The US FDA declined to approve the firm’s investigational drug Lytenava for the treatment of wet age-related macular degeneration, citing a lack of substantial evidence of effectiveness.
Outlook Therapeutics, Inc. (OTLK) announced on Thursday that the U.S. Food and Drug Administration has declined to approve its investigational drug Lytenava for the treatment of wet age-related macular degeneration. Shares of the company nose-dived over 66% in Thursday’s pre-market session following the announcement.
The agency cited a lack of substantial evidence of effectiveness as the basis for its decision. Age-related macular degeneration causes damage to the macula, a small area near the center of the retina, which is the part of the eye responsible for sharp, central vision. It is common among people aged 50 and older. Wet age-related macular degeneration (wet AMD) is an advanced form of AMD where abnormal, leaky blood vessels grow under the retina, leading to rapid vision loss.
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