FDA accepts application for Port Delivery System to treat wet AMD
The FDA has accepted a biologics license application for Genentech’s Port Delivery System with ranibizumab for the treatment of wet age-related macular degeneration, according to a press release.
The Port Delivery System (PDS), a permanent refillable eye implant, is designed to continuously deliver ranibizumab over several months. The application is supported by data from the phase 3 Archway study, which found that 98% of patients receiving medication through the system were able to go 6 months without additional treatment before refill, the release said. Vision outcomes were similar to patients who receive monthly ranibizumab injections.
Genentech has several phase 3 trials for the PDS underway, including Portal, examining long-term safety and efficacy of the system in wet AMD; Pagoda, which is evaluating the system in patients with diabetic macular edema; and Pavilion, which is studying the system in patients with diabetic retinopathy without DME, the release said.
The FDA decision on approval is expected by Oct. 23.
In addition, the European Medicines Agency validated the device’s marketing authorization application, and it is now under review, the release said.
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