The monoclonal antibody faricimab could extend the treatment interval for macular edema due to branch and central retinal vein occlusion by up to four months, two conditions that currently require monthly or bimonthly therapies. This is what was announced today by Roche in relation to the results of the two phase 3 studies, Balaton and Comino, which will be presented on February 3 during the Angiogenesis, Exudation, and Degeneration 2024 conference, organized by the Bascom Palmer Eye Institute in Florida, in the United States .
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The pathology
Retinal vein occlusion (RVO) is a disorder that affects approximately 28 million adults worldwide. It usually occurs after the age of 60 and is the second most common cause of vision loss related to retinal vascular disease. It often begins with a sudden and painless loss of vision, and is caused by obstruction of the vein that limits the normal flow of blood in the retina, causing ischemia, bleeding, leakage of fluid and swelling of the retina, the so-called macular edema.
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There are two main types of RVO: branch retinal vein occlusion (BRVO), which affects more than 23 million people globally and occurs when one of the four smaller “branches” of the main central retinal vein becomes blocked; and central retinal vein occlusion (CRVO), which is less common – affecting around four million people worldwide – and occurs when the central retinal vein of the eye becomes blocked. In both cases, standard therapy currently involves intravitreal injections of anti-vascular endothelial growth factor drugs, usually repeated every month or every two months.
The new studies
Faricimab is the first and to date only bispecific antibody approved for ocular use, designed to target and inhibit two metabolic pathways connected to retinal diseases: angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) . It is currently approved in more than 90 countries for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). Use in patients with RVO was authorized in October 2023 by the US Food and Drug Administration, and now new data from the Balaton and Comino studies will be presented to other regulatory agencies, including the European EMA.
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In fact, the company makes it known that in both studies faricimab proved to be effective both in patients with BRVO and in patients with CRVO in improving the corrected visual acuity score (which evaluates distance vision) and in reducing the extent of edema at the back of the eye due to retinal fluid, measured by central retinal thickness. The results, he reports, also show that 60% of patients with BRVO and 48% of those with CRVO can extend treatment intervals up to four months, with improvements in vision and reduction in retinal fluid achieved in the first 24 weeks they were maintained for up to 72 weeks.
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“Improvements in vision and retinal fluid absorption maintained up to 72 weeks confirm faricimab as an effective treatment for retinal vein occlusion,” he underlined. Ramin Tadayonihead of the Department of Ophthalmology at Cité University in Paris, who will present the data at the Angiogenesis conference – More therapeutic options are needed to treat people with this condition, and these data show that faricimab can potentially improve outcomes by reducing the number of necessary visits”.