IVERIC bio Inc. said Tuesday the U.S. Food and Drug Administration has agreed to the overall design of its clinical trial for its treatment of geographic atrophy secondary to age-related macular degeneration, sparking a premarket rally in its shares.
The investigational drug company said it received written agreement from the FDA under a special protocol assessment, a procedure that provides a clinical trial sponsor with an official evaluation and written guidance on the design of a proposed protocol intended to form the basis for a new drug application. It doesn't ensure the receipt of marketing approval or that the approval process will be faster than conventional regulatory procedures.
In premarket trading, IVERIC's shares were 32% higher after ending Friday at $7.94, up 15% so far in 2021
The company said it expects to complete enrollment in its GATHER2 study in late July, and topline data to be available in the second half of 2022, about one year after the enrollment of the last patient plus the time needed for database lock and analysis.
GATHER2 is designed to be well-controlled clinical trial that, if positive, would support a new drug application for Zimura in the treatment of geographic atrophy secondary to age-related macular degeneration. The special protocol assessment agreement firms 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, it said.
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