Genentech’s Vabysmo Proves Durable, Effective, and Safe in Long-Term Diabetic Macular Edema Study

Genentech, a member of the Roche Group, recently unveiled promising four-year data from the RHONE-X extension study, affirming the safety and efficacy of Vabysmo® (faricimab-svoa) in treating diabetic macular edema (DME). The study was presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden. The results indicate that Vabysmo not only maintained vision and reduced retinal fluid but also extended the intervals between treatments for patients.

Levi Garraway, M.D., Ph.D., Genentech's Chief Medical Officer, emphasized the significance of these findings, stating that they reinforce Vabysmo's potential to become the standard of care for DME, a condition affecting 29 million people globally. He was particularly impressed that 90% of patients exhibited no signs of DME after four years of treatment.

The RHONE-X study is notable for its extensive dataset, making it the largest long-term extension study in DME. Dr. Arshad M. Khanani, a study investigator and clinical professor at the University of Nevada, Reno, shared his positive clinical experience with Vabysmo, which aligns with the study's long-term safety and efficacy results.

During the RHONE-X study, participants were treated with Vabysmo on a personalized schedule, with treatment intervals adjusted based on retinal fluid levels and visual acuity. Nearly 80% of participants managed to extend their treatment intervals to every three or four months by the end of the study. The results showed sustained vision improvements and retinal fluid reduction, consistent with initial Phase III studies (YOSEMITE and RHINE). Furthermore, over 90% of participants achieved an absence of DME, defined by a central subfield thickness (CST) of less than 325 microns.

Vabysmo is currently approved in nearly 100 countries for DME and neovascular age-related macular degeneration (AMD). It is also authorized for treating macular edema following retinal vein occlusion in several countries, including the United States and Japan. Since its initial U.S. approval in 2022, over four million doses of Vabysmo have been distributed globally.

Genentech is dedicated to ensuring that patients have access to their prescribed medications and offers comprehensive services to minimize barriers to access and reimbursement. For those who qualify, Genentech provides patient assistance programs through Genentech Access Solutions.

RHONE-X is a multicenter, two-year extension study designed to evaluate the long-term safety and tolerability of Vabysmo in 1,474 patients with DME who completed either the YOSEMITE or RHINE Phase III studies. The primary objectives included assessing ocular and non-ocular adverse events and the presence of anti-drug antibodies. The study also explored the long-term efficacy of Vabysmo.

Diabetic macular edema (DME) is a severe retinal condition that can lead to vision loss and a decreased quality of life if left untreated. It affects approximately 750,000 people in the United States. As the prevalence of diabetes rises, the number of people with DME is also expected to grow.

Genentech's robust Phase III clinical development program for Vabysmo includes several extension studies to evaluate its long-term safety and efficacy. These studies aim to address unmet needs in retinal conditions and expand the understanding of Vabysmo's role in treating these diseases.

Vabysmo, the first bispecific antibody approved for the eye, targets and inhibits two signaling pathways associated with various vision-threatening retinal conditions. By blocking pathways involving angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), Vabysmo is designed to stabilize blood vessels and reduce inflammation, potentially preventing vision loss.

In summary, the RHONE-X study's four-year data highlights Vabysmo's long-term safety, efficacy, and potential to become a standard treatment for DME, offering hope to millions affected by this condition worldwide.