Outlook Therapeutics Receives European Authorization for Lytenava for the Treatment of Wet AMD

Outlook Therapeutics has received European Commission Marketing Authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD. Lytenava is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU.

The application for European Commission Marketing Authorization of Lytenava is a mixed application grounded on Article 8.3 of Directive 2001/83/EC and is based on the results from Outlook’s wet AMD clinical program, which consists of three completed registration clinical trials—NORSE ONE, NORSE TWO and NORSE THREE—as well as studies and peer reviewed literature substituting or supporting certain tests and studies, according to Outlook. This decision applies automatically in all 27 EU Member States and, within 30 days, also to Iceland, Norway and Liechtenstein. Additionally, the Marketing Authorization grants Outlook an initial 10 years of market exclusivity in the EU for Lytenava.

“This is a landmark milestone for us. We are extremely pleased to receive Marketing Authorization for Lytenava (bevacizumab gamma) in the EU and are moving toward our potential first commercial launch in an EU member state in the first calendar quarter of 2025," Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics said in a company news release. "The EU represents the second largest wet AMD market in the world, and we look forward to continuing our efforts to bring to the EU market the first and only on-label, ophthalmic bevacizumab for the treatment of wet AMD. We are incredibly grateful to all the patients, researchers, clinical sites and the European Medicines Agency for the research, drug development, and regulatory efforts that led to this approval."

As part of the company’s multi-year planning process, Outlook entered a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of Lytenava globally following regulatory approvals.

Cencora will provide launch support in Europe, including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics (3PL), distribution and field solutions. The collaboration and integrated approach will support market access and efficient distribution of Lytenava.

In the United States, ONS-5010/Lytenava is currently being evaluated in an ongoing non-inferiority study for the treatment of wet AMD.