Astellas Pharma has announced positive 24-month topline results from the GATHER2 Phase 3 clinical study of IZERVAY, developed by its subsidiary Iveric Bio who recently secured regulatory approval in the US for the therapy.
IZERVAY, or avacincaptad pegol intravitreal (ACP) solution, is a complement C5 inhibitor for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
According to the company, results demonstrated that the IZERVAY monthly dosing regimen achieved the primary objective to significantly slow GA growth compared to placebo 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 placebo.
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 neovascularisation (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 two years of treatment. We look forward to sharing results at a future scientific congress and with regulatory agencies,” Dr Dhaval Desai, senior vice president and chief development officer of Iveric Bio, said.
IZERVAY was approved by the US Food and Drug Administration (FDA) in August 2023 for the treatment of GA secondary to age-related macular degeneration (AMD) and is currently under review by the European Medicines Agency (EMA).
According to the company, GATHER2 was a randomised, double-masked, placebo-controlled, multicentre phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of ACP solution in 448 enrolled patients with GA secondary to AMD.