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News|Articles|June 29, 2026

Treatment for Thyroid Eye Disease Approved by FDA

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Key Takeaways

  • FDA approval of veligrotug-vvze establishes a new IV biologic option for TED, a Graves-associated autoimmune orbitopathy marked by inflammatory remodeling, proptosis, diplopia, and potential vision-threatening sequelae.
  • THRIVE in active TED used 10 mg/kg every 3 weeks for five infusions and achieved week-15 proptosis responder rates of 70% versus 5% on Hertel, with concordant MRI/CT outcomes.
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Veligrotug-vvze (Lumvoa; Viridian Therapeutics) is the first treatment for thyroid eye disease that has been approved by the FDA.

The FDA announced the approval of the first treatment for thyroid eye disease (TED) with the approval of veligrotug-vvze (Lumvoa; Viridian).1 The treatment can be used to address the autoimmune disease that causes inflammation and tissue remodeling.

TED is a rare disorder that primarily affects tissues around the eyes. The condition can cause symptoms such as swelling and discomfort and most often occurs in patients with Graves disease.2 Symptoms of TED can include dry eyes, bulging eyes, light sensitivity, difficulty moving your eyes, and double vision, among other symptoms, with more severe cases potentially leading to vision loss. The approval of veligrotug could help in addressing the condition before symptoms progress.

The approval is based off results from the phase 3 THRIVE and THRIVE-2 trials, which evaluated patients with active and chronic TED, respectively.3 In the THRIVE trial, patients were randomized 2:1 to receive either the 10 mg/kg veligrotug or placebo doses. These were administered every 3 weeks for 5 intravenous (IV) infusions. The primary end point was proptosis responder rate (PRR) or overall responder rate (ORR).

The researchers found that improvements were seen as early as week 3, and week 15 saw significantly greater response. Notably, PRR was 70% in the veligrotug group vs 5% in the placebo group when measured by Hertel; this difference was maintained when PRR was measured by magnetic resonance imaging (MRI) or computed tomography (CT), with the veligrotug group having a PRR of 71% vs 9% in placebo. The ORR was 67% in the veligrotug group vs 5% in the placebo. No serious treatment-related adverse events were reported.

The THRIVE-2 trial evaluated patients with chronic TED who were randomized 2:1 to receive the 10 mg/kg dose of veligrotug or placebo.4 PRR and ORR were both evaluated in this group. Overall, 188 patients were included in the study, of which 125 received veligrotug. This trial saw similar results as THRIVE, with a PRR of 56% in the veligrotug group compared with 8% in the placebo group based on Hertel measurements. This was also found with MRI/CT measurements, as PRR was 48% in the veligrotug group vs 3% in the placebo. ORR was 56% in the veligrotug group vs 7% in the placebo. Treatment-related adverse events were primarily mild, with muscle spasms and menstrual disorders being the most reported by participants. A total of 2% of those in the veligrotug group reported a serious treatment-related adverse event, which amounted to 1 participant.

“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. This is an exciting new option for physicians to offer their TED patients,” said Michael Yen, MD, an investigator in the THRIVE program.1

Viridian Therapeutics aims to make veligrotug available as soon as possible as the first commercial product for TED that the company has released. Doctors and other physicians will be able to prescribe veligrotug to their patients without delay, and the medication will be available to patients now.

References

  1. Viridian Therapeutics announces U.S. FDA approval and launch of Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease. News release. Viridian. June 26, 2026. Accessed June 29, 2026. 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
  2. Thyroid eye disease (Graves’ eye disease). Cleveland Clinic. Updated March 2, 2025. Accessed June 29, 2026. https://my.clevelandclinic.org/health/diseases/17558-thyroid-eye-disease
  3. Yen MT, Cockerham K, Saeed P, et al; THRIVE study group. THRIVE: a phase 3, randomized, double-masked, placebo-controlled study of veligrotug for active thyroid eye disease. Ophthalmology. Published online June 1, 2026. doi:10.1016/j.ophtha.2026.04.022
  4. Jain AP, Cockerham K, Abrams J, et al. OR31-07 THRIVE-2 phase 3 trial of veligrotug (VRDN-001) in chronic thyroid eye disease (TED): efficacy and safety at 15 weeks. J Endocr Soc. 2025;9(Suppl 1):bvaf149.2240. doi:10.1210/jendso/bvaf149.2240

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