Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory Evidence September 14, 2026 By Mark A. Tobolowsky & Frank J. Sasinowski —

https://www.thefdalawblog.com/2026/09/confirmatory-evidence-for-all-fdas-approval-of-lytenava-for-wet-amd-shows-how-non-rare-diseases-can-use-confirmatory-evidence-and-that-failed-studies-can-provide-confirmato/?utm_source=rss&utm_medium=rss&utm_campaign=confirmatory-evidence-for-all-fdas-approval-of-lytenava-for-wet-amd-shows-how-non-rare-diseases-can-use-confirmatory-evidence-and-that-failed-studies-can-provide-confirmato On July 22, 2026, FDA approved Outlook Therapeutics, Inc.’s (“Outlook”) Lytenava (bevacizumab-vikg) for the treatment of neovascular (wet) age-related macular degeneration (“Wet AMD”). This approval was achieved after Outlook’s success through the Formal Dispute Resolution Request (“FDRR”) process following the receipt of multiple Complete Response Letters. HPM’s Frank Sasinowski and Mark Tobolowsky are honored to have aided Outlook Therapeutics in this successful FDRR win and approval, and at the FDRR meeting, HPM’s Frank Sasinowski was the lead speaker representing Outlook’s positions.