Roche’s Vabysmo Proves Durable and Effective in Long-Term DME Study

Roche has unveiled four-year data from the RHONE-X extension study, demonstrating the long-term efficacy and safety of Vabysmo® (faricimab) in treating diabetic macular edema (DME). The study, which is the largest of its kind, confirmed that Vabysmo was well-tolerated and effective in preserving vision and reducing retinal fluid over an extended period. These findings were presented at The American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.

The RHONE-X study met all its primary endpoints, indicating that the safety profile of Vabysmo remained consistent with previous findings. According to Roche’s Chief Medical Officer, Dr. Levi Garraway, the study results support Vabysmo’s potential to become the standard treatment for DME, a condition affecting approximately 29 million people globally. Notably, more than 90% of patients exhibited no signs of DME after four years of treatment, an outcome described as remarkable for those living with the condition.

Exploratory results revealed that nearly 80% of participants could extend their treatment intervals to three to four months, maintaining both visual acuity and reduced retinal fluid. This regimen was personalized based on retinal fluid levels and visual acuity, aligning with the treat-and-extend approach used during the study. These long-term results build on the data from the initial Phase III studies, YOSEMITE and RHINE, where participants had already shown significant improvements.

Vabysmo’s approval spans nearly 100 countries for treating both DME and neovascular or ‘wet’ age-related macular degeneration (nAMD). It is also authorized in several regions, including the United States and Japan, for treating macular edema following retinal vein occlusion. Since its initial US approval in 2022, over four million doses of Vabysmo have been distributed worldwide.

The RHONE-X study involved 1,474 patients who had completed either the YOSEMITE or RHINE Phase III studies. All participants in RHONE-X received Vabysmo following personalized treatment intervals. The primary objectives were to assess the long-term safety and tolerability of Vabysmo, monitoring both ocular and non-ocular adverse events as well as the presence of anti-drug antibodies. Additionally, the study aimed to explore the long-term efficacy of the drug.

Diabetic macular edema is a serious retinal condition linked to diabetes, leading to vision loss and reduced quality of life if untreated. The condition arises when damaged blood vessels leak fluid into the macula, causing swelling. As diabetes prevalence increases, the number of individuals affected by DME is expected to rise.

Roche has an extensive Phase III clinical development program for Vabysmo, including studies like AVONELLE-X, an extension of the TENAYA and LUCERNE trials, focusing on long-term safety and tolerability in nAMD. In addition, several Phase IV studies are underway, such as ELEVATUM, which explores Vabysmo’s effects in underrepresented populations with DME, and SALWEEN, focusing on a specific subgroup of nAMD prevalent in Asia. Another study, POYANG, evaluates Vabysmo in treatment-naive adults with choroidal neovascularization due to pathologic myopia.

Roche also supports the VOYAGER study, a global real-world data collection initiative, and other independent studies aimed at understanding retinal conditions with significant unmet needs better.

Vabysmo is the first bispecific antibody approved for ophthalmic use, targeting two pathways associated with retinal diseases—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). By inhibiting these pathways, Vabysmo helps stabilize blood vessels, preventing leakage and inflammation, thereby preserving vision. The drug has received regulatory approvals across various countries, including the US, Japan, the UK, and the European Union.

Through its innovative approach, Roche aims to develop groundbreaking therapies for vision-threatening conditions, leveraging advancements in drug delivery, molecular engineering, and personalized healthcare. The company continues to lead in ophthalmology with a broad pipeline of treatments, including gene therapies and solutions for a range of retinal diseases.