By Robb M. Stewart
Outlook Therapeutics will resubmit a biologics license application for its ophthalmic formulation of bevacizumab early next year after the second of two clinical trials missed a key target.
The biopharmaceutical company said the trial of ONS-5010 to treat wet age-related macular degeneration didn't meet the pre-specified non-inferiority endpoint at week eight that was set out in a special protocol assessment the U.S. Food and Drug Administration.
News of the result weighed heavily on Outlook's shares, which sank 80% in premarket trading. The shares had ended Tuesday at $4.89, down 38% so far in 2024.
Wet age-related macular degeneration is an eye condition that occurs when abnormal blood vessels start to grow beneath the retina.
Outlook, which received regulatory approval earlier this year in the European Union and the U.K. for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration, said preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity. It also showed a continued favorable safety profile for ONS-5010.
Analysis of the data is ongoing as month-three data from the study is being collected, which is expected to be available in January. Outlook said that when it received the full month-three efficacy and safety results it plans to resubmit the license application for ONS-5010 in the first quarter of 2025.
Outlook said it remains confident that ONS-5010, marketed as Lytenava in the EU, is an important therapy for the treatment of wet age-related macular degeneration in place of off-label repackaged bevacizumab that hasn't received regulatory approval for use in ophthalmology.
The company said its plans for a potential 2025 launch in the U.K. and Germany are ongoing, where Lytenava has European Commission and U.K. MHRA Marketing Authorization for the treatment of wet age-related macular degeneration.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
November 27, 2024 07:37 ET (12:37 GMT)
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