Outlook Therapeutics' wet AMD therapy ONS-5010 clinical trial did not meet the primary endpoint
Outlook Therapeutics announced that its clinical trial for the wet age-related macular degeneration (AMD) therapy ONS-5010 did not meet its primary endpoint, causing the stock price to plummet about 82% in pre-market trading on Wednesday. Nevertheless, the company stated that ONS-5010 has biological activity and good safety, planning to resubmit its listing application in the first quarter of 2025, and expects to announce the three-month data analysis results in January next year
According to the Zhitong Finance APP, Outlook Therapeutics (OTLK.US) announced that its investigational therapy ONS-5010 for the treatment of wet age-related macular degeneration (AMD) failed to meet its primary endpoint in clinical trials, causing the stock to plummet approximately 82% in pre-market trading on Wednesday.
The biotechnology company, headquartered in Iselin, New Jersey, cited top-line data from its NORSE EIGHT trial, indicating that ONS-5010 (also known as Lytenava) did not achieve the pre-specified non-inferiority endpoint after about two months.
However, Outlook noted that the drug demonstrated biological activity, vision improvement, and good safety, stating plans to resubmit the NDA for ONS-5010 in the U.S. in the first quarter of 2025 after completing data analysis.
Data analysis for NORSE EIGHT is currently underway, with three-month data from the study expected to be released in January next year. In August, the U.S. Food and Drug Administration (FDA) refused to approve ONS-5010 for wet AMD, citing specific manufacturing issues and the need for additional clinical evidence.
Nonetheless, the company plans to launch the drug in the European Union and the UK next year, as Lytenava has already received approval for the treatment of wet AMD in these two regions