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  • Quarterly Abicipar Is Not Inferior to Monthly Ranibizumab

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

    Ophthalmology, October 2020

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    Abicipar is a designed ankyrin-repeat protein that binds VEGF with higher affinity and longer intraocular per­sistence than ranibizumab. Kunimoto et al. compared abicipar administered every eight or 12 weeks to ranibizumab given at four-week intervals in patients with treatment-naive neovascular age-related macular degeneration (AMD). The treatments were comparable in terms of vision stability; however, the rate of intraocular inflammation was higher with abicipar.

    For their study, the authors pooled 52-week results of two randomized phase 3 trials (CEDAR and SEQUOIA), which had identical protocols. Patients (n = 1,888) had been assigned to one of three groups. The Q8 group received 2 mg of abicipar initially (baseline, week 4, week 8) and every eight weeks thereafter. Similarly, the Q12 group had 2-mg loading doses of abicipar (baseline, week 4, week 12) followed by the same dose at 12-week intervals. The ranibizumab group received standard dosing of 0.5 mg every four weeks.

    The main outcome measure was the proportion of patients with stable vision, defined as best-corrected visual acuity (BCVA) decline of less than 15 letters from baseline. Secondary end­points were mean changes in BCVA and central retinal thickness (CRT). Adverse events were mon­itored throughout the study.

    At week 52, neither abicipar regimen was inferior to ranibizumab in the prima­ry or secondary efficacy measures. The proportion of patients with stable vision was 93.2% in the ab­icipar Q8 group, 91.3% in the abicipar Q12 group, and 95.8% in the ranibizumab group. Mean BCVA gains from baseline were 7.5, 6.4, and 8.4 letters, respectively. The mean decrease in CRT was similar for all groups. Although the adverse event rates were similar, intraocular inflam­mation was more common in patients who received abicipar (15% vs. 0.3%). Because of this, study discontinuation and severe vision loss occurred more frequently with abicipar. Modified drug-purification strategies are being explored to reduce the risk of intraocular inflam­mation with abicipar.

    The original article can be found here.