Phase III Archway study of Lucentis Port Delivery System meets primary endpoint in age-related macular degeneration.- Genentech/Roche

Genentech/Roche announced positive topline results from the Phase III Archway study, evaluating Lucentis Port Delivery System (ranibizumab or PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months. The Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections. In Archway, PDS was generally well-tolerated with a favorable benefit-risk profile.

Archway ( NCT03677934 ) is a randomized, multicenter, open-label Phase III study evaluating the efficacy and safety of Port Delivery System with ranibizumab (PDS), refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 418 people living with neovascular age-related macular degeneration (nAMD). The primary endpoint of the study is the change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at the average of week 36 and week 40.

Full results from the Archway study will be presented at an upcoming medical meeting and submitted to health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency, for consideration of regulatory approval for the treatment of nAMD.