FDA Approval

FDA Approves Veligrotug-Vvze (Lumvoa) for Thyroid Eye Disease

Edited by:
Anthony Calabro, MA

Key Highlights

  • FDA approved veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease (TED) regardless of disease activity or duration.
  • Approval was supported by the pivotal phase 3 THRIVE (active TED) and THRIVE-2 (chronic TED) clinical trials.
  • Both trials met their primary and all secondary endpoints, with reductions in proptosis observed as early as 3 weeks and statistically significant effects on diplopia response and complete resolution of diplopia.
  • The FDA granted approval under Priority Review.

On June 26, 2026, the FDA approved veligrotug-vvze (Lumvoa, Viridian Therapeutics) for the treatment of thyroid eye disease (TED) regardless of thyroid eye disease activity or duration. Veligrotug is a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R). According to the FDA approval announcement, veligrotug-vvze is the first approved treatment for thyroid eye disease with labeling that includes data from both active and chronic disease. The FDA approved the application under Priority Review, and the therapy previously received Breakthrough Therapy Designation.

The approval was supported by the pivotal phase 3 THRIVE trial in patients with active TED and the phase 3 THRIVE-2 trial in patients with chronic TED. Both studies met their respective primary and all secondary endpoints at week 15. Across both studies, patients received a 12-week course of treatment.

The company reported reductions in proptosis as early as 3 weeks and stated that veligrotug-vvze was the first approved TED therapy to demonstrate a statistically significant effect on both diplopia response and complete resolution of diplopia in patients with active and chronic disease.

Warnings and precautions include infusion reactions, inflammatory bowel disease exacerbation, hyperglycemia, and hearing impairment, including hearing loss that may be permanent. Infusion reactions occurred in approximately 9% of treated patients and were generally mild to moderate. Hyperglycemia occurred in 12% of patients in clinical trials, with one-half of affected patients having preexisting diabetes or impaired glucose tolerance.

The most common adverse reactions (incidence ≥5%) were muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension.

Veligrotug-vvze is supplied as a 500-mg injection for intravenous infusion. Treatment consists of 5 intravenous infusions administered every 3 weeks over a 12-week course. The prescribing information recommends implementing effective contraception before treatment, during treatment, and for 6 months after the final dose in females of reproductive potential.

Reference
Viridian Therapeutics. Viridian Therapeutics announces U.S. FDA approval and launch of Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease. Published June 26, 2026. Accessed July 6, 2026. https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-u-s-fda-approval-and-launch-of-lumvoa-veligrotug-vvze-for-the-treatment-of-thyroid-eye-disease