(Reuters) -Outlook Therapeutics said on Wednesday the U.S. Food and Drug Administration declined to approve its experimental eye disease drug, in part due to manufacturing issues observed during pre-approval inspections.
The company's shares were down about 78% at 30 cents in premarket trading.
The health regulator's decision marks the latest roadblock for the drug to enter the market, after Outlook Therapeutics last year withdrew its application following an FDA request for additional information.
Outlook Therapeutics said on Wednesday that although the trial for the drug met the goals of safety and efficacy, the FDA cited the need for further confirmatory clinical evidence.
The drug ONS-5010 is under development as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.
Wet AMD is a chronic eye disorder that causes blurred vision or a blind spot in the patient's visual field, and is the leading cause of blindness among the elderly.
Outlook Therapeutics had been pinning its hopes on the approval of the drug as the first eye-disease focused version of Roche's cancer drug Avastin.
Outlook Therapeutics will request a meeting with the FDA to address the issues. The European Medicines Agency is set to begin its review process for the drug, with a decision date expected early next year.
The company's application to the FDA was based on a late-stage trial, which showed the drug improved vision in 41.7% patients who were able to read at least 3 lines or 15 letters, when tested in their ability to distinguish shapes and the details.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta)
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