IVERIC bio Inc (NASDAQ: ISEE) announced positive data from the second Phase 3 trial of Zimura (avacincaptad pegol) for geographic atrophy (GA).
GATHER2 met its prespecified primary endpoint of mean growth rate (slope) in GA area at 12 months with statistical significance and a favorable safety profile.
Zimura showed a 14.3% reduction in the mean growth rate (slope) in GA area over 12 months using square root transformation and a 17.7% reduction using the observed GA area.
Post-hoc Analysis of U.S. Patients showed a 25.5% reduction and 32.0%, respectively.
In GATHER2, there were no events of endophthalmitis, no intraocular inflammation events, and ischemic optic neuropathy events. The most frequently reported ocular adverse events were related to the injection procedure.
Zimura 2 mg reduced all analyzed subgroups' mean growth rate (slope) in the GA area.
For best corrected visual acuity, a favorable trend for Zimura 2 mg was observed consistent with GATHER1. A favorable trend was not observed for low luminance best corrected visual acuity.
The company plans to submit a marketing application to the FDA by the end of Q1 2023.
https://finance.yahoo.com/news/iveric-bio-stock-soars-encouraging-115127252.html
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