Outlook Therapeutics’ ONS-5010 Fails to Meet Primary Endpoint in Wet AMD Trial, Stock Plummets
Outlook Therapeutics Inc. (OTLK) experienced a significant setback today with the release of preliminary topline results from NORSE EIGHT, its second clinical trial evaluating ONS-5010 for the treatment of wet age-related macular degeneration (AMD). The trial, designed to assess the non-inferiority of ONS-5010 compared to Roche’s Lucentis (ranibizumab), failed to meet its primary endpoint at the 8-week mark, as defined in the Special Protocol Assessment (SPA) agreed upon with the Food and Drug Administration (FDA).
The key metric, mean change in best-corrected visual acuity (BCVA) from baseline to week 8, revealed a difference of -2.257 BCVA letters between ONS-5010 and Lucentis. This falls short of the pre-specified non-inferiority margin of -3.5, resulting in a failure to meet the statistical hypothesis (p>0.025). While the intent-to-treat (ITT) primary dataset showed a mean BCVA improvement of +4.2 letters for ONS-5010 and +6.3 letters for ranibizumab, the non-inferiority margin was not achieved.
Despite this disappointing result, the preliminary data did reveal a notable improvement in vision and evidence of biological activity for ONS-5010. Importantly, the drug maintained a favorable safety profile throughout the trial. Outlook Therapeutics is optimistic and remains committed to the potential of ONS-5010. The company is currently analyzing the complete month 3 data from NORSE EIGHT, which is anticipated to be available in January 2025.
This data will be pivotal for the company’s plans. Outlook Therapeutics intends to leverage this additional data to resubmit its U.S. marketing application for ONS-5010 in the first quarter of 2025. It’s a strategic move demonstrating their belief in the drug’s long-term prospects despite the current setback. The company has already secured Marketing Authorization for ONS-5010/Lytenava (bevacizumab gamma) in the European Union and the U.K., and plans to launch the product in Europe in 2025, either directly or through a licensing partner. Furthermore, if FDA approval is granted, Outlook Therapeutics plans to commercialize ONS-5010/Lytenava (bevacizumab-vikg) directly within the United States. They’re also exploring partnering options for Lytenava in Europe and other regions outside the U.S.
The news sent shockwaves through the market, with OTLK stock experiencing a dramatic 80% drop to $0.97 during the pre-market session on Wednesday. This sharp decline underscores the market’s sensitivity to the trial’s outcome and the implications for the company’s future prospects. The path forward remains uncertain, but Outlook Therapeutics is banking on the full data analysis to support their renewed application and the ultimate success of ONS-5010 in treating wet AMD. The market will closely watch the release of the complete month 3 data in January 2025 to assess the true potential of this drug.
