmo’s effectiveness in various patient groups.