Efficacy and Safety of Abicipar in Neovascular Age-Related M
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Most cases of intraocular inflammation in patients with neovascular age-related macular degeneration (nAMD) who take Abicipar develop during the first year of treatment, according to a new report of two-year efficacy and safety results from a couple of pivotal trials.

Abiciparpegol, originally developed by Allergan, is an anti-VEGF drug with a longer duration of action than currently available agents, allowing it to be injected less frequently.

The analysis pooled results from CEDAR and SEQUOIA, two multicentre, randomized,double-masked, phase-3 clinical trials with identical protocols. The studies enrolled 1,888 nAMD patients with best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters.

Patients received either Abicipar 2 mg every 8 weeks after three initial doses at baseline and weeks 4 and 8 (Q8), Abicipar 2 mg every 12 weeks after three initial doses at baseline and weeks 4 and 12 (Q12), or Ranibizumab 0.5 mg every four weeks (Q4).

The efficacy of abicipar was maintained throughout treatment. At week 104, 93.0% of the patients in the abicipar Q8 group had stable vision (<15-letter loss in BCVA from baseline), compared to 89.8% in the abicipar Q12 group and 94.4% in the ranibizumab Q4 group.

Mean change in BCVA from baseline was +7.5, +6.4 and +8.4 letters, respectively, and mean change in central retinal thickness was -144 um, -145 um and -144 um.

Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids.

It was concluded that abicipar Q8 and Q12 were both non-inferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.

Source: https://www.aaojournal.org/article/S0161-6420(20)30320-1/fulltext
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