Vabysmo Showed Extended Durability, Continued Efficacy and a Consistent Safety Profile in Long-Term DME Study

At the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden, Genentech announced new, 4-year data from the RHONE-X extension study. The study met all primary endpoints, showing that Vabysmo (faricimab-svoa) was well tolerated in people with diabetic macular edema (DME) who received treatment for up to 4 years. Exploratory results from the long-term study showed that Vabysmo continued to preserve vision, dry retinal fluid that can impair sight, and allow extended time between treatments in people with DME. 

“These four-year data build on our pivotal studies and reinforce Vabysmo’s potential to become standard of care treatment for diabetic macular edema (DME), which affects 29 million people worldwide,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, said in a company news release. “We are especially pleased to see that 9 out of 10 patients showed no sign of DME after 4 years of treatment with Vabysmo, which is an incredible long-term outcome for people living with this condition.”

The data were presented by Arshad M. Khanani, MD, a study investigator and director of clinical research at Sierra Eye Associates and clinical professor at the University of Nevada, Reno.

The RHONE-X study is the largest long-term extension dataset in DME, a leading cause of vision loss in people with diabetes.

During RHONE-X, all participants were treated with Vabysmo on a personalized treat-and-extend regimen, where the time between Vabysmo treatments could be increased based on retinal fluid levels and visual acuity. Results of the exploratory analysis showed that at the end of 4 years, nearly 80% of participants treated with Vabysmo had extended their treatment intervals to every 3 or 4 months. Additionally, people treated with Vabysmo maintained the vision improvements and sustained the drying of retinal fluid they achieved during the initial phase 3 studies (YOSEMITE and RHINE). In a prespecified exploratory endpoint, more than 90% of people treated with Vabysmo achieved absence of DME, defined as central subfield thickness (CST) less than 325 microns. 

To date, Vabysmo is approved in nearly 100 countries for DME and wet age-related macular degeneration (AMD). It is also approved in several countries, including the United States and Japan, for the treatment of macular edema following retinal vein occlusion.