The U.S. Food and Drug Administration (FDA) has once again declined to approve Outlook Therapeutics’ drug for a type of eye disease, marking a second rejection in 2025 and prompting a sharp drop in the company’s shares.

The drug, Lytenava, was being developed to treat wet age-related macular degeneration (AMD), a chronic eye condition that can cause blurred vision or blind spots and is a leading cause of vision loss among older adults.

The FDA had previously rejected the drug in 2023, partly due to manufacturing issues identified during pre-approval inspections. In its latest decision in August 2025, the agency cited insufficient evidence of the drug’s effectiveness and recommended that the company provide additional data to support approval.

Outlook stated that the additional data submitted did not change the FDA’s assessment, which again emphasized the need for confirmatory evidence demonstrating the drug’s efficacy. The agency has not specified what type of evidence would meet this requirement. Lytenava is, however, approved for use in the European Union and the United Kingdom.

In clinical trials aimed at addressing previous FDA concerns, Lytenava did not perform as well as Roche’s Lucentis at the eight-week mark. The company had hoped to position Lytenava as the first eye disease-specific version of bevacizumab, a drug sold under the brand name Avastin for cancer treatment that is also used off-label for certain eye conditions.

Lytenava is part of a class of medications known as anti-vascular endothelial growth factor (anti-VEGF) drugs, which are the current standard of care for wet AMD and work by inhibiting the growth of abnormal blood vessels in the eye. Other approved treatments for the condition include Regeneron’s Eylea and Roche’s Lucentis and Vabysmo.