Outlook Therapeutics announces CHMP of EMA issued positive opinion on ONS-5010

Outlook Therapeutics 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, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration 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(TM) 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.