Vabysmo (faricimab) showed extended durability, continued efficacy and a consistent safety profile in long-term diabetic macular edema study – Roche

Roche announced four-year data from the RHONE-X extension study. The study met all primary endpoints, showing that Vabysmo (faricimab) was well tolerated in people with diabetic macular edema (DME) who received treatment for up to four 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 data were presented in a late-breaking oral presentation at The American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.

“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,” 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.”

The RHONE-X study is the largest long-term extension dataset in DME, a leading cause of vision loss in people 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 study investigator Arshad M. Khanani, M.D., Director of Clinical Research at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno, who presented the data at the ASRS.

During RHONE-X, all participants were treated with Vabysmo on a personalised 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 four years, nearly 80% of participants treated with Vabysmo had extended their treatment intervals to every three or four months. Additionally, people treated with Vabysmo maintained the vision improvements and sustained the drying of retinal fluid they achieved during the initial Phase III studies (YOSEMITE and RHINE). In a pre-specified exploratory endpoint, more than 90% of people treated with Vabysmo achieved absence of DME, defined as central subfield thickness (CST) less than 325 microns. CST is a measure of swelling from fluid in the back of the eye caused by unstable, leaky blood vessels; reducing CST indicates retinal drying.

To date, Vabysmo is approved in nearly 100 countries for DME and neovascular or ‘wet’ age-related macular degeneration (nAMD). It is also approved in several countries, including the United States and Japan, for the treatment of macular edema following retinal vein occlusion. More than four million doses of Vabysmo have been distributed worldwide since its initial US approval in 2022.

About RHONE-X1 : RHONE-X is a multicentre two-year extension study designed to evaluate the long-term safety and tolerability of Vabysmo (faricimab) in 1,474 patients with diabetic macular edema who completed one of the two Phase III studies, YOSEMITE (NCT03622580) or RHINE (NCT03622593). Patients in YOSEMITE and RHINE were treated with either Vabysmo or 2 mg aflibercept. Patients in RHONE-X were all treated with Vabysmo according to a personalised treatment interval. The primary objectives were to evaluate the long-term safety and tolerability of Vabysmo, including ocular adverse events (AEs), non-ocular AEs and presence of anti-drug antibodies. The study also had an exploratory objective to assess the long-term efficacy of Vabysmo.