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Carl Danzig, Carlos Quezada, Karen Basu, Susanna Grzeschik, Jayashree Sahni, David Silverman, Aaron Osborne; Efficacy and safety of faricimab every 16 or 12 weeks for neovascular age-related macular degeneration: STAIRWAY phase 2 results. Invest. Ophthalmol. Vis. Sci. 2019;60(9):1212.
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Angiopoietin-2 (Ang-2) signaling is associated with vascular destabilization and microvascular inflammation. Faricimab, the first bispecific antibody designed for intraocular use, binds and neutralizes both Ang-2 and vascular endothelial growth factor-A (VEGF-A). STAIRWAY (NCT03038880) assessed the efficacy and safety of 16- (q16w) and 12-week (q12w) faricimab in patients with neovascular AMD (nAMD).
STAIRWAY was a 52-week phase 2 study that enrolled patients aged ≥50 years with nAMD and subfoveal choroidal neovascularization, who were randomized 2:2:1 to intravitreal 6.0 mg faricimab, q16w or q12w after initiation, or 0.5 mg ranibizumab every 4 weeks (q4w). The primary objective was to evaluate the efficacy of faricimab administered at 16- and 12-week intervals, assessed by best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letter score). At week 24, 12 weeks after the last loading dose, a disease assessment was performed according to prespecified criteria, which included: BCVA, central subfield thickness, presence of new macular hemorrhage, and clinical signs of disease activity that in the investigator’s opinion required immediate treatment. Patients randomized to the q16w arm who had active disease at week 24 received treatment every 12 weeks through the trial end.
STAIRWAY enrolled 76 patients with nAMD. At week 24, 12 weeks after their previous injection, 65% (36/55) of faricimab-treated patients had no disease activity. Faricimab-treated patients had rapid initial BCVA gains that were maintained throughout the study with q16w and q12w dosing. At week 52, mean BCVA gains from baseline were 11.4, 10.1, and 9.6 letters for patients randomized to the faricimab q16w, faricimab q12w, and ranibizumab q4w arms, respectively, with 46.4%, 33.3%, and 37.5% of patients, respectively, gaining ≥15 letters from baseline. No new or unexpected safety signals were identified.
At week 52, q16w and q12w faricimab dosing resulted in full maintenance of initial BCVA gains and anatomic improvements that were comparable to q4w ranibizumab with no new or unexpected safety signals. The results suggest a role for combined inhibition of Ang-2 and VEGF in extending the durability of treatment that warrants further investigation. A global phase 3 clinical trial program for faricimab in nAMD will be initiated in 2019.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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