Drugs

FDA Grants Outlook Therapeutics’ Dispute Resolution Request

FDA has accepted an Outlook Therapeutics formal dispute resolution request (FDRR) regarding the agency’s prior rejection of eye disease therapy ONS-5010/Lytenava (bevacizumab-vikg), setting up a high-stakes meeting later this month. The dispute stems from a December complete response letter (CRL) on the company’s BLA that was seeking approval of the drug for treating neovascular age-related macular degeneration (wet AMD).

The company initiated the request following a Type A meeting with the agency last month. “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.

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.

The product is already authorized in Europe, having received approval from both the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency, and has launched commercially in select markets, including Germany, Austria, and the United Kingdom.

Outlook says it will continue engaging with the FDA throughout the dispute process and provide updates as developments occur.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome