Outlook Therapeutics (OTLK.US) wet AMD therapy ONS-5010 fails to meet primary endpoint in clinical trial
1min read Outlook Therapeutics(OTLK.US) said its clinical trial for its investigational therapy ONS-5010 for the eye disease wet age-related macular degeneration (AMD) failed to meet its primary endpoint, sending the stock down about 82% before the market opened on Wednesday.
The New Jersey-based biotechnology company cited top-line data from its NORSE EIGHT trial that ONS-5010 (also known as Lytenava) did not meet the pre-specified non-inferiority endpoint about two months later.
However, Outlook noted the drug's biologic activity, visual improvement, and good safety, and said it plans to resubmit an application for ONS-5010's commercialization in the first quarter of 2025 in the U.S. after completing data analysis.
The data analysis for NORSE EIGHT is ongoing, and the three-month data from the study is expected to be released in January next year. In August, the FDA rejected ONS-5010 for wet AMD, citing specific manufacturing issues and the need for additional clinical evidence.
However, the company plans to launch the drug in the EU and UK next year, and Lytenava has already been licensed for the treatment of wet AMD in both regions.