On Friday, the U.S. Food and Drug Administration (FDA) approved Outlook Therapeutics Inc.’s (NASDAQ:OTLK) ONS-5010/LYTENAVA (bevacizumab-vikg, bevacizumab gamma) for neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.
The regulatory milestone distinguishes LYTENAVA as the inaugural and sole FDA-approved ophthalmic formulation of bevacizumab designed specifically for wet AMD treatment within the United States.
The approval comes after the drug has received three FDA rejections.
Setting New Standard in Retina Care
For the first time, retina specialists and patients have an FDA-backed bevacizumab option tailored exclusively for ocular use.
