Outlook Therapeutics Holds FDA Type A Meeting on ONS-5010 Complete Response Letter

Outlook Therapeutics, Inc. conducted a Type A meeting with the U.S. Food and Drug Administration on March 5, 2026 to discuss the December 30, 2025 Complete Response Letter for the Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg). The Type A meeting was conducted to clarify the outstanding issue identified in the CRL regarding substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval.

The Company expects to continue engaging in discussions with the FDA to further clarify the Agency's views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010/LYTENAVA™ toward potential U.S. approval.

The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness.

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. NORSE EIGHT, along with other information submitted to the BLA, demonstrated confirmatory evidence of efficacy and safety of ONS-5010 supporting the successful NORSE TWO trial, including functional and pharmacodynamic evidence consistent with the anti-VEGF mechanism of action. ONS-5010 also demonstrated a favorable safety profile, with no safety concerns identified by the FDA.

If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. The product candidate is supported by a fully domestic, end-to-end U.S. manufacturing supply chain.

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet age-related macular degeneration. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency in the UK for the treatment of wet AMD.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor and neutralizes VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $23.1 million, or $0.38 per basic and diluted share. This compares with net income attributable to common stockholders of $17.4 million, or $0.72 per basic and diluted share for the same period last year. As of December 31, 2025, Outlook Therapeutics had cash and cash equivalents of $8.7 million, which does not include $2.4 million of net proceeds from sales under its at-the-market offering program after December 31, 2025.

Unit sales of LYTENAVA in Europe more than doubled in the quarter ended December 31, 2025, as compared to the previous three months. Revenue in the fiscal quarter ended December 31, 2025 was negatively impacted by an increase in the returns reserve for estimated product returns from the UK distributor resulting from short dated product used for the initial shipments into the distribution channel in June 2025 to support the launch of LYTENAVA in Europe. No further adjustments for these batches are anticipated for the remainder of fiscal year 2026.