FDA approves veligrotug-vvze for thyroid eye disease

First TED approval supported by active and chronic disease data

The FDA has approved veligrotug-vvze (Lumvoa; Viridian Therapeutics, Waltham, MA, USA) for the treatment of thyroid eye disease (TED), regardless of disease activity or duration.¹

Veligrotug-vvze is an intravenously administered, full antagonist monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R). According to Viridian, Lumvoa is the first approved treatment for TED with labeling that includes data from both active and chronic disease.

TED is a rare autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes. The condition can lead to proptosis, diplopia, pain and vision impairment, with a substantial impact on daily function and quality of life.^2,3

FDA approval was supported by two pivotal phase 3 studies: THRIVE (NCT05176639),⁴ which enrolled patients with active TED, and THRIVE-2 (NCT06021054), which enrolled patients with chronic TED. According to the company, both trials met their primary and all secondary endpoints, with statistically significant and clinically meaningful improvements reported at Week 15 across key signs and symptoms of TED.

Patients received five intravenous infusions administered every 3 weeks over a 12-week treatment course. Viridian reported that reductions in proptosis were observed as early as Week 3. The company also stated that Lumvoa is the first approved product for TED to show a statistically significant effect on both diplopia response and complete resolution of diplopia in active and chronic TED.

The approved prescribing information includes warnings and precautions for infusion reactions, inflammatory bowel disease, hyperglycemia and hearing impairment, including hearing loss that may be permanent.⁵ Infusion reactions were reported in approximately 9% of patients treated with Lumvoa and were usually mild or moderate. Hyperglycemia or increased blood glucose was reported in 12% of patients in clinical trials, half of whom had pre-existing diabetes or impaired glucose tolerance.

The most common adverse reactions, occurring in 5% or more of patients, included muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhoea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin and hypertension.

Lumvoa was granted Breakthrough Therapy Designation and Priority Review by the FDA. Viridian announced plans to launch the treatment immediately in the USA and said physicians would be able to prescribe Lumvoa from June 27, 2026. The company is also advancing elegrobart, an investigational subcutaneous IGF-1R-targeting therapy for TED, with a biologics licence application submission anticipated in the first quarter of 2027.

References:

1. Viridian Therapeutics. Viridian Therapeutics announces US FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease. Press release. June 26, 2026. Available at: https://investors.viridiantherapeutics.com/news/news-details/2026/Viridian-Therapeutics-Announces-U-S–FDA-Approval-and-Launch-of-Lumvoa-veligrotug-vvze-for-the-Treatment-of-Thyroid-Eye-Disease/default.aspx (accessed June 20, 2026).
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:G43–G67.
3. Bahn RS. Graves’ ophthalmopathy. N Engl J Med. 2010;362:726–738.
4. Lumvoa (veligrotug-vvze) prescribing information. Viridian Therapeutics, Inc. 2026.
5.  Yen MT, Cockerham K, Saeed P, et al. Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of Veligrotug for Active Thyroid Eye Disease. Ophthalmology. 2026; Epub ahead of print. DOI: 10.1016/j.ophtha.2026.04.022