Why did the FDA reject Outlook Therapeutics' Lytenava?

The FDA declined approval for Lytenava, citing a lack of substantial evidence of effectiveness.

What eye disease is Lytenava intended to treat?

Lytenava was being developed to treat wet age-related macular degeneration, a common cause of vision loss in older adults.

Has Lytenava been approved before by the FDA?

No, the FDA has declined to approve Lytenava on multiple occasions, most recently in August 2025.

Home / Health / FDA Rejects Eye Drug Again, Citing Lack of Proof

FDA Rejects Eye Drug Again, Citing Lack of Proof

1 Jan

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Summary

FDA declined approval for Lytenava for wet age-related macular degeneration.
This marks the second FDA rejection after previous setbacks.
The regulator cited a lack of substantial evidence of effectiveness.

FDA Rejects Eye Drug Again, Citing Lack of Proof

The U.S. Food and Drug Administration (FDA) has once again declined to approve Outlook Therapeutics' drug, Lytenava, for treating wet age-related macular degeneration. This chronic eye disorder significantly impacts vision, particularly in the elderly population. The company has faced multiple hurdles in its pursuit of market approval for this treatment.

The FDA's decision, communicated on Wednesday, highlights a continuing concern regarding the drug's efficacy. Previously, in August 2025, the regulator had also declined approval, requesting additional data. This followed an earlier instance in 2023 where manufacturing issues were a primary concern, and a withdrawal in the year prior due to a request for more information.

Outlook Therapeutics stated that the additional data submitted did not alter the FDA's previous assessment. While one study showed efficacy, the agency reiterated the need for confirmatory evidence. Shares of the company experienced a halt in extended trading following the announcement, underscoring the significant impact of this regulatory outcome.