Outlook Therapeutics (NASDAQ:OTLK), a biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab, announced on April 7, 2026, that the U.S. Food and Drug Administration (FDA) has accepted its Formal Dispute Resolution Request (FDRR) regarding ONS-5010/LYTENAVA™ (bevacizumab-vikg).
The agency has granted a meeting with a high-level deciding official, scheduled to take place within the month of April 2026.
This administrative appeal follows a series of regulatory hurdles, including a Complete Response Letter (CRL) issued by the FDA on December 30, 2025, and a subsequent Type A meeting held on March 2, 2026.
The FDRR process is a formal pathway used by sponsors to appeal scientific or procedural disputes with the FDA that cannot be resolved at the division level.
Outlook is seeking to overturn the agency's previous determination and gain a path toward approval for ONS-5010 as a treatment for wet age-related macular degeneration (wet AMD).
In its filing, Outlook cited a robust clinical dataset from its Phase 3 NORSE TWO and NORSE EIGHT trials, which the company maintains provide substantial evidence of the drug's efficacy and safety.
Notably, Outlook reported that the FDA has raised no specific safety concerns regarding the product.
The company also emphasized its readiness for commercialization, highlighting a fully established U.S.-based end-to-end manufacturing supply chain.
The wet AMD market currently relies heavily on the "off-label" use of compounded intravenous bevacizumab.
Outlook’s ONS-5010 aims to replace these unapproved compounded versions with a finalized, sterile, and potency-verified ophthalmic formulation, potentially reducing the risk of ocular infections and inflammatory responses for patients.