Roche announces long-term data from diabetic macular oedema treatment trial

Roche has released four-year results from the RHONE-X extension study, which assessed the long-term safety and efficacy of Vabysmo (faricimab) for diabetic macular edema (DME). This multicenter study involved 1,474 patients who had previously been treated with Vabysmo or aflibercept in the Phase III YOSEMITE or RHINE studies. During RHONE-X, all patients were given Vabysmo on a personalized schedule.

The study met its primary endpoints, showing that Vabysmo was well-tolerated and safe over four years. It also effectively maintained vision, reduced retinal fluid, and extended treatment intervals. Over 90% of patients achieved an absence of DME, with central subfield thickness below 325 microns.

Vabysmo is approved in about 100 countries for DME and wet age-related macular degeneration, and is also used for macular edema following retinal vein occlusion. Over four million doses have been distributed globally since its U.S. approval in 2022.