FDA Approves New Treatment for Thyroid Eye Disease

Phase 3 THRIVE and THRIVE-2 trials supported approval following improvements in proptosis and diplopia in active and chronic disease.

By
Kathryn Wighton
June 29, 2026
3 min

MDSpire News

Objective:

To announce the FDA approval of veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease (TED).

Approach:

Clinical Trials: The approval was supported by the phase 3 THRIVE trial for active TED and the phase 3 THRIVE-2 trial for chronic TED, both meeting primary and secondary endpoints at week 15.
Treatment Administration: Patients received 5 intravenous infusions every 3 weeks over a 12-week treatment course.
Patient Support Program: ViridianCares provides patient access liaisons, insurance support, benefit verification, and financial assistance for eligible patients.

Key Findings:

Reductions in proptosis were observed as early as 3 weeks after treatment initiation, according to Viridian.
Lumvoa showed statistically significant effects on diplopia response and complete resolution of diplopia, as reported in the phase 3 trials.

Interpretation:

The Lumvoa development program evaluated the drug across the full spectrum of TED, demonstrating significant improvements in patient-relevant outcomes.

Limitations:

Lumvoa carries warnings for infusion reactions, inflammatory bowel disease exacerbation, hyperglycemia, and hearing impairment, as noted in the safety information from Viridian.
Infusion reactions occurred in approximately 9% of treated patients, and hyperglycemia occurred in 12%, according to the safety data.