Benzinga | Jul 29, 2021 08:04AM EDT

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

* The FDA has accepted Roche Holding AG's (OTC: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 EuropeanMedicines 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.