Abstract
Purpose :
Faricimab, the first bispecific antibody designed for intraocular use, can simultaneously bind and neutralize angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A). The phase 2 STAIRWAY (NCT03038880) trial assessed extended durability of faricimab for the treatment of neovascular age-related macular degeneration (nAMD).
Methods :
STAIRWAY was a 52-week, multicenter, randomized, active comparator–controlled, parallel-group, phase 2 trial. Patients with nAMD were randomized 2:2:1 to faricimab 6.0 mg every 16 weeks (Q16W) flex or every 12 weeks (Q12W) fixed (both with 4 every-4-week [Q4W] initiation injections) or ranibizumab 0.5 mg Q4W. All patients were treatment-naïve prior to entering the study. Disease activity was assessed using prespecified criteria 12 weeks after the last faricimab initiation injection, at week 24 of the trial. The faricimab Q16W–assigned patients without protocol-defined disease activity continued Q16W dosing. Patients with disease activity continued on Q12W dosing. No rescue treatment was allowed.
Results :
Improvements in best-corrected visual acuity, reductions in central subfield thickness on spectral domain optical coherence tomography (SD-OCT), choroidal neovascularization (CNV) lesion size, and area of leakage on fluorescein angiography with faricimab Q16W flex and Q12W were comparable with ranibizumab Q4W. No new or unexpected safety signals were identified. At week 52, change from baseline in total lesion area was –4.2, –5.4, and –4.5 mm2 for the faricimab Q16W flex, faricimab Q12W, and ranibizumab Q4W arms, respectively; change from baseline in CNV component area was –4.3, –5.6, and –4.8 mm2, respectively. Change from baseline in leakage area was –4.6, –5.6, and –5.3 mm2, respectively. Vision and macular anatomy were maintained with approximately half as many injections of faricimab Q16W flex or Q12W fixed versus ranibizumab Q4W dosing.
Conclusions :
Faricimab dosed at extended Q16W/Q12W intervals provided sustained anatomic and visual outcomes comparable with ranibizumab Q4W.
This is a 2020 ARVO Annual Meeting abstract.