Genentech, a member of the Roche Group (RHHBY), announced Thursday that the U.S. Food and Drug Administration has accepted the company's Biologics License Application or BLA, under Priority Review, for Port Delivery System with ranibizumab to treat wet, or neovascular, age-related macular degeneration.
The FDA is expected to make a decision on approval by October 23.
Wet age-related macular degeneration or AMD is a cause of blindness for people aged 60 and over and impacts around 1.1 million people in the United States.
If approved, Port Delivery System with ranibizumab or PDS would be a first-of-its-kind therapeutic approach, offering people living with wet AMD an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the current standard of care.
PDS is a permanent refillable eye implant, around the size of a grain of rice, designed to continuously deliver a customized formulation of ranibizumab over a period of months, potentially reducing the treatment burden associated with frequent eye injections.
If approved, PDS would provide up to six months of uninterrupted therapy that could potentially improve vision outcomes compared to what is currently achieved in the clinic.
The BLA submission is based on positive results from the Phase III Archway study primary analysis. The trial showed that more than 98% of those wet AMD patients being treated with PDS were able to go six months without needing additional treatment prior to the refill exchange.
The PDS Marketing Authorization Application has also been validated by the European Medicines Agency and is currently under review.
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