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EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.
Roche announced on Sept. 19, 2022 that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). These conditions are two of the leading causes of vision loss worldwide, affecting more than 40 million people, according to a company press release.
Faricimab is currently the only injectable eye medicine approved in Europe. The treatment will begin at intervals of up to four months for people with nAMD and DME, with the potential to require fewer eye injections over time. The treatment is a bispecific antibody designed to target and inhibit two disease pathways to restore vascular stability.
“Many people with nAMD and DME struggle to keep up with the monthly eye injections and physician visits, often associated with current standards of care, and unfortunately their vision may suffer as a result of undertreatment,” said Ramin Tadayoni, head of the ophthalmology department, Lariboisière, Saint-Louis and Rothschild Hospitals, Paris, France, and European Society of Retina Specialists (EURETINA) president elect, in the release. “For people in Europe living with these conditions, today’s approval offers the first new mechanism of action in over a decade; one which could improve and protect their vision with fewer injections over time.”