The company said LYTENAVA is the first and only FDA-approved ophthalmic bevacizumab for treating wet age-related macular degeneration, marking a regulatory milestone for the drug.
Outlook Therapeutics said the U.S. Food and Drug Administration approved LYTENAVA for the treatment of wet AMD (age-related macular degeneration, an eye disease). The company described the product as the first and only FDA-approved ophthalmic bevacizumab for that indication, a notable step because bevacizumab has been widely used in ophthalmology through repackaged or off-label formats rather than as an approved ophthalmic medicine. The approval gives Outlook Therapeutics a formal regulatory clearance that could shape physician adoption, reimbursement and commercialization in the wet AMD market.