Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Patients With Neovascular Age-Related Macular Degeneration: Studies in Japan and the United States

Abstract

BACKGROUND AND OBJECTIVE: To evaluate comparability of abicipar pegol (abicipar) effects in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in Japan and the United States. PATIENTS AND METHODS: Phase 2, multicenter, randomized, double-masked, 20-week studies (BAMBOO, Japan; CYPRESS, United States). Patients (n = 25 each study) received three monthly intravitreal injections of abicipar 1 mg or 2 mg or five monthly intravitreal injections of ranibizumab 0.5 mg. RESULTS: Mean best-corrected visual acuity change from baseline at week 16 (primary endpoint) for abicipar 1 mg, abicipar 2 mg, and ranibizumab was +7.8 letters, +8.9 letters, and +17.4 letters (BAMBOO); +4.4 letters, +10.1 letters, and +15.2 letters (CYPRESS). Mean central retinal thickness change from baseline was −187.3 μm, −196.5 μm, and −230.4 μm (BAMBOO); −106.5 μm, −112.8 μm, and −124.4 μm (CYPRESS). Uveitis or vitritis was reported in three abicipar-treated patients. CONCLUSION: Abicipar demonstrated extended duration of effect and safety that were comparable between Japanese and non-Japanese patients with nAMD. Abicipar effectively treated Japanese patients with polypoidal choroidal vasculopathy.

Changes in complement activation products after anti-VEGF injection for choroidal neovascularization in age-related macular degeneration and pachychoroid disease

“…Noninfectious inflammation was reported after anti-VEGF injections 34 . Although the incidence was very low, most anti-VEGF agents have caused inflammation after intravitreal injections 36 – 38 . Complement dysregulation may be a predisposing factor after the anti-VEGF treatment.…”

Changes in complement activation products after anti-VEGF injection for choroidal neovascularization in age-related macular degeneration and pachychoroid disease

“…Noninfectious in ammation was reported after anti-VEGF injections 37 . Although the incidence was very low, most anti-VEGF agents have caused in ammation after intravitreal injections [38][39][40] . The complement dysregulation may be one of predisposing factors after the treatment.…”

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

“…Results of three phase 2 studies of abicipar in patients with treatment-naïve nAMD suggested a potential for abicipar 2 mg to improve or maintain vision in patients with quarterly dosing. 12,13 J o u r n a l P r e -p r o o f Subsequently, two 2-year phase clinical trials (CEDAR and SEQUOIA) with identical protocols compared abicipar 2 mg every 8 or 12 weeks after initial doses (Q8 or Q12) to ranibizumab 0.5 mg every 4 weeks (Q4) in patients with treatment-naïve nAMD. We recently reported the pooled phase 3 study results through 1 year.…”