Outlook Therapeutics' ONS-5010 misses key endpoint in NORSE EIGHT trial; BLA resubmission planned Q1 2025

Outlook Therapeutics, Inc.

ONS-5010 did not meet non-inferiority endpoint at week 8 vs ranibizumab (difference -2.257 BCVA letters, margin -3.5).
Mean BCVA improvement: ONS-5010 +4.2 letters, ranibizumab +6.3 letters (p=0.0863).
Favorable safety profile: no retinal vasculitis, ocular AE rates comparable to ranibizumab.
Final month 3 data expected Jan 2025; BLA resubmission to FDA in calendar Q1 2025.
EU/UK marketing authorization already granted; launch in UK and Germany planned for 2025.

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