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.
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