Europe Approves First Bispecific Antibody From Roche For Two Eye Disorders

The European Commission approved Roche Holding AG's RHHBY Vabysmo (faricimab) for neovascular or 'wet' age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).
These retinal conditions affect more than 40 million people globally.
Vabysmo is the only injectable eye medicine approved in Europe, with phase 3 studies supporting treatment at intervals of up to four months for people living with nAMD and DME.
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The approval is based on four phase 3 studies involving 3,220 patients. The studies showed that people treated with Vabysmo, up to every four months, achieved similar outcomes compared to those receiving treatment every two months with aflibercept.
The totality of data across all four studies at two years showed that more than 60% of people treated with Vabysmo could extend treatment to every four months while improving and maintaining vision.
Additionally, for up to two years, people with nAMD and DME treated with Vabysmo received 33% (10 vs. 15) and 21% (11 vs. 14) fewer median number of injections than aflibercept, respectively.
Vabysmo is now approved in the European Union and nine other countries. Globally, more than 100,000 Vabysmo doses have been distributed.
Price Action: RHHBY shares traded lower by 1.70% at $41.63 on the last check Monday.