Outlook Therapeutics, Inc.

This biopharmaceutical company develops ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab. This product is approved by the European Commission in the European Union and the Medicines and Healthcare products Regulatory Agency in the United Kingdom for treating wet age-related macular degeneration (wet AMD) in adults. The company launched ONS-5010/LYTENAVA directly into Germany and the UK in June 2025. A Biologics License Application for ONS-5010/LYTENAVA for wet AMD treatment is currently under review by the U.S. Food and Drug Administration. The company aims to launch directly in the United States if approved. It may also seek approval for ONS-5010/LYTENAVA in other markets. ONS-5010/LYTENAVA is manufactured in the United States. Bevacizumab is a full-length, humanized anti-VEGF recombinant monoclonal antibody that inhibits VEGF and associated angiogenic activity. Before ONS-5010/LYTENAVA's approval in the EU and UK, bevacizumab was only approved for various cancer treatments and not optimized for retina diseases. The company submitted standard biologic therapeutic applications for ONS-5010/LYTENAVA, not using the biosimilar drug regulatory pathway, as bevacizumab was not an approved drug for retinal diseases in the United States and other major markets. Off-label repackaged bevacizumab is a frequently used first-line anti-VEGF treatment, with approximately 2.8 million injections annually in Europe and approximately 2.7 million injections annually in the United States.