Iveric Bio Announces 24-Month Topline Results from Phase 3 Study of Izervay for Geographic Atrophy
Astellas Pharma, the parent company of Iveric Bio, announced positive 24-month topline results from the phase 3 GATHER2 clinical trial evaluating the efficacy and safety of Izervay (avacincaptad pegol intravitreal solution), a recently approved complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Topline results demonstrated that the Izervay monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. Additionally, the treatment effect with the every other month dosing regimen for Izervay showed a similar reduction in the rate of GA growth versus sham, according to a company news release.
Overall, safety after 24 months of treatment was consistent with previously reported 12-month data, with no new safety signals identified. There was one case of culture-positive endophthalmitis and one case of non-serious intraocular inflammation. There were no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy. The rate of choroidal neovascularization (CNV) was 12% in patients treated with Izervay and 9% in those treated with sham.
“We are excited about these results, which show that Izervay continued to slow the rate of GA growth with a consistent safety profile after 2 years of treatment. We look forward to sharing results at a future scientific congress and with regulatory agencies," Dhaval Desai, PharmD, Senior Vice President and Chief Development Officer, Iveric Bio, said in a company news release.
Izervay was approved by the FDA on August 4, 2023, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and is currently under review by the European Medicines Agency.
To view EyewireTV's coverage of the FDA approval of Izervay, including an exclusive interview with Iveric Bio President Pravin Dugel, MD, click here.
About the GATHER2 Clinical Trial
GATHER2 (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). The primary objective at 24 months was to demonstrate whether, after re-randomization at 12 months, ACP slowed the GA growth rate (slope) in the EM treatment arm compared to sham.