Roche’s Ranibizumab Port Delivery System Achieves Primary Endpoint in Phase III ARCHWAY Trial, Enabling Over 98% of nAMD Patients to Maintain Six-Month Dosing Interval

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Recently, Roche announced the detailed results of the Phase III ARCHWAY trial. This was a randomized, multicenter, open-label study conducted in 418 patients with neovascular (wet) age-related macular degeneration (nAMD). These patients had received at least three anti-VEGF injections within six months prior to study screening and were confirmed to be responsive to anti-VEGF therapy. The study compared treatment with the novel intraocular drug delivery system ranibizumab PDS (ranibizumab port delivery system), administered via fixed-interval refills every six months, versus monthly intravitreal injections of ranibizumab.

nAMD is the leading cause of blindness in individuals aged 60 and older. Ranibizumab is currently the standard of care for treating nAMD; however, patients require regular (monthly) intravitreal injections at a hospital. The Port Delivery System (PDS) is a permanent, refillable intraocular implant approximately the size of a grain of rice. It is designed to continuously release a customized formulation of ranibizumab into the eye over time, thereby reducing the annual frequency of injection treatments for patients with nAMD.

Ranibizumab is replenished into the PDS via an injection needle.

Data show that the Archway study met its primary endpoint: 98.4% of patients with the Port Delivery System (PDS) were able to receive refills every six months without additional treatment, and visual acuity outcomes were consistent with those in patients receiving monthly ranibizumab injections. Specifically, in the PDS group, mean visual acuity improved by 0.2 letters from baseline, and 98.4% of patients maintained the fixed six-month refill schedule during the first refill cycle. In patients receiving monthly ranibizumab injections, mean visual acuity improved by 0.5 letters from baseline. According to prespecified study criteria, the PDS demonstrated non-inferiority, being equivalent to monthly ranibizumab injections.

Furthermore, the Port Delivery System (PDS) demonstrated comparable efficacy to monthly ranibizumab in controlling retinal thickness, with the mean change in central subfield thickness from baseline being within 10 μm in both groups. In the study, patients tolerated PDS implantation and refilling well; PDS exhibited a favorable benefit-risk profile, with safety comparable to that of monthly ranibizumab injections.

Notably, PDS is the first therapy for neovascular age-related macular degeneration (nAMD) to achieve positive Phase III results with an extended treatment interval. Based on the results of the Archway study, PDS has the potential to reduce the number of treatments for nAMD patients from 12 times per year to twice per year without compromising efficacy, thereby significantly reducing the treatment burden on patients.

The results of the Archway study will be submitted to regulatory authorities worldwide to support regulatory approval of PDS for the treatment of nAMD. In addition to Archway, the Portal long-term extension study is investigating the long-term safety and tolerability of PDS for the treatment of nAMD. Furthermore, the Phase III Pagoda trial is evaluating PDS for the treatment of diabetic macular edema and is currently enrolling patients.

Reference Source: Phase III data show Roche’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration