2026-02-11, 6:49:10 a.m.
ISELIN, N.J. — February 11, 2026 — Leads & Copy — Outlook Therapeutics, Inc. (Nasdaq: OTLK) 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, dated December 30, 2025, cited a single deficiency based on a purported lack of substantial evidence of effectiveness, recommending 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.
According to Outlook Therapeutics, the issuance of the CRL was unexpected, based on prior discussions with the FDA in September 2025. The company understood that it had aligned with the FDA on the requirements for resubmission of the BLA.
Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL.
Bob Jahr, Chief Executive Officer of Outlook Therapeutics, said the company 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. Jahr added that the company is committed to working constructively with the FDA to resolve these issues and to bringing this important therapy to patients with wet AMD in the United States.
The BLA for ONS-5010 is supported by clinically meaningful data, including results from 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. NORSE TWO met its primary endpoint – patients gaining three lines (15 letters) of visual acuity – and a key secondary endpoint of mean change from baseline in visual acuity.
Additional secondary endpoints, including gains of one line, two lines, and preservation of vision (loss of fewer than three lines), further reinforce the robustness and consistency of the treatment effect.
At the FDA’s request, Outlook Therapeutics also conducted NORSE EIGHT, a second adequate and well-controlled Phase 3 study. While NORSE EIGHT did not meet its primary endpoint at 8 weeks, the study demonstrated a positive trajectory consistent with NORSE TWO through 12 weeks of treatment and provided important functional and mechanistic/pharmacodynamic evidence of efficacy. Specifically, NORSE EIGHT 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.
In addition to NORSE TWO and NORSE EIGHT, Outlook Therapeutics submitted a comprehensive package of confirmatory evidence, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition and natural history data showing that the observed improvements with ONS-5010 represent a clear departure from the expected progression of untreated wet AMD. Outlook Therapeutics believes the resubmitted BLA fully satisfied the substantial evidence standard for demonstrating effectiveness and intends to continue to work with the FDA on a path forward for resolving the FDA’s request for additional confirmatory evidence.
ONS-5010 also demonstrated a favorable safety profile, with ocular adverse reactions consistent with both the control arm (ranibizumab) and with intravitreal injections generally and the FDA has never expressed any safety concerns with ONS-5010. 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.
ONS-5010/LYTENAVA™ (bevacizumab-vikg) is supported by a fully domestic, end-to-end U.S. manufacturing supply chain.
LYTENAVA™ (bevacizumab gamma) was granted Marketing Authorization by the European Commission in the EU and Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In June 2025, LYTENAVA™ (bevacizumab gamma) became commercially available in Germany and the UK for the treatment of wet AMD.
In addition to current plans to expand its commercial presence in select countries in Europe, Outlook Therapeutics continues to speak with and explore collaborations with potential commercial and distribution partners in additional European countries, as well as outside of Europe. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK.
Outlook Therapeutics is 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. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.
ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Source: Outlook Therapeutics, Inc.
