Japanese drug major Astellas Pharma (TYO: 4503) announced positive 24-month top-line results from the Phase III GATHER2 clinical trial evaluating the efficacy and safety of Izervay (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Top-line 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.
Astellas gained rights to the product through its recently completed buy of Iveric Bio for about $5.9 billon. Just last month Izervay gained US Food and Drug Administration (FDA) for the treatment of GA secondary to AMD, and is currently under review by the European Medicines Agency.
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