On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for ONS-5010/Lytenava™ (bevacizumab-vikg) for wet AMD. The FDR process is an appeal mechanism that permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision.
In December 2025, the FDA issued a Complete Response Letter (CRL) for the second resubmission of ONS-5010/Lytenava™, recommending that additional confirmatory evidence be provided to support Outlook’s application, though it did not clarify what type of evidence would be acceptable. Outlook subsequently attended a Type A meeting with the FDA in March 2026 to discuss the CRL and then submitted its Formal Dispute Resolution Request in April 2026.
In its appeal decision, the FDA concluded that substantial evidence of effectiveness has been established for Lytenava™ for the treatment of wet AMD, despite the earlier CRL. The decision directs the FDA’s Division of Ophthalmology (Division) and Office of Specialty Medicine (OSM) to work with Outlook Therapeutics to reach agreement on final labelling.
Outlook Therapeutics expects to resubmit the BLA for ONS-5010/Lytenava™ in June 2026. If approved, ONS-5010/Lytenava™ would be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA.
Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024. It was launched in the UK and Germany in June 2025.
Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.