US FDA declines to approve Outlook Therapeutics' eye disease drug

[August 30, 2023]  (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 71% at $0.40 in premarket trading.

Although the trial for the drug met the goals of safety and efficacy, the health regulator cited the need for further confirmatory clinical evidence, Outlook Therapeutics said.

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.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The development marks the latest roadblock for the drug to enter the market, after Outlook Therapeutics last year withdrew its application after the FDA requested for additional information.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta)

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