Outlook Therapeutics ( OTLK ) announced on Monday that it has submitted a formal dispute resolution request (FDRR) to the U.S. Food and Drug Administration (FDA) regarding its ONS-5010/LYTENAVA.

The update comes after receiving a Complete Response Letter (CRL) in December 2025 for its Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration.

The FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026.

Clinical Data Highlights

ONS-5010/LYTENAVA demonstrated clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO randomized, double-masked, active-controlled Phase 3 trial, which met its primary and key secondary endpoints.

Additional evidence from NORSE EIGHT and other data submitted in the BLA further supports the efficacy and safety profile of ONS-5010, consistent with its anti-VEGF mechanism of action.

The FDA has raised no safety concerns.

FDA Review History

In August 2025, the FDA issued a CRL to ONS-5010 resubmission. The CRL included only one deficiency for a lack of substantial evidence of effectiveness.

In August 2023, Outlook Therapeutics ( OTLK ) received a complete response letter from the FDA regarding ONS-5010.

The FDA noted that the additional mechanistic and natural history data provided in the BLA resubmission do not alter the previous review conclusion.

Outlook Therapeutics Challenges FDA’s Decision

In the U.S., ONS-5010/LYTENAVA remains investigational, but its potential approval would mark it as the first FDA-approved ophthalmic bevacizumab formulation.

The product has already gained approval in Europe. Outlook Therapeutics ( OTLK ) emphasizes the robust pharmacovigilance and domestic U.S. manufacturing supply chain supporting ONS-5010/LYTENAVA.

This positions the company to meet regulatory standards and expand its market presence.

OTLK Price Action: Outlook Therapeutics ( OTLK ) shares were up 4.64% at $0.20 at the time of publication on Tuesday. The stock is trading near its 52-week low of $0.16, according to Benzinga Pro data.

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