Outlook Therapeutics has achieved a significant regulatory milestone with the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the United Kingdom for the treatment of wet age-related macular degeneration (wet AMD). The drug represents the first and only authorized ophthalmic formulation of bevacizumab for treating wet AMD in adults across the European Union and UK.
The launch addresses a substantial unmet medical need in the European market, where approximately 2.8 million injections of repackaged off-label bevacizumab are administered annually for retinal diseases. In the United States, a similar volume of approximately 2.7 million injections occurs annually, highlighting the widespread use of bevacizumab in ophthalmology despite the lack of approved ophthalmic formulations.
Regulatory Achievement and Market Positioning
LYTENAVA™ (bevacizumab gamma) has received centralized Marketing Authorization from the European Commission in the EU and Marketing Authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This regulatory approval positions the drug as a potential safer alternative to current off-label repackaged bevacizumab treatments.
"We are excited to have launched LYTENAVA™ (bevacizumab gamma) for patients with wet AMD in Germany and the UK," commented Jedd Comiskey, Senior Vice President, Head of Europe at Outlook Therapeutics. "Going forward, we remain laser focused on ensuring success in Germany and the UK as well as preparing for additional launches across the region later this year and throughout 2026."
Mechanism of Action and Clinical Profile
LYTENAVA™ is a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF). The drug neutralizes VEGF's biologic activity through steric blocking of VEGF binding to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on endothelial cell surfaces.
Following intravitreal injection, bevacizumab binding to VEGF prevents the interaction of VEGF with its receptors on endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. This mechanism directly addresses the pathophysiology underlying wet AMD.
Commercial Strategy and Distribution Partnership
Outlook Therapeutics has established a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the global commercial launch of LYTENAVA™ following regulatory approvals. The collaboration employs an integrated approach designed to support market access and efficient distribution to benefit retina specialists, healthcare providers, and patients in European markets and potentially in the United States if approved.
The company plans to expand commercial availability across additional European countries later in 2025 and throughout 2026, pending pricing and reimbursement approvals in certain EU member states where such approvals are required before commercial sale.
U.S. Development Status
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) remains investigational, with a Biologics License Application (BLA) resubmitted to the FDA. If approved by U.S. regulators, ONS-5010/LYTENAVA™ would become the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, in the United States.
The potential U.S. approval would address the same market dynamics observed in Europe, where off-label repackaged bevacizumab serves as one of the most frequently used first-line anti-VEGF treatments for retinal diseases. ONS-5010/LYTENAVA™ has potential to mitigate certain risks associated with current off-label use of repackaged bevacizumab in both markets.
