Outlook Therapeutics completes FDA dispute resolution meeting for LYTENAVA™ (bevacizumab-vikg) in wet AMD, with formal regulatory feedback expected in May 2026.
Written By: Pharmacally Medical News Desk
Outlook Therapeutics has completed a Federal Dispute Resolution (FDR) meeting with the U.S. Food and Drug Administration as it continues efforts to clarify the regulatory pathway for its investigational ophthalmic therapy, ONS-5010/LYTENAVA™ (bevacizumab-vikg).
The meeting, held with the FDA’s Office of New Drugs, follows earlier discussions with the Division of Ophthalmology and the Office of Specialty Medicine. These engagements are part of the company’s response to a Complete Response Letter (CRL) issued on December 30, 2025, regarding its Biologics License Application (BLA) for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Outlook Therapeutics stated that the FDR meeting aimed to achieve alignment with the agency on regulatory expectations and next steps. The company expects to receive formal written feedback from the FDA in May 2026 and plans to provide an update thereafter.
Chief Executive Officer Bob Jahr indicated that the discussion with the FDA was constructive and represents progress in refining the company’s regulatory strategy. He emphasized the company’s intention to continue working closely with the agency to establish a clear path toward potential U.S. approval.
Product Background
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab designed specifically for intravitreal use in retinal diseases. The therapy targets vascular endothelial growth factor (VEGF), a key driver of abnormal blood vessel growth and leakage in wet AMD.
Bevacizumab-vikg is a recombinant humanized monoclonal antibody that binds to all isoforms of VEGF. By blocking VEGF from interacting with its receptors (VEGFR-1 and VEGFR-2) on endothelial cells, the drug reduces abnormal vessel formation, vascular permeability, and retinal damage following intravitreal injection.
Regulatory Status
While investigational in the United States, LYTENAVA™ has already received centralized Marketing Authorization in the European Union from the European Commission and approval in the United Kingdom from the Medicines and Healthcare products Regulatory Agency for the treatment of wet AMD. Commercial availability in certain EU member states remains subject to pricing and reimbursement approvals.
The outcome of the FDA’s forthcoming feedback will be a key determinant in defining the next phase of regulatory progress for the therapy in the U.S. market.
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