CHMP positive for Lytenva (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) in the EU .- Outlook Therapeutics Inc.,
Outlook Therapeutics, Inc. 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/Lytenva (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 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/Lytenva.
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