Outlook Therapeutics Files FDA Dispute Request To Advance ONS-5010 Approval For Age-Related Macular Degeneration

Outlook Therapeutics, Inc. has submitted a formal dispute resolution request (FDRR) to the U.S. Food and Drug Administration following a Complete Response Letter (CRL) issued in December 2025 for its Biologics License Application (BLA) for ONS-5010/LYTENAVA™. The FDA has accepted the request and scheduled a meeting with a deciding official in April 2026, marking the next step in the regulatory review process.

The company has remained actively engaged with the FDA since receiving the CRL, including a Type A meeting held in March 2026. The FDRR submission includes a comprehensive set of clinical, pharmacodynamic, and safety data, which Outlook Therapeutics believes supports the efficacy and safety of ONS-5010/LYTENAVA™ for treating neovascular age-related macular degeneration (AMD).

“We look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for LYTENAVA demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval and bring a much-needed FDA approved option for patients,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

Clinical evidence from the Phase 3 NORSE TWO trial demonstrated statistically significant improvements in visual acuity, meeting both primary and key secondary endpoints. Additional supporting data from other studies, including NORSE EIGHT, further reinforce the therapy’s profile, with no safety concerns identified by the FDA to date. The drug works through an anti-VEGF mechanism, a well-established approach in retinal disease treatment.

If approved, ONS-5010/LYTENAVA™ could become the first FDA-approved ophthalmic formulation of bevacizumab with standardized manufacturing and labeling. The product is also supported by a fully domestic U.S.-based manufacturing supply chain, positioning it as a potentially reliable and scalable treatment option. Outlook Therapeutics has stated it will continue collaborating with the FDA throughout the resolution process and provide updates as developments occur.