Shares of Outlook Therapeutics Inc. (OTLK), a biopharmaceutical company specializing in ophthalmic treatments, are down over 70% in premarket trading, following mixed results from its NORSE EIGHT trial.
NORSE EIGHT is the second of the two-phase III trials evaluating ONS-5010 in wet age-related macular degeneration (wet AMD) patients.
According to the study findings, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA. However, there was an improvement in vision, and signs of biological activity in patients treated with ONS-5010.
The 3-month data from the NORSE EIGHT trial is being collected and is expected to be available in January 2025.
The company plans to resubmit its Biologics License Application (BLA) for ONS-5010 in the first quarter of 2025, pending the final analysis.
The FDA declined to approve ONS-5010 in August 2023, due to several Chemistry, Manufacturing, and Controls (CMC) issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
ONS-5010 received European Commission Marketing Authorization for the treatment of Wet AMD in May 2024 and UK MHRA Marketing Authorization in July 2024, under the brand name LYTENAVA. The commercial launch of LYTENAVA in the EU and UK is anticipated in the first half of the calendar year 2025.
OTLK closed Tuesday's trading at $4.89, down 0.81%. In premarket trading today, the stock is down by 78.94% at $1.03.
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