Astellas Announces Positive Two-Year Phase 3 Data for Novel Ophthalmic Drug Izervay in Geographic Atrophy

▎WuXi

Edited by Kant Content Team

Astellas Pharma released the latest results of the GATHER2 Phase III clinical trial, showing that its product avacincaptad pegol (brand name: Izervay), an intravitreal injection, effectively slowed the progression of geographic atrophy (GA) caused by age-related macular degeneration (AMD) in patients over a continuous two-year period.

Compared with the sham control group,Patients receiving Izervay treatment monthly showed a statistically significant 14% reduction (p=0.0165) in the mean growth rate of GA lesions after two years., achieving the pre-specified primary endpoint of the second-year analysis of the GATHER2 trial.

In addition, compared with the sham control group,The patient inAfter monthly administration in the first year and once every two months administration of Izervay in the second year, the average growth rate of GA lesions in the second year was significantly reduced by 19% (p=0.0015).

Over a two-year period, the safety profile of Izervay remained favorable, including one case of non-serious intraocular inflammation (IOI) and one case of culture-positive endophthalmitis. Importantly, no cases of ischemic optic neuropathy or retinal vasculitis were reported, demonstrating good tolerability of the drug.

Izervay is a complement C5 protein inhibitor developed by Iveric Bio.By targeting the C5 protein, Izervay has the potential to inhibit complement system activation, thereby preventing retinal cell atrophy and the progression of geographic atrophy.In July 2023, Astellas completed the acquisition of Iveric Bio, thereby obtaining the therapy.