Reported Saturday, FDA Accepts Genentech’s Vamikibart BLA For Uveitic Macular Edema With Approval Decision Expected By July 2027, Following Phase III Data Showing Sustained Improvements At 52 Weeks

The FDA has accepted Genentech's Biologics License Application (BLA) for Vamikibart, targeting Uveitic Macular Edema (UME), with a decision expected by July 2027. Phase III studies, MEERKAT and SANDCAT, showed sustained improvements in vision and reductions in macular thickness at 52 weeks. UME is a leading cause of severe vision loss in uveitis patients, highlighting the importance of this treatment.