Genentech/Roche Complete Enrollment in Archway Phase 3 Study of the Port Delivery System with Ranibizumab in Wet AMD

Genentech and Roche have completed patient enrollment in the phase 3 Archway (NCT03677934) clinical trial investigating the Port Delivery System with ranibizumab (PDS) in people with wet age-related macular degeneration (AMD). The PDS is a first-of-its-kind refillable eye implant designed to continuously release a customized formulation of ranibizumab over a period of months.

Archway, the first phase 3 trial with a device used for the continuous delivery of an anti-VEGF therapy, is a multicenter, randomized, visual assessor-masked, active-comparator controlled trial that will evaluate the PDS for the treatment of wet AMD using fixed interval dosing. In the trial, patients are randomized into one of two arms: Arm A receives the PDS implant with refills at fixed 24-week intervals of the special formulation of 100 mg/mL ranibizumab, and Arm B receives monthly intravitreal injections of 0.5 mg ranibizumab. The primary endpoint of this study is noninferiority in the change from baseline in best-corrected visual acuity (BCVA) averaged over weeks 36 and 40. The PDS allows continuous delivery of ranibizumab and thus is intended to reduce the burden of frequent eye injections by allowing people with wet AMD to go several months before needing a refill of the implant, and to address under-treatment that could lead to vision loss.

“We are excited to announce that we have completed enrollment of the Archway trial for the PDS in wet AMD, for which we thank both the patients’, and our investigators’, commitment. Wet AMD is a serious, vision-threatening condition and while effective treatments exist, they require as often as monthly injections which can be a burden to patients, their caregivers and the healthcare system; a burden which the PDS aims to address,” Christopher Brittain, Global Head of Genentech’s Ophthalmology Clinical Development program, said in a company statement. “We are encouraged by the positive results seen in the phase 2 Ladder study and eagerly anticipate the results of Archway.”

The Archway trial was initiated based on the results of the phase 2 Ladder study, announced last year, which showed that 50 percent of patients in the PDS 100 mg/mL group were able to go 15 months or longer before needing their first refill. Furthermore, 80 percent of patients in the 100 mg/mL arm were able to go six months or longer between the implant of the device and the first required refill.