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Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD
Positive opinion serves as a basis for final decision for potential authorization from the European Commission (EC), expected within 67 days ISELIN, N.J.,
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Positive opinion serves as a basis for final decision for potential authorization from the European Commission (EC), expected within 67 days ISELIN, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the EU. Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis. “The CHMP positive opinion for ONS-5010/LYTENAVA™ represents a significant milestone for Outlook Therapeutics and advancement in the treatment of wet AMD in the EU. 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,” commented Russell Trenary, President and Chief Executive Officer. The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and bibliographic literature substituting or supporting certain tests and studies. If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA™. The CHMP’s positive opinion supports the grant of marketing authorization by the European Commission (EC) for Outlook Therapeutics’ application for ONS-5010. The EC is expected to make a decision within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no FDA o...