FDA Approves Veligrotug-vvze (Lumvoa) for Thyroid Eye Disease
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved veligrotug-vvze (Lumvoa; Viridian Therapeutics) to treat thyroid eye disease (TED), regardless of disease activity or duration, making it the first approved therapy in this class to carry labeling that includes data from both active and chronic TED.
Approval was based on results from two pivotal Phase III studies: THRIVE, which enrolled patients with active TED, and THRIVE-2, which enrolled patients with chronic TED. Both trials met their primary and all secondary end points, with statistically significant and clinically meaningful improvements reported at week 15 across key signs and symptoms of TED.
Patients in both trials received five intravenous infusions administered every three weeks over a 12-week course. Reductions in proptosis were observed as early as week three. Veligrotug-vvze is the first approved TED therapy to demonstrate a statistically significant effect on both diplopia response rate and complete resolution of diplopia in both active and chronic disease populations.
Viridian Therapeutics announced plans for immediate commercial availability.
References
FDA approves veligrotug-vvze (Lumvoa) for thyroid eye disease across active and chronic stage. Opthalmology Times Staff Reports, June 27, 2026. Accessed at www.ophthalmologytimes.com/view/fda-approves-veligrotug-vvze-lumvoa-for-thyroid-eye-disease-across-active-and-ch.