Outlook Therapeutics Resubmits ONS-5010 BLA

MiNK Therapeutics has resubmitted its Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg) to the United States — Food and Drug Administration (FDA) for the treatment of neovascular age-related macular degeneration (nAMD). This follows a successful appeal where the FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established, eliminating the need for additional trials. The FDA's decision directs its Division of Ophthalmology and Office of Specialty Medicine to work with MiNK Therapeutics on final product labeling, with a Class 1 resubmission status indicating a decision within 60 days. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab, offering a new treatment option for wet AMD patients in the United_States. MiNK Therapeutics has already launched LYTENAVA (bevacizumab gamma) in Germany, Austria, and the United Kingdom.