Lumvoa gains US FDA approval for thyroid eye disease with class-first broad label

The US FDA has approved veligrotug-vvze (Lumvoa; Viridian Therapeutics) for thyroid eye disease (TED), with a label encompassing both active and chronic disease regardless of activity or duration—the first approved therapy in its class to carry such broad labelling.¹ The biologics licence application received Priority Review, and the company has announced plans for immediate commercial availability.¹

“The Lumvoa development program was a robust evaluation of the drug across the full spectrum of TED, including both active and chronic disease, showing significant improvements in outcomes that matter to patients and clinicians,” said Michael Yen, MD, professor of oculoplastic surgery and ophthalmology at Baylor College of Medicine and an investigator in the THRIVE program. “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.”

THRIVE Program: Trial design and key findings

FDA approval was supported by results from two pivotal phase 3 studies: THRIVE, which enrolled patients with active TED, and THRIVE-2, which enrolled patients with chronic TED. According to the sponsor, 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.¹

Patients in both trials received five intravenous infusions administered every 3 weeks over a 12-week course. The sponsor reported that reductions in proptosis were observed as early as week 3. Veligrotug-vvze is described by the company as 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.¹

Detailed efficacy data, including effect sizes for proptosis and diplopia endpoints, have not yet been published in peer-reviewed literature at the time of this report, which limits independent assessment of the magnitude of clinical benefit.

Clinical context: TED burden and treatment landscape

TED is a rare autoimmune orbitopathy most commonly associated with Graves disease, characterized by inflammatory infiltration and remodeling of orbital soft tissues.² The clinical sequelae—proptosis, diplopia, periorbital pain, and compressive optic neuropathy—can cause significant functional impairment and psychosocial morbidity.² Disease activity is typically stratified using validated tools such as the Clinical Activity Score, with management differing meaningfully between active and chronic phases.

Until the 2020 approval of teprotumumab (Tepezza; Amgen/Horizon), a first-in-class IGF-1R inhibitor, TED had no FDA-approved systemic therapy.³ Teprotumumab established proof-of-concept for IGF-1R inhibition in TED and demonstrated significant proptosis and diplopia reductions in phase 2 and phase 3 trials.³ However, its label is primarily supported by data in active TED, and concerns regarding hearing loss have shaped prescribing patterns.³

Mechanism of action and drug background

Veligrotug-vvze is a monoclonal antibody and full antagonist of the insulin-like growth factor-1 receptor (IGF-1R). IGF-1R signaling in orbital fibroblasts is implicated in the inflammatory cascade underlying TED through cross-talk with the thyroid-stimulating hormone receptor (TSHR).² Full receptor antagonism, as opposed to partial blockade, may theoretically offer more complete pathway inhibition, though comparative clinical data between agents in this class are not currently available.

Viridian also received Breakthrough Therapy Designation for veligrotug-vvze prior to approval.¹ The company is separately advancing elegrobart, a subcutaneous investigational IGF-1R–targeting therapy in TED, with a biologics license application submission anticipated in the first quarter of 2027.

Safety considerations

The approved prescribing information identifies several adverse effects warranting monitoring. Infusion reactions occurred in approximately 9% of patients and were generally mild to moderate in severity.¹ Hyperglycemia was reported in 12% of patients, including those without preexisting diabetes. Hearing impairment, including potentially permanent hearing loss, is identified as a risk—a signal consistent with the broader IGF-1R inhibitor class.³ Additional adverse reactions occurring in 5% or more of patients include muscle spasms, headache, fatigue, diarrhea, nausea, nasopharyngitis, elevated creatine phosphokinase, dry skin, and hypertension. The label also identifies a risk of inflammatory bowel disease exacerbation and includes contraception guidance for females of reproductive potential.

Limitations and next steps

Independent peer-reviewed publication of the THRIVE and THRIVE-2 trial data remains outstanding, limiting external validation of efficacy and safety claims. Head-to-head comparisons with teprotumumab are not available, precluding conclusions about relative efficacy or safety between approved agents. The 12-week treatment course and durability of response beyond week 15 merit further characterization in post-marketing studies. Physicians should counsel patients on the hearing impairment risk and establish audiologic baseline assessments before initiating therapy.

References

1. Viridian Therapeutics announces US FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease. Viridian Therapeutics, Inc. News release. June 26, 2026. Accessed June 27, 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 (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67. https://doi.org/10.1530/EJE-21-0479

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. https://doi.org/10.1056/NEJMoa1910434

4. Smith TJ, Janssen JAMJL. Insulin-like growth factor-I receptor and thyroid-associated ophthalmopathy. Endocr Rev. 2019;40(1):236-267. https://doi.org/10.1210/er.2018-00066