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Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

 
• By Alaric DeArment

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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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.

The company said on 27 November that NORSE EIGHT did not meet the prespecified noninferiority endpoint at week 8, as set forth in a special protocol assessment (SPA) with the FDA, but the data nevertheless showed improvement in vision and presence of biological activity, along with a favorable safety profile

Key Takeaways
  • Outlook said the NORSE EIGHT trial did not meet its primary endpoint of showing that ONS-5010 was noninferior to ranibizumab at eight weeks, but it will file for US FDA approval anyway.
  • Despite the primary endpoint miss, the company remains hopeful about FDA approval, though one analyst said the results cloud its prospects

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