India, June 16 -- Outlook Therapeutics, Inc. (OTLK) announced that the U.S. FDA has accepted its resubmitted BLA for ONS-5010/LYTENAVA as a proposed treatment for neovascular age-related macular degeneration, also known as wet AMD. The agency has classified the filing as a Class 1 review and assigned a PDUFA target action date of July 29, 2026.
Wet AMD is a progressive retinal disease that leads to vision loss due to abnormal blood vessel growth and fluid leakage in the retina. Current treatment often requires frequent intravitreal injections, and many patients rely on off-label formulations of bevacizumab that lack FDA-approved ophthalmic labelling.
About ONS-5010/LYTENAVA
ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab de...