Roche announced positive topline results from the phase III Archway study, evaluating Port Delivery System with ranibizumab (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.
Neovascular AMD is a leading cause of blindness in people aged 60 and older globally. The current standard of care for nAMD requires patients to visit their ophthalmologist as often as monthly for eye injections of anti-vascular endothelial growth factor (VEGF) therapy to help maintain vision gains and/or prevent vision loss. This high treatment burden with anti-VEGF therapy can lead to under-treatment of nAMD and, potentially, less than optimal vision outcomes.
"For people around the world receiving frequent eye injections for neovascular AMD, this continuous delivery system could greatly reduce their treatment burden,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to presenting detailed Archway results at future medical meetings and discussing these data with regulatory authorities, with the aim of bringing this new treatment option to patients as soon as possible.”
In addition to Archway, the Portal study is investigating the long-term safety and tolerability of PDS for the treatment of nAMD. Furthermore, PDS is also being studied in the Pagoda trial for the treatment of diabetic macular edema (DME), a vision-threatening complication of diabetes.
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 (FDA) and European Medicines Agency (EMA), for consideration of regulatory approval for the treatment of nAMD.
