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Beitragstitel	The efficacy and safety of avacincaptad pegol in geographic atrophy: 2-year results from GATHER2
Beitragscode	P26
Autor:innen	Silvia Gluderer Astellas Pharma AG Präsentierende:r Arshad Khanani Sierra Eye Associates Peter Kaiser Cole Eye Institute, Cleveland Clinic Jeffrey Heier Ophthalmic Consultants of Boston Michael Ip Doheny Eye Institute Julie Clark Formerly Iveric Bio, An Astellas Company Hersh Patel Iveric Bio, An Astellas Company Don Luo Iveric Bio, An Astellas Company Nikhil Patel Iveric Bio, An Astellas Company Glenn Jaffe Department of Ophthalmology, Duke University
Präsentationsform	ePoster
Themengebiete	Retina Vitreous
Abstract-Text	Purpose Avacincaptad pegol (ACP), a pegylated RNA aptamer complement C5 inhibitor, is an FDA-approved intravitreal treatment for geographic atrophy (GA). ACP 2 mg achieved the 1-year primary objective in two phase 3 studies (GATHER1 and GATHER2). Topline 2-year results from GATHER2 will be reported. Methods GATHER2 was a randomized, double-masked, sham-controlled study in patients with non-centerpoint-involving GA. Patients were randomized 1:1 to receive monthly ACP 2 mg (n=225) or sham (n=222). At month 12, patients receiving ACP 2 mg were re-randomized 1:1 to receive monthly (n=96) or every-other-month (n=93) ACP 2 mg (final follow-up visit month 24). At month 12, patients who had received sham continued to receive sham (n=203). The 2-year objective was to demonstrate if ACP 2 mg dosed monthly or every other month reduced observed GA growth (slope) vs sham up to 2 years as assessed by GA area measured on fundus autofluorescence at 5 time points (baseline, month 6, 12, 18, and 24). Safety outcomes were also assessed. Results The primary objective was met at year 1. Treatment with monthly ACP 2 mg resulted in statistically significant reductions of 0.056 mm/yr (p=0.006) in GA growth (slope) compared with sham using both square-root-transformed data and 0.376 mm2/yr (p=0.004) using observed data. Results were consistent with the 2-year objective. At 2 years, treatment with ACP 2 mg demonstrated a continued reduction in GA growth (slope) with both monthly and every other month dosing vs sham. Over 1 year, there were no events of endophthalmitis, intraocular inflammation, retinal vasculitis, or ischemic optic neuropathy. Choroidal neovascularization (CNV) occurred in the study eye in 7% of patients for ACP 2 mg and 4% of patients for sham in year 1. Safety over 2 years was consistent with 1-year data, with no new safety signals identified. Specifically, no cases of retinal vasculitis or ischemic optic neuropathy were reported. One case of culture-positive endophthalmitis and 1 case of non-serious intraocular inflammation were reported. Over 2 years, CNV occurred in the study eye in 12% of patients for ACP 2 mg and 9% of patients for sham. Conclusion The 2-year results from GATHER2 demonstrated the continued safety and tolerability of ACP 2 mg and that monthly and every other month dosing regimens for ACP 2 mg continued to slow the rate of GA growth vs sham.