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Ophthalmic Surg Lasers Imaging Retina. 2019 Feb 1;50(2):e10-e22. doi: 10.3928/23258160-20190129-13.

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. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:e10-e22.].

PMID:
30768224
DOI:
10.3928/23258160-20190129-13
[Indexed for MEDLINE]

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