11:18 AM EDT, 05/13/2024 (MT Newswires) -- Outlook Therapeutics ( OTLK ) said Monday it Applied to the UK's Medicines and Healthcare products Regulatory Agency for marketing authorization for ONS-5010/Lytenava to treat wet age-related macular degeneration, or AMD.
The submission follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on the therapy, the company added.
The application was backed by results from three wet AMD registration clinical trials of ONS-5010, the company said.
ONS-5010/Lytenava, or bevacizumab gamma, is an ophthalmic formulation of bevacizumab that is being developed as an intravitreal injection for the treatment of wet AMD and other retinal diseases, the company said.
Shares of Outlook Therapeutics ( OTLK ) rose 5.5% in recent trading Monday.
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