Roche's Faricimab US Application For Ocular Diseases Under Priority Review

  • The FDA has accepted Roche Holding AG's RHHBY Biologics License Application seeking approval for faricimab in neovascular of wet age-related macular degeneration (nAMD) and diabetic macular edema (DME).
  • The application is under priority review. The FDA has also accepted the company's submission for diabetic retinopathy.
  • Faricimab will be the first and only bispecific antibody designed for the eye if approved. 
  • It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which drive many retinal conditions that can cause vision loss.
  • The European Medicines Agency has also validated the faricimab's application for nAMD and DME.
  • Price Action: RHHBY shares closed at $47.64 on Wednesday.
  • Related content: Benzinga's Full FDA Calendar.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsWet AMD
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