Outlook Therapeutics, Inc. (NASDAQ:), a biopharmaceutical company, today announced preliminary topline results from its NORSE EIGHT clinical trial, which evaluated ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD (NASDAQ:)).
The trial did not meet its pre-specified non-inferiority endpoint at week 8 compared to ranibizumab. Despite this, preliminary data indicated an improvement in vision and confirmed biologic activity and safety of the treatment.
OTLK shares slumped 80% on the news.
ONS-5010, also known as LYTENAVA, has already received regulatory approval in the European Union and the United Kingdom (TADAWUL:) earlier this year for the treatment of wet AMD. The biopharmaceutical company is planning to resubmit a Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025, following a complete analysis of the NORSE EIGHT trial’s month 3 data, which is expected to be available in January 2025.
The NORSE EIGHT trial’s primary measure was the mean change in best corrected visual acuity (BCVA) from baseline to week 8. Results showed a mean increase of +4.2 BCVA letters in the ONS-5010 arm and +6.3 BCVA letters in the ranibizumab arm.
The difference in means between ONS-5010 and ranibizumab was -2.257 BCVA letters, with a 95% confidence interval of (-4.044, -0.470). The lower bound of the non-inferiority margin set in the special protocol assessment (SPA) with the FDA was -3.5 at a 95% confidence interval; therefore, the noninferiority hypothesis was not confirmed (p>0.025).
Despite the trial results, Outlook Therapeutics expressed confidence in ONS-5010/LYTENAVA™ as an important therapy for wet AMD. The company is continuing with its plans for a potential 2025 launch in the UK and Germany, where the treatment has received Marketing Authorization. ONS-5010 is positioned as an alternative to off-label repackaged bevacizumab, which has not been approved for ophthalmic use.
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