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, dealing another blow in the company’s prolonged push to bring the treatment to market and sending its shares tumbling nearly 70% after the bell. The company was testing the drug, […]
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US FDA declines to approve Outlook’s eye disease drug for second time in 2025
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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, dealing another blow in the company’s prolonged push to bring the treatment to market and sending its shares tumbling nearly 70% after the bell.
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, also called bevacizumab, in 2023, in part due to manufacturing issues observed during pre-approval inspections.
It again declined to approve the 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, and it again recommended confirmatory evidence of efficacy to support approval.
The FDA has not indicated what type of confirmatory evidence would be acceptable for Lytenava, which is approved in the European Union and the UK, the company said.
In a key trial conducted by Outlook to address some of the FDA’s previous concerns, the drug failed to match Roche’s Lucentis at eight weeks.
The company had been counting on the drug’s approval as the first eye disease-specific adaptation of bevacizumab, sold by Roche under the brand name of Avastin to treat cancer, but also used off-label to treat eye diseases.
Lytenava belongs to a class of drugs known as anti-vascular endothelial growth factor, the current standard-of-care for wet AMD, which works against a protein believed to play a key role in the disease.
These drugs are designed to block or regulate the formation and growth of blood vessels.
Regeneron’s Eylea and Roche’s Vabysmo and Lucentis are some of the approved drugs to treat wet AMD.
(Reporting by Sriparna Roy and Puyaan Singh in Bengaluru; Editing by Shreya Biswas and Shilpi Majumdar)