Roche announced new, four-year data from the RHONE-X extension study today. The study met all primary endpoints, demonstrating that Vabysmo® (faricimab) was well tolerated in people with diabetic macular edema (DME) who received treatment for up to four years. The long-term study results showed that Vabysmo continued to preserve vision, dry retinal fluid that can impair sight, and extend time between treatments in people with DME. These findings were presented 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 the standard of care for 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 that 9 out of 10 patients showed no sign of DME after four years of treatment with Vabysmo, an incredible long-term outcome for those 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 approved indications, including DME, 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 personalized treat-and-extend regimen, where the time between treatments could be increased based on retinal fluid levels and visual acuity. Results showed that nearly 80% of participants extended their treatment intervals to every three or four months by the end of four years. Additionally, patients maintained vision improvements and sustained retinal drying achieved during the initial Phase III studies (YOSEMITE and RHINE). More than 90% of patients achieved absence of DME, defined as central subfield thickness (CST) less than 325 microns, a measure indicating reduced retinal swelling.
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 treating macular edema following retinal vein occlusion. Over four million doses of Vabysmo have been distributed worldwide since its initial US approval in 2022.
About RHONE-X:
RHONE-X is a multicenter two-year extension study designed to evaluate the long-term safety and tolerability of Vabysmo® (faricimab) in 1,474 patients with DME who completed one of the Phase III studies, YOSEMITE (NCT03622580) or RHINE (NCT03622593). Patients in RHONE-X were treated with Vabysmo according to a personalized treatment interval. The study aimed to evaluate long-term safety and tolerability, including ocular and non-ocular adverse events, and presence of anti-drug antibodies, with an exploratory objective to assess long-term efficacy.
About Diabetic Macular Edema:
Affecting around 29 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition that can lead to blindness and decreased quality of life if left untreated. DME occurs when damaged blood vessels leak and cause swelling in the macula, the central area of the retina responsible for sharp vision needed for reading and driving. The prevalence of DME is expected to grow as diabetes rates increase.
About the Vabysmo® (faricimab) Clinical Development Program:
Roche has a robust Phase III clinical development program for Vabysmo, including the AVONELLE-X (NCT04777201) extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300), evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD). Several Phase IV studies have also been initiated, including ELEVATUM (NCT05224102) for underrepresented DME patient populations, the SALWEEN study for an nAMD subpopulation prevalent in Asia, and the POYANG (NCT06176352) study for treatment-naive patients with choroidal neovascularization secondary to pathologic myopia. The VOYAGER (NCT05476926) study is a global real-world data collection platform, with several other independent studies supported to further understand retinal conditions with high unmet needs.
About Vabysmo® (faricimab):
Vabysmo is the first bispecific antibody approved for the eye, targeting and inhibiting two signaling pathways linked to vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). By blocking these pathways, Vabysmo stabilizes blood vessels and reduces inflammation. It is approved in nearly 100 countries, including the US, Japan, the UK, and the EU, for neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and for macular edema following retinal vein occlusion in several countries.
About Roche in Ophthalmology:
Roche is dedicated to saving eyesight from leading causes of vision loss through pioneering therapies. With a focus on scientific discovery, personalized healthcare, molecular engineering, biomarkers, and continuous drug delivery, Roche aims to design the right therapies for the right patients. Roche has the broadest retina pipeline in ophthalmology, including gene therapies and treatments for multiple vision-threatening conditions such as diabetic eye diseases, geographic atrophy, and autoimmune conditions like thyroid eye disease and uveitic macular edema. Roche has brought breakthrough ophthalmic treatments to people living with vision loss, including Susvimo® for neovascular or ‘wet’ age-related macular degeneration, and Vabysmo® for various retinal conditions. Lucentis® was the first treatment approved to improve vision in people with certain retinal conditions.
