Outlook moves toward potential US nod for thrice-snubbed eye drug with FDA appeal win

Summary: Outlook Therapeutics just won a big fight with the FDA. Their eye drug, Lytenava, treats a vision problem called wet AMD. The FDA rejected the drug three times before, asking for more proof that it worked. But Outlook appealed the decision and won! Now, the FDA agrees the drug is effective. Outlook will submit their application again next month, and their stock price jumped 29% after the good news. If approved, it will be the first official eye version of a popular cancer drug that doctors already use off-label.

For more details, see rssapp-fiercepharma-com at fiercepharma.com/pharma/outlook-marches-toward-hopeful-us-nod-thrice-snubbed-eye-drug-after-chalking-fda-appeal-win (opens in new tab)