On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for review by the FDA. The Prescription Drug User Fee Act (PDUFA) target date is 29 July 2026.
If approved, ONS-5010/Lytenava™ will be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA to treat wet AMD. Outlook Therapeutics has commenced pre-launch activities in anticipation of the pending approval.
Since its initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA has issued three Complete Response Letters (CRL) to Outlook (in August 2023, August 2025 and December 2025). After a Type A meeting in March 2026, Outlook requested a Formal Dispute Resolution (FDR) process. In May 2026, the FDA granted the appeal, concluding that substantial evidence of effectiveness had been established for Lytenava™ for the treatment of wet AMD, despite the third CRL to the contrary.
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.