Port Delivery System with Ranibizumab Demonstrates Positive Phase III Results in nAMD

Compiled by Fan Dongdong

Recently, Genentech, a member of the Roche Group, announced positive results from the Phase 3 Archway trial, which evaluated the efficacy of ranibizumab PDS (ranibizumab port delivery system) for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

The Port Delivery System (PDS) is a small, refillable intraocular implant, approximately the size of a grain of rice, designed to eliminate the need for patients with neovascular age-related macular degeneration (nAMD) to make frequent visits to their ophthalmologist for supplemental dosing over several months. Following implantation, patients receive continuous treatment with a customized formulation of ranibizumab for several months.

Archway (NCT03677934) is a randomized, multicenter, open-label Phase 3 clinical study evaluating the efficacy and safety of ranibizumab administered via the Port Delivery System (PDS) with fixed-interval refills (every 6 months) versus monthly intravitreal injections of ranibizumab. The study enrolled a total of 418 patients with neovascular age-related macular degeneration (nAMD). The primary endpoint was the mean change from baseline in best-corrected visual acuity (BCVA) scores at Week 36 and Week 40.

The results showed that the Archway trial met its primary endpoint, with visual acuity outcomes in patients receiving ranibizumab PDS being comparable to those in patients receiving monthly intravitreal injections of ranibizumab. In the Archway trial, the PDS implant demonstrated favorable tolerability and a favorable risk/benefit profile.

Wet age-related macular degeneration is the leading cause of blindness among individuals aged 60 years and older in the United States. The current standard of care for wet age-related macular degeneration requires patients to receive intravitreal anti-vascular endothelial growth factor (VEGF) injections from an ophthalmologist at least once a month, which is the established approach to preserve and/or prevent further vision loss. The high treatment burden associated with anti-VEGF therapy may lead to undertreatment. Furthermore, frequent intravitreal injections increase the risk of complications related to intraocular procedures, such as cataracts and endophthalmitis.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, stated, “For patients with wet age-related macular degeneration who frequently receive intravitreal injections, the Port Delivery System (PDS), a continuous drug delivery system, can significantly reduce the treatment burden.”

The full results of the Archway trial will be presented at an upcoming medical conference and submitted to global health regulatory authorities, including the U.S. FDA and the European EMA, to advance regulatory approval of the device for the treatment of wet age-related macular degeneration.

In addition to Archway, another study named Portal evaluated the long-term safety and tolerability of ranibizumab PDS for the treatment of wet age-related macular degeneration, as well as its efficacy in treating diabetic macular edema (DME).

Reference Source:

Port Delivery System With Ranibizumab Shows Positive Phase III Results in Neovascular Age-Related Macular Degeneration