Outlook Therapeutics Submits Type A Meeting Request to FDA After Receiving Complete Response Letter

Biopharmaceutical company seeks to resolve deficiency identified by FDA regarding its BLA for wet AMD treatment

Published on Feb. 12, 2026

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Outlook Therapeutics, Inc., a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) regarding the company's Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA.

Why it matters

The availability of an FDA-approved bevacizumab product for wet AMD would provide patients and physicians with a consistent, high-quality, commercially manufactured option supported by FDA-approved labeling, standardized manufacturing, and robust pharmacovigilance. Outlook Therapeutics remains confident in the strength of the clinical evidence supporting ONS-5010 and is committed to working constructively with the FDA to resolve these issues and bring this important therapy to patients with wet AMD in the United States.

The details

Outlook Therapeutics conducted NORSE TWO, a single adequate and well-controlled Phase 3 trial that demonstrated statistically significant and clinically relevant improvements in visual acuity at 12 months. The company also conducted NORSE EIGHT, a second adequate and well-controlled Phase 3 study, which while not meeting its primary endpoint at 8 weeks, showed consistent gains in best-corrected visual acuity across all measured timepoints, low variability, and results aligned with the established anti-VEGF mechanism of action. Outlook Therapeutics also submitted a comprehensive package of confirmatory evidence, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition and natural history data.

  • Outlook Therapeutics received a Complete Response Letter from the FDA on December 30, 2025.
  • Outlook Therapeutics conducted informal meetings with the FDA prior to submitting the Type A meeting request.

The players

Outlook Therapeutics, Inc.

A biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases.

U.S. Food and Drug Administration (FDA)

The regulatory agency responsible for reviewing and approving Outlook Therapeutics' Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration.

Bob Jahr

Chief Executive Officer of Outlook Therapeutics.

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What they’re saying

“Outlook Therapeutics remains confident in the strength of the clinical evidence supporting ONS-5010 and firmly believes the totality of data meets the FDA's substantial evidence standard.”

— Bob Jahr, Chief Executive Officer

What’s next

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