Outlook Therapeutics announced the first commercial sales of LYTENAVA™ in Europe for wet AMD treatment. Financial results show a net loss of $20.2 million and $1.5 million of revenue for the fiscal third quarter ended June 30, 2025. The FDA PDUFA goal date for ONS-5010 is August 27, 2025. Adjusted net loss was $15.8 million.

LYTENAVA™ (bevacizumab gamma) is now available in Germany and the UK for wet AMD. Off-label repackaged bevacizumab is widely used in Europe and the US for retinal diseases. Outlook Therapeutics collaborates with Cencora for global commercial launch. ONS-5010/LYTENAVA™ aims to mitigate risks of off-label bevacizumab use.

FDA acknowledged the resubmission of the BLA for ONS-5010 (bevacizumab-vikg) for wet AMD treatment. The BLA is under Class 2 review with a PDUFA goal date of August 27, 2025. ONS-5010, if approved, will receive 12 years of regulatory exclusivity. Data from the NORSE EIGHT trial supports the BLA resubmission.

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for wet AMD treatment. In the US, ONS-5010/LYTENAVA™ is investigational. Outlook Therapeutics focuses on enhancing bevacizumab treatment for retina diseases. Financial results show a net loss of $20.2 million for the fiscal third quarter ended June 30, 2025, with $8.9 million in cash and cash equivalents as of June 30, 2025.

Read more at GlobeNewswire: Outlook Therapeutics Reports Financial Results for Third