FDA Approves Veligrotug-vvze for Thyroid Eye Disease

The US Food and Drug Administration (FDA) has approved veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease (TED), with labeling for use regardless of disease activity or duration.¹

Announced by Viridian Therapeutics on June 26, 2026, the decision is based on positive results from the THRIVE and THRIVE-2 clinical trials investigating the intravenous insulin-like growth factor 1 receptor (IGF-1R) antagonist administered as 5 infusions every 3 weeks over 12 weeks. The approval was granted under Priority Review and follows Breakthrough Therapy Designation.¹

“It’s encouraging to see a new treatment for the full spectrum of the disease with data showing rapid onset of proptosis reduction as well as improvements in diplopia,” said Michael Yen, MD. “This is an exciting new option for physicians to offer their [patients with TED].”¹

FDA Approval Applies to Active and Chronic Thyroid Eye Disease

The approval was supported by 2 pivotal phase 3 trials: THRIVE, which enrolled patients with active TED, and THRIVE-2, which enrolled patients with chronic TED. Viridian reported that both studies met their primary endpoints and all secondary endpoints, with statistically significant improvements at week 15 across key signs and symptoms of TED. The company specifically reported reductions in proptosis as early as 3 weeks and statistically significant effects for diplopia response and complete resolution of diplopia in both active and chronic disease.¹

TED is an autoimmune inflammatory disorder associated with orbital tissue expansion and remodeling, which can result in proptosis, diplopia, pain, exposure symptoms, and, in severe cases, visual impairment. Guideline-based management has historically stratified treatment by disease activity and severity, with medical therapy emphasized in active moderate-to-severe disease and rehabilitative procedures often considered after disease inactivity.²

Veligrotug Mechanism and TED Treatment Context

Veligrotug targets IGF-1R, a pathway already established as clinically relevant in TED. Teprotumumab, another IGF-1R-directed monoclonal antibody, demonstrated improvements in proptosis and clinical activity vs placebo in a phase 3 trial involving patients with active TED. Veligrotug adds another FDA-approved IGF-1R antagonist option, but the available announcement does not include head-to-head data comparing veligrotug-vvze with other TED therapies.³

Veligrotug is the first approved TED treatment with labeling including data from both active and chronic TED trials. The company also stated it plans an immediate US launch and has established a patient support program.1 These access-related details may affect early availability, although coverage and prior authorization requirements were not detailed in the announcement.¹

Safety Findings Reported With Veligrotug

The safety information provided with the approval announcement includes warnings for infusion reactions, inflammatory bowel disease exacerbation, hyperglycemia, and hearing impairment, including hearing loss which may be permanent. Infusion reactions were reported in approximately 9% of Veligrotug-treated patients and may include transient blood pressure increases, fever, chills, headache, and fatigue.¹

Hyperglycemia or increased blood glucose occurred in 12% of patients in clinical trials, with approximately half of those patients having preexisting diabetes or impaired glucose tolerance.1 The prescribing information advises assessment for elevated blood glucose and symptoms of hyperglycemia before infusion and continued monitoring during treatment.¹

The label also recommends hearing assessment before, during, and after treatment because severe hearing impairment, including permanent hearing loss, may occur. The most common adverse reactions reported at an incidence of at least 5% included muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension. Females of reproductive potential are advised to use appropriate contraception before treatment, during therapy, and for 6 months after the final dose.¹

References

1. Viridian Therapeutics announces U.S. FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease. BusinessWire. Published June 26, 2026. Accessed June 29, 2026. https://www.businesswire.com/news/home/20260625016249/en/Viridian-Therapeutics-Announces-U.S.-FDA-Approval-and-Launch-of-Lumvoa-veligrotug-vvze-for-the-Treatment-of-Thyroid-Eye-Disease

2. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves’ orbitopathy clinical practice guidelines for the medical management of Graves’ orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67.

3. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020;382(4):341-352.