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The Efficacy and Safety of Avacincaptad Pegol in Geographic Atrophy: 2-Year Results From GATHER2
Presenter:
Michael Ip, MD
Authors:
Michael Ip, MD 1; Arshad M. Khanani, MD, MA2,3; Peter K. Kaiser, MD4; Jeffrey S. Heier, MD5; Julie Clark, MD6; Hersh Patel, OD6; Don Luo, PhD6; Nikhil Patel, PharmD6; Glenn J. Jaffe, MD7; on behalf of the GATHER2 trial investigators
1Doheny Eye Institute, UCLA Department of Ophthalmology, Pasadena, CA, USA; 2Sierra Eye Associates, Reno, NV, USA; 3University of Nevada, Reno School of Medicine, Reno, NV, USA; 4Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA; 5Ophthalmic Consultants of Boston, Boston, MA, USA; 6Iveric Bio, An Astellas Company, Parsippany, NJ, USA; 7Department of Ophthalmology, Duke University, Durham, NC, USA.
Affiliation:
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.