Genentech and Roche initiated a phase 3 clinical trial to investigate the Port Delivery System with ranibizumab to treat patients with diabetic macular edema, according to a press release.
The Port Delivery System (PDS) is a refillable eye implant designed to continuously release a customized formulation of ranibizumab over a period of months.
“We are excited that patient enrollment in Pagoda has begun. This is the first clinical trial to investigate the PDS in DME, a serious retinal condition that affects nearly 750,000 people in the U.S. and is the leading cause of blindness among working-aged adults,” Anne Fung, MD, global development lead of the PDS at Genentech and a retina specialist in San Francisco, said in the release. “While we have effective therapies for DME, the treatment burden on patients can be high, with as often as monthly injections. With the PDS, our hope is that these patients may be able to go up to 6 months between treatments.”
The PDS is intended to reduce the patient burden of frequent injections by allowing patients to go several months before needing to refill the implant.
The multicenter, randomized, active-comparator, noninferiority study will evaluate the safety, efficacy and pharmacokinetics of the PDS. Approximately 550 patients with DME will be randomly assigned to receive either PDS 100 mg/mL refilled at 6-month intervals or monthly intravitreal injections of ranibizumab 0.5 mg.
The PDS is also being evaluated in patients with wet age-related macular degeneration in the phase 3 Archway trial.