Outlook Therapeutics submitted a formal dispute resolution request to the FDA for ONS-5010/LYTENAVA after a CRL, citing NORSE trial data supporting efficacy and safety in wet AMD.
Written By: Pharmacally Medical News Desk
Outlook Therapeutics, Inc. announced that it has submitted a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration following a recent Type A meeting related to the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) of ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (wet AMD). The FDA has accepted the request and granted a meeting with the deciding official scheduled for April 2026.
Regulatory Engagement Following CRL
After receiving the CRL in December 2025, Outlook Therapeutics engaged in multiple interactions with the FDA, including a formal Type A meeting held on March 2, 2026. The discussions led to the submission of the FDRR and the newly scheduled meeting aimed at resolving outstanding regulatory issues.
The company’s submission includes a comprehensive presentation of clinical efficacy, functional outcomes, pharmacodynamic findings, and safety data. Outlook Therapeutics stated that these data collectively support the benefit-risk profile of ONS-5010/LYTENAVA for the treatment of wet AMD.
Executive Commentary
Chief Executive Officer Bob Jahr said the company remains confident that safety and efficacy data from the NORSE TWO and NORSE EIGHT studies provide sufficient evidence to support approval and enable access to an FDA-approved bevacizumab option for patients with neovascular AMD.
Clinical Evidence Supporting the BLA
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, meeting both primary and key secondary endpoints. Additional supportive evidence from NORSE EIGHT and other datasets submitted in the BLA further reinforce the therapy’s efficacy and safety profile, consistent with its anti-VEGF mechanism of action. The company noted that no safety concerns were raised by the FDA.
If approved, ONS-5010/LYTENAVA would become the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, approved labeling, and a structured pharmacovigilance program. The product candidate is also supported by a fully domestic, end-to-end U.S. manufacturing supply chain.
About ONS-5010 / LYTENAVA (Bevacizumab-vikg)
ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab manufactured in the United States for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) has already received centralized marketing authorization from the European Commission and approval from the Medicines and Healthcare products Regulatory Agency for wet AMD in Europe and the United Kingdom, although pricing and reimbursement approvals are required in certain EU member states prior to commercialization.
In the United States, bevacizumab-vikg remains investigational. The recombinant humanized monoclonal antibody selectively binds all isoforms of vascular endothelial growth factor (VEGF), blocking interaction with VEGFR-1 and VEGFR-2 receptors on endothelial cells. Following intravitreal injection, VEGF inhibition reduces endothelial proliferation, vascular leakage, and abnormal blood vessel formation in the retina.
Reference
Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA, 07 April 2026, Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA – Outlook Therapeutics, Inc.