By Colin Kellaher

Shares of Outlook Therapeutics plunged in premarket trading after the Food and Drug Administration once again rejected the biopharmaceutical company's proposed ONS-5010 treatment for the eye condition wet age-related macular degeneration, or wet AMD.

Outlook on Thursday said the FDA has issued another so-called complete response letter, indicating the agency won't approve the Iselin, N.J., company's application in its current form.

Outlook shares, which closed Wednesday at $2.375, were recently down 71% to 70 cents in premarket trading.

Outlook, which plans to market ONS-5010, said the FDA cited a lack of substantial evidence of effectiveness and recommended that the company submit confirmatory evidence of efficacy to support the application.

The FDA in August 2023 turned away Outlook's initial application for ONS-5010, citing several chemistry, manufacturing and controls issues and a need for further confirmatory clinical evidence. Outlook resubmitted its application in February, and the FDA accepted it in April with a target action date of Aug. 27.

Outlook said it plans to meet with the FDA to receive additional clarity on the agency's requirements, adding that it will continue its efforts to expand into more markets in Europe.

The company earlier this year won European Commission and U.K. regulatory approval for ONS-5010, marketed as Lytenava, for the treatment of wet AMD, an eye condition that causes blurred vision or reduced central vision.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 28, 2025 07:22 ET (11:22 GMT)

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