Genentech has announced positive top line results from its Phase III Archway study, evaluating Port Delivery System (PDS) with Lucentis (ranibizumab) in people living with wet (neovascular)AMD.
PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of Lucentis over a period of months. The Archway trial demonstrated that patients who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly injections. The implant was generally well-tolerated with a favorable benefit-risk profile.
“For people around the world receiving frequent eye injections for [wet] AMD, this continuous delivery system could greatly reduce their treatment burden,” said Levi Garraway, M.D., Ph.D., Genentech’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 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 and European Medicines Agency, for consideration of regulatory approval for the treatment of wet AMD.
SOURCE: Press Release