Susvimo noninferior to monthly ranibizumab with similar efficacy
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The Port Delivery System with ranibizumab was noninferior and had similar efficacy to monthly ranibizumab injections for the treatment of neovascular age-related macular degeneration, according to results from the Archway trial.
The novel treatment delivery method, which was approved by the FDA in October 2021 and is now known as Susvimo (Genentech), allows ranibizumab to be continuously delivered into the vitreous via a refillable ocular implant, reducing the treatment and monitoring burden.
The phase 3 open-label, randomized, visual acuity assessor-masked noninferiority and equivalence Archway trial included patients with neovascular AMD who were previously treated with and responsive to anti-VEGF therapy.
The study included 418 patients who were randomly assigned to treatment with the Port Delivery System (PDS) with ranibizumab 100 mg/mL with fixed 24-week refill exchanges or intravitreal ranibizumab 0.5 mg injections monthly.
The adjusted mean change in best corrected visual acuity from baseline, over weeks 36 and 40, was +0.2 letters in the PDS arm and +0.5 letters in the monthly injection arm. Ocular adverse events were reported in 47 patients (19%) in the PDS arm and 10 patients (6%) in the monthly injection arm. Most adverse events in the PDS arm occurred within 1 month of implantation.
“Supported by a strong patient preference over intravitreal injections, the PDS has the potential to help reduce frequent visits for treatment and to improve outcomes in patients with [neovascular] AMD in clinical practice,” Nancy M. Holekamp, MD, and colleagues wrote.
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