European Commission Marketing Authorization for LYTENAVA (bevacizumab gamma) for the Treatment of Wet AMD
LYTENAVA™ (bevacizumab gamma) becomes first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD / Advancing toward commercial launch of LYTENAVA™ (bevacizumab gamma) in EU expected in calendar Q1 2025
Outlook Therapeutics announced that the European Commission has granted Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. It 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 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.
“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,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.
Jedd Comiskey, Senior VP – Head of Europe for Outlook Therapeutics, added, “Our team is working hand in hand with our commercialization partner, Cencora, to support our EU launch anticipated in the first calendar quarter of 2025. We look forward to further solidifying our global launch strategy and to an exciting year ahead.”
As part of the Company’s multi-year planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA globally following regulatory approvals.
About ONS-5010 / LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma)
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the commercialization and development of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD, DME and BRVO. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission Marketing Authorization for the treatment of wet AMD. Outlook is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and has also filed a MAA for ONS-5010 as a treatment for wet AMD in the UK. In the United States, ONS-5010/LYTENAVA™ is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD and if successful, the data may be sufficient for Outlook to resubmit a BLA application to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO.
Source: Outlook Therapeutics