FDA accepts application for port delivery system with ranibizumab (PDS) for treatment of wet age-related macular degeneration (AMD)

Application is for a permanent refillable eye implant, approximately 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.

SPS commentary:

Phase III Archway study showed that amongst patients being treated with PDS, more than 98% were able to go six months without needing additional treatment prior to the refill exchange. In addition, they achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections. The European Medicines Agency has also validated the PDS Marketing Authorization Application in wet AMD

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