Acucela Inc.
Acucela Files Investigational New Drug Application
Published in Food and Drug Law Weekly, May 23rd, 2008
Acucela Inc., a clinical-stage biotechnology company focused on developing therapies for blinding eye diseases, announced that it has filed an investigational new drug (IND) application to conduct a Phase 1 clinical trial for its lead compound ACU-02 with the U.S. Food and Drug Administration (FDA). The filing follows a successful pre-IND meeting in Washington D.C. where the company reviewed its current pre-clinical efficacy and safety data as well as development plans with FDA.
ACU-02 is an orally available small molecule modulator of the visual cycle, which is thought to play a key role in the pathophysiology of the dry form of age-related macular degeneration (AMD),...
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