On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™ for wet AMD.
The acceptance follows the resubmission of the BLA earlier this month after the company’s Type A meeting with the FDA in September 2025 to address the Complete Response Letter (CRL) issued in August 2025. According to Outlook, the FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 2025 action letter, which results in a 60-day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 31 December 2025.
Outlook had previously 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.
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 in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.