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

• In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks
• UME is the leading cause of moderate and severe vision loss in patients with uveitis, posing a significant risk of blindness if left untreated

The FDA has accepted Genentech’s Biologics License Application (BLA), with an approval decision expected by July 2027