Roche announced today that its drug Vabysmo (faricimab) continues to show promising results in treating diabetic macular edema (DME), a condition that can lead to vision loss. The RHONE-X extension study's four-year data revealed that Vabysmo is effective and safe for long-term use in people with DME.

In the study, over 90% of patients showed no signs of DME after four years. Additionally, nearly 80% of the participants were able to extend their treatment intervals to three or four months. This means they needed fewer injections over time while maintaining their vision improvements and reducing retinal fluid, which can impair sight.

“These four-year data build on our pivotal studies and reinforce Vabysmo’s potential to become the standard of care treatment for diabetic macular edema (DME), which affects 29 million people worldwide,” said Levi Garraway, M.D., Ph.D., Roche’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.”

Dr. Arshad M. Khanani, Director of Clinical Research at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno, who presented the data at the ASRS, added, “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.”

The study met all its primary goals, showing that Vabysmo is well tolerated. The safety data matched the known safety profile of the drug, ensuring that it does not cause unexpected side effects.

DME is a condition in which damaged blood vessels leak fluid into the macula, the central part of the retina responsible for sharp vision. This fluid buildup causes swelling and can lead to vision loss if untreated. Vabysmo works by drying the retinal fluid and maintaining vision improvements over time.

Roche's RHONE-X study is the largest long-term study of its kind for DME, involving 1,474 patients. This study follows two earlier Phase III studies, YOSEMITE and RHINE, and confirms the long-term benefits of Vabysmo. Roche aims to make Vabysmo a standard treatment for DME, offering hope to millions of people worldwide.

Nearly 100 countries have approved Vabysmo to treat DME and neovascular or 'wet' age-related macular degeneration (nAMD). Since its initial approval in the US in 2022, the world has distributed more than four million doses.

Roche continues to study Vabysmo in various patient populations and conditions to further understand its benefits and ensure it meets the needs of those with retinal conditions.