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Biotech Stocks Facing FDA Decision In October 2021

Roche
Roche

Roche Holding AG’s (RHHBY.OB) Port Delivery System with Ranibizumab for the treatment of neovascular or “wet” age-related macular degeneration is under priority review by the FDA, with a decision anticipated on October 23, 2021.

Neovascular or “wet” age-related macular degeneration (nAMD) is a leading cause of blindness for people aged 60 and over and impacts approximately 20 million people worldwide.

Currently, the standard of care for wet AMD is monthly injections of anti-VEGF drugs like Bevacizumab (Avastin) or Rranibizumab (Lucentis).

The Port Delivery System (PDS) is a permanent refillable eye implant, approximately the size of a grain of rice, designed to continuously deliver a customised formulation of ranibizumab over a period of months, potentially reducing the treatment burden associated with frequent eye injections, according to Roche.

If approved, PDS would be the first and only eye implant with continuous drug delivery that offers people living with nAMD an alternative to frequent eye injections.

RHHBY.OB closed Wednesday’s trading at $45.18, up 0.83%.