Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study
Roger A. Goldberg, David S. Boyer, Frank G. Holz, Mathew W. MacCumber, Sunir J. Garg, David M. Brown, Eleonora M. Lad, Nathan Steinle, P. Singh Rishi, Ian Pearce, Thomas Ach, Ramiro Ribeiro, Chao Li, Daniel W. Jones, Min Tsuboi, Philip J. Ferrone, Caroline R. Baumal, Charles C. Wykoff
Abstract
BACKGROUND AND OBJECTIVE: This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). PATIENTS AND METHODS: GALE is a phase 3, open-label, multicenter, 36-month extension of the OAKS and DERBY studies. Patients who received pegcetacoplan monthly (PM) or every other month (PEOM) in OAKS or DERBY continued the same regimen in GALE (PM-PM and PEOM-PEOM); sham-observed patients initiated pegcetacoplan, maintaining the same interval. RESULTS: In the first 6 months of GALE, 3.0% of study eyes developed exudative AMD, 1.3% intraocular inflammation, 0.1% ischemic optic neuropathy, and none endophthalmitis. Pegcetacoplan reduced GA growth rate by 39% (PM-PM) and 32% (PEOM-PEOM), with increasing efficacy over time across GA subtypes. In eyes with nonsubfoveal GA, pegcetacoplan reduced GA growth rate by 45% (PM-PM) and 33% (PEOM-PEOM). CONCLUSION: .