FDA Policy/General

Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava

Outlook Therapeutics says it has completed a formal dispute resolution meeting with FDA as part of the company’s push to revive its approval prospects for ONS-5010, also known as LYTENAVA (bevacizumab-vikg), following a regulatory setback late last year. The meeting with CDER’s Office of New Drugs marks the latest step in the company’s effort to align with regulators after receiving a complete response letter (CRL) on 12/30/2025 for its BLA that sought the therapy’s approval in neovascular age-related macular degeneration (wet AMD).

Outlook says the meeting builds on prior discussions with the agency, including a Type A meeting with the Division of Ophthalmology, as it works to clarify the appropriate regulatory pathway for the therapy. The company expects formal written feedback from FDA in May, which could shape next steps for the program.

Outlook expects to provide an update once it receives FDA’s formal response.

“We look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for Lytenava demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval,” said chief executive officer Bob Jahr earlier this month.

Outlook maintains that its submission includes comprehensive clinical, functional, pharmacodynamic, and safety data supporting the drug’s benefit-risk profile. The company emphasizes that the Phase 3 NORSE TWO trial met its primary and key secondary endpoints, showing statistically significant improvements in visual acuity, with additional supportive data from the NORSE EIGHT study.

The company has been rejected three times by FDA reviewers. An 8/2025 CRL cited insufficient evidence of effectiveness. The agency said it could not approve the application in its current form because the pivotal NORSE EIGHT trial failed to meet its primary efficacy endpoint, according to the company. While FDA acknowledged that the earlier NORSE TWO study did demonstrate effectiveness, regulators recommended in the letter that the company provide confirmatory evidence before the drug could be considered for approval

In 8/2023, FDA issued the original BLA a complete response letter that cited several chemistry, manufacturing and control (CMC) issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence, according to the company.

Lytenava is an ophthalmic formulation of bevacizumab, an anti-VEGF monoclonal antibody designed to inhibit abnormal blood vessel growth and leakage in the retina. While bevacizumab is widely used off-label in ophthalmology, no FDA-approved ophthalmic formulation currently exists, the company says.

If approved, the therapy would become the first FDA-approved ophthalmic version of bevacizumab, offering standardized manufacturing, formal labeling, and enhanced pharmacovigilance, according to the company.

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