Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), unveiled new four-year findings from the RHONE-X extension study today. The study successfully met all primary endpoints, underscoring the well-tolerated nature of Vabysmo® (faricimab-svoa) in individuals with diabetic macular edema (DME) over an extended treatment period. Presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden, these results demonstrate Vabysmo’s sustained ability to preserve vision, dry retinal fluid, and extend treatment intervals for DME patients.
“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,” remarked Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “We are especially pleased to see that 9 out of 10 patients showed no sign of DME after four years of treatment with Vabysmo, which is an incredible long-term outcome for people living with this condition.”
The RHONE-X study represents the largest long-term extension dataset in DME, a leading cause of vision impairment among individuals with diabetes.
“I have been using Vabysmo as a first-line treatment for all the approved indications, including diabetic macular edema, and the positive long-term safety and efficacy results from the RHONE-X study are consistent with my clinical experience for over two years,” said Dr. Arshad M. Khanani, study investigator and director of clinical research at Sierra Eye Associates, as well as clinical professor at the University of Nevada, Reno, who presented the data at ASRS.
Throughout RHONE-X, participants received personalized treatment with Vabysmo on a treat-and-extend basis, enabling adjustments in treatment intervals based on retinal fluid levels and visual acuity. Exploratory analyses revealed that nearly 80% of participants extended their treatment intervals to every three or four months by the study’s conclusion at four years. Furthermore, those treated with Vabysmo maintained vision improvements and sustained retinal fluid reduction achieved during the initial Phase III studies (YOSEMITE and RHINE). A pre-specified exploratory endpoint also indicated that over 90% of Vabysmo-treated individuals achieved absence of DME, defined by central subfield thickness (CST) less than 325 microns—a crucial indicator of reduced swelling due to fluid accumulation in the eye.
As of now, Vabysmo is approved in nearly 100 countries for DME and wet age-related macular degeneration (AMD), and in select countries for macular edema post-retinal vein occlusion. Since its initial approval in the U.S. in 2022, more than four million doses of Vabysmo have been distributed globally.
Genentech remains dedicated to facilitating patient access to prescribed medications, offering comprehensive services to minimize access and reimbursement barriers for individuals using Vabysmo.
