The FDA has rejected Outlook Therapeutics’ ophthalmic formulation of bevacizumab for wet AMD, an eye disorder that can cause blurred vision or blind spots.
In their complete response letter, regulators noted “several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence,” Outlook said Wednesday.
The company’s stock $OTLK plunged more than 83% Wednesday morning to $0.23 per share.
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