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Outlook Therapeutics Announces NICE Recommendation of LYTENAV (bevacizumab gamma) for the Treatment of Wet AMD

December 6, 2024 – – biopharmaceuticals, outlook therapeutics, vision, wet muscular degeneration

First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025

LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK)

40,000 new wet AMD patients each year in the UK who could benefit from treatment

ISELIN, N.J., December 4, 2024 — (GLOBE NEWSWIRE) Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma), as an option for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity.

“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,” commented Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics. “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 LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA).

Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King’s College Hospital and Professor of Retinal Research, King’s College London, commented, “It is good news that bevacizumab gamma will be available for patients in England and Wales on the NHS. LYTENAVA™ (bevacizumab gamma) is the first licensed ophthalmic formulation of bevacizumab. Despite not previously being approved for ophthalmic use, bevacizumab has been widely used to treat wet-AMD outside the UK and the approval by NICE marks significant progress towards ophthalmologists being able to use licensed bevacizumab for wet AMD in the UK. Importantly, 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.”

“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,” said Alexander Silvester, Chief Medical Officer, SpaMedica.

The positive NICE recommendation was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010 / LYTENAVA™, 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.

As part of a 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. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients.

About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet age-related macular degeneration (wet AMD).

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.

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 development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, 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 to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Visit: https://outlooktherapeutics.com/