On 24 July 2026, Outlook Therapeutics announced that the FDA has approved ONS-5010/Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD/wet AMD). Outlook expects Lytenava™ will be available to eligible patients in the US before the end of 2026.
Lytenava™ is the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of nAMD. Outlook Therapeutics considers that Lytenava will have 12 years of Reference Product Exclusivity under the US BPCIA.
Since Outlook’s initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA 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. The FDA accepted Outlook’s resubmitted Biologics License Application for Lytenava™ in June 2026 with a Prescription Drug User Fee Act target date of 29 July 2026.
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.