On 5 March 2026, Outlook Therapeutics provided an update on ONS-5010/Lytenava™, ophthalmic biosimilar to Roche/Genentech’s Avastin® (bevacizumab-vikg), following a Type A meeting with the U.S. Food and Drug Administration (FDA).
The Type A meeting was held to clarify an issue regarding substantial evidence of effectiveness identified in the third Complete Response Letter (CRL) issued in December 2025 for the ONS-5010/Lytenava™ Biologics License Application (BLA). The meeting was also used to discuss potential regulatory approval steps. Outlook Therapeutics stated it will continue to engage with the FDA to further clarify the FDA’s view on confirmatory evidence and the regulatory path forward.
The March 2026 Type A meeting is the second Type A meeting Outlook Therapeutics has held with the FDA for its ophthalmic bevacizumab biosimilar. The first Type A meeting occurred in September 2025 to address the second CRL issued in August 2025. The CRL recommended that Outlook Therapeutics submit additional confirmatory efficacy data to support its application.
Outlook Therapeutics had already resubmitted its BLA to the FDA in February 2025, following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials. A second CRL (August 2025) recommended Outlook submit additional efficacy data to support its application for ONS-5010. Outlook Therapeutics resubmitted its BLA to the FDA in November 2025, in order to address the issues in the August 2025 CRL.
Lytenava™ received marketing authorisation in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025. The Scottish Medicines Consortium also accepted Lytenava™ for use within NHS Scotland in June 2025.
Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025