IVERIC bio, Inc. (NASDAQ: ISEE) saw its shares fall slightly at the open Tuesday, on announcing it received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the Company’s pivotal clinical trial of Zimura ® (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Also, the Company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, the Company expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis.
Similar to the Company’s completed GATHER1 clinical trial, GATHER2 is designed to be an adequate and well-controlled clinical trial which, if positive, would support a New Drug Application (NDA) for Zimura in the treatment of GA secondary to AMD. The SPA agreement further solidifies the Company’s plans to file an application with the FDA if the ongoing GATHER2 clinical trial meets its primary efficacy endpoint at 12 months.
"We are excited to receive this SPA agreement from the FDA," stated company President Pravin U. Dugel.
"We look forward to continuing to work with the FDA and following their guidance as we work toward preparing the eventual NDA submission for Zimura."
ISEE shares dived 18 cents, or 2.2%, to $7.76.
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