Outlook Therapeutics Launches LYTENAVA for Wet AMD in Germany and UK

Outlook Therapeutics, Inc., a biopharmaceutical company focusing on improving treatments for retinal diseases, has announced the commercial availability of LYTENAVA™ (bevacizumab gamma) in Germany and the United Kingdom. LYTENAVA™ is recognized as the first and only ophthalmic formulation of bevacizumab approved for treating wet age-related macular degeneration (wet AMD) in both the European Union and the UK.

The launch of LYTENAVA™ marks a significant step for Outlook Therapeutics. As noted by Jedd Comiskey, Senior Vice President and Head of Europe at Outlook Therapeutics, the company is keen to maintain its momentum in Germany and the UK and is preparing for further launches in the region throughout the year and into 2026.

Currently, in Europe, approximately 2.8 million injections of repackaged off-label bevacizumab are administered each year as a primary anti-VEGF treatment for retinal conditions. This practice is also prevalent in the United States, with about 2.7 million injections annually. LYTENAVA™ presents an opportunity to address certain risks tied to the off-label use of repackaged bevacizumab.

To support the worldwide commercial launch of LYTENAVA™, Outlook Therapeutics has partnered strategically with Cencora, formerly AmerisourceBergen. This collaboration aims to ensure comprehensive market access and streamline distribution across European markets, with potential expansion into the United States pending regulatory approval.

LYTENAVA™, also known as ONS-5010 or bevacizumab-vikg in the United States, is an innovative ophthalmic formulation of bevacizumab specifically designed for wet AMD treatment. This formulation works by binding selectively to all isoforms of vascular endothelial growth factor (VEGF), effectively blocking its biological activity. By inhibiting VEGF's interaction with its receptors on endothelial cells, LYTENAVA™ reduces cell proliferation, vascular leakage, and the formation of new blood vessels in the retina.

The European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have granted centralized marketing authorizations for LYTENAVA™. However, in the United States, it remains investigational, with a Biologics License Application (BLA) resubmitted to the FDA. If approved, it would be the first authorized ophthalmic formulation of bevacizumab for retinal indications like wet AMD in the U.S.

Outlook Therapeutics remains committed to its mission of introducing LYTENAVA™ to new markets. They are actively working to meet pricing and reimbursement prerequisites in various EU Member States, in anticipation of widespread commercial availability.

Focused on enhancing the standard of care for bevacizumab treatments, Outlook Therapeutics is looking to establish LYTENAVA™ as a leading solution for wet AMD. The company is optimistic about the potential impact of LYTENAVA™ on the treatment landscape, given its strategic market introduction and collaboration with key partners such as Cencora.

Overall, the introduction of LYTENAVA™ is poised to offer a safer and efficacious alternative to current treatments, potentially transforming patient outcomes in Europe and, upon regulatory approval, in the United States.