Outlook Therapeutics Reveals Results of NORSE EIGHT Trial; Shares Drop

Biopharmaceutical company Outlook Therapeutics, Inc. (NASDAQ:OTLK) announced today the top-line results of the NORSE EIGHT clinical trial evaluating ONS-5010 for the treatment of wet age-related macular degeneration (wet AMD). The trial failed to meet its pre-specified non-inferiority endpoint compared to ranibizumab at week 8. Nevertheless, preliminary data showed improvements in visual acuity and confirmed the biological activity and safety of the treatment.

OTLK shares dropped by 80% on this news. ONS-5010, also known as LYTENAVA, received regulatory approval for the treatment of wet AMD in the European Union and the United Kingdom earlier this year. The biopharmaceutical company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar year 2025, following the full analysis of data from the 3-month results of the NORSE EIGHT trial, expected in January 2025.

The primary endpoint of the NORSE EIGHT trial was the mean change in best-corrected visual acuity (BCVA) from baseline to week 8. The results showed an average increase of +4.2 BCVA letters in the ONS-5010 group and +6.3 BCVA letters in the ranibizumab group. The mean difference 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 as established in the Special Protocol Assessment (SPA) with the FDA was -3.5 within the 95% confidence interval; therefore, the non-inferiority hypothesis was not confirmed (p>0.025).

Despite the trial outcomes, Outlook Therapeutics expressed confidence that ONS-5010/LYTENAVA™ represents a significant treatment for wet AMD. The company continues to pursue plans for a potential launch in 2025 in the United Kingdom and Germany, where the treatment has received Marketing Authorization approval. ONS-5010 is positioned as an alternative to repackaged bevacizumab, which is not approved for ophthalmic use.