IVERIC bio Inc

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Iveric Bio Receives FDA Agreement Under Special Protocol Assessment (SpA) For Gather2 Phase 3 Clinical Trial Of Zimura® In Geographic Atrophy Secondary To Age-Related Macular Degeneration

Published: 07/06/2021 10:35 GMT
IVERIC bio Inc (ISEE) - Iveric Bio Receives FDA Agreement Under Special Protocol Assessment (spa) for Gather2 Phase 3 Clinical Trial of Zimura® in Geographic Atrophy Secondary to Age-related Macular Degeneration.
Iveric Bio Inc - Completion of Enrollment Expected Late July of This Year and Topline Data Expected Second Half of 2022.
Iveric Bio Inc - FDA Recommended, and Company Accepted, Modifying Primary Efficacy Endpoint for Gather2 Trial.
Iveric Bio Inc - Submitted, and FDA Reviewed, a Revised Clinical Trial Protocol and Statistical Analysis Plan (sap) for Gather2 Trial.
Iveric Bio- FDA Indicated, As Part of Future NDA Submission for Zimura, Gather1 Results Will Be Considered Using Original Prespecified Primary Efficacy Endpoint Analysis.