Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration

Abstract

Abstract

Objective: To report 2-year efficacy and safety outcomes of 2 dosing regimens of abicipar (every 8 weeks and quarterly, after initial doses) compared with monthly ranibizumab in patients with treatment-naive neovascular age-related macular degeneration (nAMD).

Design: Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR/SEQUOIA). Analyses used pooled trial data.

Participants: The trials enrolled 1888 patients (1 eye/patient) with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters.

Methods: At enrollment, patients were assigned to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (abicipar Q8, n = 630), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (abicipar Q12, n = 628), or ranibizumab 0.5 mg every 4 weeks (ranibizumab Q4, n = 630).

Main outcome measures: Efficacy measures included stable vision (<15-letter loss in BCVA from baseline) and change from baseline in BCVA and central retinal thickness (CRT). Safety measures included adverse events (AEs).

Results: For patients who completed the study, efficacy of abicipar after initial doses was maintained through week 104. At week 104, the proportion of patients with stable vision was 93.0% (396/426), 89.8% (379/422), and 94.4% (470/498); mean change in BCVA from baseline was +7.8, +6.1, and +8.5 letters, and mean change in CRT from baseline was -147, -146, and -142 μm in the abicipar Q8 (14 injections), abicipar Q12 (10 injections), and ranibizumab Q4 (25 injections) groups, respectively. The overall incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3% from baseline through week 52 and 16.2%, 17.6%, and 1.3% from baseline through week 104 in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively.

Conclusions: Two-year results show efficacy of abicipar Q8 and Q12 in nAMD. First onset of IOI events with abicipar was much reduced in the second year and comparable to that with ranibizumab (0.8% and 2.3% vs 1.0%). The extended duration of effect of abicipar allows for quarterly dosing and reduced treatment burden.