Outlook Therapeutics is remaining hopeful that the US Food and Drug Administration will approve ONS-5010 for wet age-related macular degeneration (AMD) despite the Phase III NORSE EIGHT study not meeting its primary endpoint of noninferiority, based on evidence that the drug still has biological activity.
Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss
The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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