On 7 April 2026, Outlook Therapeutics announced that it has submitted a formal dispute resolution request (FDRR) to the FDA following a Type A meeting in March 2026 in relation to its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.
The FDRR is an appeal process which 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. The FDA has accepted Outlook’s FDRR and has scheduled a meeting with the deciding official in April 2026.
The March 2026 Type A meeting was held to clarify an issue identified in a Complete Response Letter issued by the FDA in December 2025 regarding the second resubmission of Outlook’s Biologics Licence Application (BLA) for ONS-5010/Lytenava™. In the CRL, the FDA had recommended that additional confirmatory evidence be provided to support the application, though it did not clarify what type of evidence would be acceptable.
In its April 2026 press release, Outlook Therapeutics reiterated that it remains committed to its position “that data on safety and efficacy for Lytenava™ demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval”.
Outlook Therapeutics received a first CRL from the FDA for Lytenava™ in August 2023 and subsequently submitted a Special Protocol Assessment request in December 2023 regarding further clinical trials. It resubmitted its BLA to the FDA in February 2025 based on positive results of the NORSE EIGHT clinical trial, announced in January 2025. A second CRL (issued in August 2025) recommended that Outlook submit additional efficacy data to support its application for Lytenava™. Outlook resubmitted its BLA to the FDA for a second time in early November 2025.
Lytenava™ was approved in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025. The Scottish Medicines Consortium 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.