Outlook Therapeutics (OTLK) said Wednesday preliminary results from the second of two clinical trials evaluating its experimental drug, ONS-5010, an opthalmic formulation of bevacizumab in wet age-related macular degeneration patients, did not meet the pre-specified non-inferiority endpoint in the special protocol assessment with the US Food and Drug Administration.
Shares of the company fell more than 82% in recent Wednesday premarket activity.
The company said its drug candidate, however, showed an improvement in vision and the presence of biologic activity, and a favorable safety profile.
It added that the final data analysis is expected by January 2025, and it plans to resubmit its Biologics License Application in Q1.
The drug developer is also preparing for a potential 2025 launch in the UK and Germany of Lytenav, the European brand of ONS-5010, where it has already been granted Marketing Authorization.
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