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.