Outlook Therapeutics Faces Third FDA Rejection for Key Eye Drug

Outlook Therapeutics has encountered another significant regulatory obstacle in the United States. For a third time, the U.S. Food and Drug Administration (FDA) has declined to approve the company’s ophthalmology drug candidate, ONS-5010, also known as LYTENAVA™. This decision comes despite the firm submitting additional data in an effort to address the agency's concerns, with regulators now calling for more confirmatory evidence before granting final approval.

• A third Complete Response Letter (CRL) from the FDA prevents U.S. commercialization.
• The agency is requesting additional confirmatory efficacy data.
• A European and United Kingdom launch is scheduled for the second quarter of 2025.

While progress in the U.S. remains stalled, Outlook Therapeutics has secured regulatory wins elsewhere. During 2024, marketing authorization for the treatment of wet age-related macular degeneration (AMD) was granted by both the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The commercial rollout across Europe and Britain is currently planned for Q2 2025.

To support this international launch and prepare for a potential future U.S. introduction, the company has entered a strategic partnership with the healthcare services provider Cencora. This agreement is designed to manage logistics, distribution, and pharmacovigilance, ensuring access to specialists and patients upon receiving the necessary regulatory clearances.

The Persistent Challenge of FDA Approval

The latest communication from the FDA states that the application in its present form cannot be approved. A notable point of contention is that, while the agency acknowledged recently submitted mechanistic data supported the drug's efficacy, it maintained its position that further confirmatory proof is required. The specific nature of the additional evidence needed was not detailed by regulators.

Should investors sell immediately? Or is it worth buying Outlook Therapeutics?

This development represents the latest in a series of setbacks for Outlook Therapeutics' efforts to bring its product to the American market. Previous attempts at approval were unsuccessful in August 2023 and again in August 2025, with the FDA citing varying issues ranging from manufacturing concerns to unmet endpoints in clinical trials. Company leadership expressed disappointment but reaffirmed its commitment to ultimately launching ONS-5010 as the first FDA-approved ophthalmic formulation of bevacizumab in the United States.

Management Strengthening and Upcoming Financial Calendar

Amid its ongoing regulatory efforts, Outlook Therapeutics has bolstered its executive team. In early January, Laura Cantrell was appointed to the role of Vice President of Corporate Strategy and Business Development, a move intended to advance the company's strategic initiatives.

Investor attention now turns to forthcoming financial disclosures. The biopharmaceutical firm is expected to release its next quarterly earnings report between February 13 and 17, 2026. The future of its U.S. ambitions hinges critically on whether management can persuade the FDA based on existing data in upcoming discussions or promptly generate the supplementary information now being demanded.