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  • Port Delivery System Noninferior to Anti-VEGF Injections

    By Lynda Seminara
    Selected by Stephen D. McLeod, MD
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    Journal Highlights

    Ophthalmology, March 2022

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    Holekamp et al. evaluated the effec­tiveness of the port delivery system (PDS) with ranibizumab in patients with neovascular age-related macular degeneration (AMD). They found that the system met its objective for visual acuity and was noninferior to intravit­real injections of the anti-VEGF agent.

    The PDS includes a surgically placed permanent refillable ocular implant that continuously delivers ran­ibizumab into the vitreous. During patient visits, the implant reservoir can be refilled through a self-sealing septum in the center of the implant flange. The PDS is now FDA-approved and marketed as Susvimo (Genentech).

    This phase 3 study, known as Archway, was an open-label, randomized, active-com­parator trial that took place in 78 U.S. centers. Assessors were unaware of treatment assignment. Enrollees had a diagnosis of neovascular AMD within nine months of screening and had re­sponded to intravitreal anti-VEGF ther­apy. They were assigned randomly (3:2) to receive either ranibizumab treatment (100 mg/mL) via the implant with fixed 24-week refill-exchanges (Q24W) or intravitreal ranibizumab (.5 mg) every four weeks (monthly ranibizumab). The main outcome measure was change in best-corrected visual acuity (BCVA) letter score from baseline. The noninfe­riority margin was –4.5 letters, and the equivalence margin was ±4.5 letters.

    Altogether, 248 patients received the implant, and 167 received intravitreal ranibizumab. Baseline BCVA was 74.4 letters in the PDS group and 75.5 letters in the intravitreal group. The adjust­ed mean change in BCVA score from baseline, averaged over weeks 36 to 40, was +.2 letters (standard error [SE], .5 letters) in the PDS-Q24W arm and +.5 letters (SE, .6 letters) in the monthly intravitreal arm. PDS-Q24W proved noninferior and equivalent to monthly ranibizumab injection. Among 246 PDS-treated patients evaluated for sup­plemental ranibizumab, 242 (98.4%) did not need it before the refill. Pre­specified adverse events of interest were reported for 19% of the PDS arm and 6% of the intravitreal arm. Most such events in the PDS arm occurred within a month of implantation.

    The original article can be found here.