Outlook Therapeutics has announced that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA (bevacizumab gamma) as an option for treating wet age-related macular degeneration (wet AMD) in adults. This decision marks the first positive reimbursement decision worldwide for LYTENAVA, the first ophthalmic formulation of bevacizumab authorized for wet AMD treatment in the European Union (EU) and the United Kingdom (UK).
The NICE recommendation, applicable to England and Wales, follows the Marketing Authorization granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). It paves the way for LYTENAVA to be available on the NHS and for Independent Sector Providers, offering a cost-effective treatment option.
Clinical Impact and Expert Commentary
Professor Tim Jackson, Consultant Ophthalmic Surgeon at King's College Hospital, noted the significance of the NICE approval, stating, "It is good news that bevacizumab gamma will be available for patients in England and Wales on the NHS...the licensing process puts in place a number of quality controls, and combined with reduced cost, this should provide a welcome, cost-effective treatment option for our patients."
Alexander Silvester, Chief Medical Officer at SpaMedica, added, "The approval by NICE makes LYTENAVA (bevacizumab gamma) the first and only ophthalmic bevacizumab to be available on the NHS and for Independent Sector Providers, which is a stride in the right direction for the patients needing anti-VEGF treatments to control their wet AMD."
Commercialization Strategy
Outlook Therapeutics anticipates launching LYTENAVA in the UK in the first half of 2025. The company is also working through pricing and reimbursement processes for EU countries, with launches in the EU expected to follow. Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics, stated, "We remain committed to providing the UK health system with a cost effective treatment option for treating wet AMD."
About LYTENAVA (bevacizumab gamma)
LYTENAVA is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of human vascular endothelial growth factor (VEGF), neutralizing VEGF's biologic activity. By blocking VEGF, LYTENAVA reduces endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. It is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in the EU and UK, holding an initial 10 years of market exclusivity.
Ongoing Development in the US
In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD. Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025, pending full month 3 efficacy and safety results from the NORSE EIGHT trial.
