Roche announced new clinical and real-world data for its drug Vabysmo, showing promising results for individuals suffering from two leading causes of vision loss. Late-breaking, post-hoc data reveals that Vabysmo leads to less fibrosis, which can negatively impact vision, compared to aflibercept in people with diabetic macular edema (DME).
Moreover, real-world data reaffirm that Vabysmo, when used as a first-line treatment, leads to improved outcomes and extends treatment intervals rapidly during the first four months for individuals with neovascular or 'wet' age-related macular degeneration (nAMD) and DME.
Roche announced it will present data from its ophthalmology portfolio in 25 abstracts at the upcoming 2023 American Society of Retina Specialists (ASRS) Annual Meeting in Seattle, United States. With new data, Roche aims to strengthen further the clinical and real-world evidence supporting Vabysmo (faricimab), the first and only bispecific antibody for the eye, as a treatment for neovascular AMD and diabetic macular edema (DME).
With over 70 countries approving Vabysmo for nAMD and DME treatment and public reimbursement in more than 20 markets, the drug has already been distributed globally, with over one million doses administered. It's important to note that neovascular AMD and DME significantly contribute to vision loss worldwide, affecting more than 40 million people.
Roche has scheduled to present late-breaking data on Vabysmo's effect on epiretinal membrane (ERM) formation in DME, compared to aflibercept, at the meeting. The data from the two-year post-hoc analysis of the YOSEMITE and RHINE phase III studies indicate that Vabysmo leads to less retinal fibrosis than aflibercept. ERMs are fibrotic tissues on the retina's surface that can hurt eye anatomy and compromise vision.
The conference will also feature data demonstrating Vabysmo's positive anatomical outcomes, including reduced blood vessel leakage in the macula and better and faster retinal fluid control. These outcomes are critical in preventing sight loss caused by fluid build-up and swelling in the back of the eye.
Additionally, the data will further support Vabysmo's efficacy even with increased dosing intervals compared to aflibercept, showing no compromise in treatment outcomes. Roche's ongoing real-world studies for Vabysmo encompass more than 8,500 participants across nearly 30 countries. The FARETINA studies in nAMD and DME will provide insight into extended dosing intervals, their impact on vision, and insights into Vabysmo's performance as a first-line treatment.