Outlook Therapeutics Wins FDA Appeal for Retinal Drug LYTENAVA

Event Summary

The U.S. FDA granted Outlook Therapeutics' appeal for the retinal drug LYTENAVA following a Formal Dispute Resolution process. The company plans to resubmit its biologics license application in June 2026. If approved, LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab with FDA-approved manufacturing and labeling.