In September, Astellas Pharma reported positive 24-month topline results from a phase 3 clinical trial evaluating the efficacy and safety of avacincaptad pegol intravitreal solution (Izervay; Iveric Bio), a complement C5 inhibitor recently approved by the US Food and Drug Administration (FDA) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Results from the GATHER2 study (NCT04435366) demonstrated that the Izervay monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. Additionally, an every-other-month dosing regimen of Izervay showed a similar reduction in the rate of GA growth versus sham. Safety after 24 months of treatment was consistent with previously reported 12-month data, with no new safety signals identified, the company reported in a press release.