FX.co ★ Roche's Vabysmo Shows Long-Term Durability, Efficacy, Safety In Diabetic Macular Edema Study

Roche (RHHBY) has released promising four-year data from the RHONE-X extension study, which assessed the efficacy and safety of Vabysmo (faricimab) in patients with diabetic macular edema (DME). The study met all primary endpoints, demonstrating that Vabysmo was well-tolerated over the long term.

Notably, exploratory results revealed that Vabysmo not only preserved vision and reduced retinal fluid accumulation, which can impair sight, but also enabled extended intervals between treatments for individuals with DME. Impressively, 90% of patients exhibited no signs of DME after four years of Vabysmo treatment, indicating significant long-term benefits for those affected by this condition.

Further analysis indicated that by the end of the four-year period, nearly 80% of participants had successfully extended their treatment intervals to every three or four months. Moreover, patients maintained the vision improvements and retinal fluid reduction initially achieved during the Phase III YOSEMITE and RHINE studies.

In a pre-specified exploratory endpoint, over 90% of individuals treated with Vabysmo achieved absence of DME, defined as central subfield thickness (CST) of less than 325 microns—a key measure of retinal swelling due to fluid accumulation caused by unstable, leaky blood vessels. A reduction in CST signifies effective retinal drying and management of DME.