FDA Accepts Application For Genentech's Eye Disease Drug Faricimab

Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has accepted the company's Biologics License Application or BLA, under Priority Review, for faricimab for the treatment of wet, or neovascular, age-related macular degeneration or AMD and diabetic macular edema or DME.

The FDA has also accepted the company's submission for diabetic retinopathy.

The company noted that across four Phase III studies, approximately half of patients receiving faricimab could extend treatment time to every four months. It is the first time this level of durability has been achieved in Phase III wet AMD and DME studies.

If approved, faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care.

Wet AMD and DME are two leading causes of vision loss among adults in the United States.

The European Medicines Agency has also validated the faricimab Marketing Authorization Application for the treatment of wet AMD and DME.

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