Outlook Therapeutics receives positive CHMP opinion from European Medicines Agency for bevacizumab

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Biopharmaceutical company Outlook Therapeutics, Inc. announced the European Medicines Agency (EMA) has issued a positive Committee for Medicinal Products for Human Use (CHMP) opinion. The positive opinion concerns authorization of bevacizumab gamma (ONS-5010/LYTENAVA), a formulation of bevacizumab for treatment of wet age-related macular degeneration (wet AMD).

In a news release, Outlook Therapeutics stated the European Commission is expected to decide on the application for ONS-5010 within approximately 67 days.¹ The ruling will automatically apply to all 27 EU member states; after 30 days, the decision will also apply in Iceland, Liechtenstein and Norway. Outlook Therapeutics will assess commercialization of the product and partnerships in Europe on a country-by-country basis.

Recently, in the US, Outlook stocks underwent a 1-for-20 reverse stock split after the FDA issued a CRL for the company’s ONS-5010 back in August 2023.

The company stated bevacizumab-vikg/bevacizumab gamma 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.”

In a previous video interview² with Ophthalmology Times Europe about the development of bevacizumab gamma, Dr Firas Rahhal explained the new ophthalmic preparation for bevacizumab, in a summary of the Phase 3 NORSE TWO trials. “Bevacizumab is a drug we use a lot; currently, for wet macular degeneration and other diseases, but we use it in a compounded form. Something that compounding pharmacies prepare off the intravenous version, and that makes it off-label,” he explained. “What we're doing now is developing this ophthalmic solution made specifically for the eye of the same drug, essentially the same drug, for wet macular degeneration.”

Russell Trenary, President and CEO of Outlook Therapeutics, said the positive opinion represents “a significant milestone” for the company and the treatment of wet AMD throughout Europe.¹ “We are proud to be one step closer to bringing to the EU market the first and only on-label, ophthalmic bevacizumab for the treatment of wet AMD, if approved,” he said.

Results across the first three NORSE trials³ demonstrated a strong benefit-to-risk safety profile, with only one ocular inflammation adverse event across all three registration trials. The most common adverse reaction (≥ 5%) reported in patients receiving bevacizumab-vikg was conjunctival hemorrhage associated with the needle injection procedure (5%).

NORSE ONE was a clinical experience trial involving 61 wet AMD participants at nine trial sites in Australia, and compared bevacizumab-vikg to ranibizumab (LUCENTIS) as a treatment for wet AMD. Bevacizumab-vikg efficacy and safety data were consistent with historical published studies of bevacizumab in ophthalmology.

In the NORSE TWO Phase 3 pivotal trial, investigators enrolled a total of 228 wet AMD patients at 39 sites in the US. It was designed as a superiority study comparing the safety and efficacy of bevacizumab-vikg ophthalmic bevacizumab dosed monthly against ranibizumab, dosed according to the regimen described in the Lucentis label. The data met both the primary and secondary endpoints with high statistical significance and clinical relevance.

NORSE THREE was an open-label safety study of bevacizumab-vikg in 197 patients conducted in the US to provide the necessary number of retina patients dosed with bevacizumab-vikg 5010 to complete the safety requirements for submitting a biologics license application.

References:

1. Outlook Therapeutics. Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD. News release. Published 22 March, 2024. https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-receives-european-union-positive-chmp

2. Kaiser Maharjan, E. Phase 3 NORSE TWO proves ophthalmic bevacizumab effectively treats wet macular degeneration. Ophthalmology Times Europe. Published 26 January, 2022. Accessed 22 March, 2024. https://europe.ophthalmologytimes.com/view/phase-3-norse-two-proves-ophthalmic-bevacizumab-effectively-treats-wet-macular-degeneration

3. Hutton, D. BREAKING: US FDA issues CRL for Outlook Therapeutics’ ONS-5010. Ophthalmology Times Europe. Published 30 August, 2023. Accessed 22 March, 2024. https://europe.ophthalmologytimes.com/view/breaking-news-us-fda-issues-crl-outlook-therapeutics-ons-5010