Outlook Therapeutics Receives NICE Recommendation of Lytenava for Wet AMD

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Lytenava (bevacizumab gamma) as an option for the treatment of wet AMD in adults. This marks the first positive reimbursement decision for Lytenava worldwide and supports its commercialization strategy in the United Kingdom and Europe.

Lytenava is the first authorized ophthalmic formulation of bevacizumab for wet AMD in the European Union (EU) and the UK, where it enjoys 10 years of market exclusivity. This treatment leverages the selective neutralization of vascular endothelial growth factor (VEGF) to prevent blood vessel proliferation and leakage in the retina, a hallmark of wet AMD.

“We are very pleased to receive the NICE recommendation of Lytenava (bevacizumab gamma) for patients with wet AMD. As the first positive reimbursement decision worldwide, this builds on our momentum and bolsters our commercialization strategy moving forward,” Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics, said in a company news release. “We remain committed to providing the UK health system with a cost effective treatment option for treating wet AMD. Looking ahead, our team continues preparations for commercial launch in the UK anticipated in 2025 and continues to work through the pricing and reimbursement processes for EU countries, with launches in the EU anticipated to follow.”

NICE is an executive non-departmental public body responsible for providing guidance on the promotion of good health and the prevention and treatment of ill health in the UK, considering clinical effectiveness and value for money. The NICE recommendation applies to England and Wales and follows the recent Marketing Authorization for (beva Lytenavacizumab gamma) for the treatment of wet AMD by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA).

The NICE recommendation is based on results from Outlook Therapeutics’ wet AMD clinical program, which includes three pivotal registration trials—NORSE ONE, NORSE TWO, and NORSE THREE. These studies demonstrated the safety, efficacy, and consistency of Lytenava in treating wet AMD.

As part of its long-term strategy, Outlook Therapeutics has partnered with Cencora (formerly AmerisourceBergen) to support Lytenava's global commercialization.