Astellas : Izervay Monthly Or Every Other Month Reduced GA Lesion Growth Through 2 Years

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced results from the GATHER2 Phase 3 clinical trial, demonstrating Izervay (avacincaptad pegol intravitreal solution) continued to reduce the rate of geographic atrophy lesion growth for both every month or EM and every-other-month or EOM dosing compared to sham through 2 years of treatment in patients with GA secondary to age-related macular degeneration or AMD.

The geographic atrophy or GA treatment benefit with Izervay compared to sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1.

Izervay dosed EM through 2 years demonstrated a statistically significant year-over-year reduction of 14% in the mean rate of GA growth at 2 years from baseline vs. sham , the primary objective of the year 2 analyses from GATHER2.

EOM dosing of Izervay, after a year of monthly dosing, resulted in a reduction of 19% in the mean GA growth rate at 2 years vs. sham.

Izervay treatment effect more than doubled over 2 years compared to 1 year.

The prespecified objective of demonstrating that Izervay reduced the rate of =15-letter persistent vision loss compared to sham over 2 years was not statistically significant. Persistent vision loss will be further explored across several sensitivity analyses.

The company noted that Izervay was well tolerated over 2 years, with one case each of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis. There were no cases of ischemic neuropathy or retinal vasculitis.

Over 2 years, only a slight increased incidence of choroidal neovascularization (CNV) was observed for Izervay pooled vs. sham. In year 2, the incidence of CNV was similar for Izervay EOM vs. sham.

Izervay was approved by the U.S. Food and Drug Administration on August 4, 2023, for the treatment of geographic atrophy secondary to age-related macular degeneration and is currently under review by the European Medicines Agency.

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