Dec 31 (Reuters) – Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, marking another setback in the company’s long-running effort to bring the treatment to market.
The company was testing the drug, Lytenava, for the treatment of wet age-related macular degeneration, a chronic eye disorder that causes blurred vision or a blind spot in the patient’s visual field. The disease is a leading cause of blindness among the elderly.
The U.S. Food and Drug Administration had initially declined to approve the drug in 2023, in part due to manufacturing issues observed during pre-approval inspections. A year earlier, the company withdrew its application following an FDA request for additional information.
The regulator again declined to approve the eye drug in August 2025, citing a lack of substantial evidence of effectiveness, and recommended the company submit additional data to support the application.
Outlook said on Wednesday the FDA concluded that additional data provided with the resubmission did not change its prior view. While one adequate and well-controlled study demonstrated efficacy, the agency again recommended confirmatory evidence of efficacy to support approval.
Shares of the company were halted in extended trading.
(Reporting by Sriparna Roy and Puyaan Singh in Bengaluru; Editing by Shreya Biswas and Shilpi Majumdar)
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