Outlook Therapeutics, Inc. (OTLK), a biopharmaceutical company, on Thursday announced the completion of the 12-week efficacy and safety results from its NORSE EIGHT clinical trial for ONS-5010, a treatment for wet age-related macular degeneration or wet AMD.
The trial demonstrated that ONS-5010 was non-inferior to ranibizumab, showing a 5.5 letter improvement in Best Corrected Visual Acuity or BCVA, compared to a 6.5 letter improvement with ranibizumab.
Additionally, the change in central retinal thickness was similar in both study arms.
The data supports Outlook Therapeutics' plan to resubmit its Biologics License Application or BLA for ONS-5010 in the first quarter 2025.
The company also reported that ONS-5010 was generally well-tolerated, with safety results consistent with previous trials.
In addition, Outlook Therapeutics entered into agreements for a warrant inducement transaction expected to raise up to $20.4 million in gross proceeds.
ONS-5010/LYTENAVA has received regulatory approval in the European Union and the United Kingdom for wet AMD and the company plans to launch it commercially in Europe in the first half of 2025.
Currently, OTLK is trading at $2.07 down by 10.00%.
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