Roche announces that the CHMP of the European Medicines Agency has adopted a positive opinion for the extension of Vabysmo's marketing authorization to the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO).

This positive recommendation is based on two Phase 3 studies which, in addition to robust retinal drying with Vabysmo, showed early and durable improvements in vision, which are not inferior to aflibercept.

A final decision is expected from the European Commission in the near future. If approved, Vabysmo would be the first and only bispecific antibody treatment available for nearly a million people with RVO in the EU.

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