FDA CRL - Outlook Therapeutics, Inc.

Outlook Therapeutics, Inc. has received a Complete Response Letter from the FDA regarding its Biologics License Application for bevacizumab-vikg injection, intended for the treatment of wet age-related macular degeneration (wet-AMD). The FDA determined that the application cannot be approved in its current form because the company failed to provide substantial evidence of the drug's effectiveness. Specifically, while the NORSE TWO clinical trial was successful, the NORSE EIGHT trial failed to meet its primary endpoint regarding improvements in patient vision compared to the standard treatment. The FDA concluded that the additional data provided did not offer the necessary confirmatory evidence to support the proposed monthly dosing regimen.

Under the regulatory framework of 21 CFR 314.126 and 601.3, the FDA requires Outlook Therapeutics to submit additional clinical evidence demonstrating efficacy. Furthermore, the company must provide a comprehensive safety update as per 21 CFR 314.50, which must include new data from all clinical trials, detailed reports on adverse events, and a summary of worldwide safety experience. The company has one year to address these deficiencies in a formal resubmission or request an extension. The product may not be legally marketed until the FDA issues a formal approval following a complete review of the new evidence.