Outlook Therapeutics, Inc.: bevacizumab-vikg

There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in § 314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling.

In NORSE EIGHT, !®) (bevacizumab-vikg) injection did not meet the primary efficacy endpoint of mean change from baseline in ETDRS BCVA score at the Week 8 visit in comparison to ranibizumab using a non-inferiority margin of -3.5 letters.