Lumvoa (veligrotug-vvze) is now FDA-approved to treat thyroid eye disease regardless of activity or duration, offering a new therapeutic option for both active and chronic phases.
The Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED) regardless of TED activity or duration
Veligrotug is a humanized IgG1 monoclonal antibody that inhibits the activity of insulin-like growth factor-1 receptor (IGF-1R). It is believed that inhibition of IGF-1R helps reduce orbital inflammation and associated tissue damage that occurs in TED patients
The approval was based on data from the phase 3 THRIVE (ClinicalTrials.gov Identifier: NCT05176639) and THRIVE-2 (ClinicalTrials.gov Identifier: NCT06021054) trials, which evaluated veligrotug in patients with active TED and chronic TED, respectively. In both trials, patients were randomly assigned to receive veligrotug 10mg/kg intravenously (IV) every 3 weeks for a total of 5 infusions or placebo. The primary endpoint was proptosis responder rate, defined as a reduction of proptosis of at least 2mm from baseline in the study eye without worsening in the fellow eye (≥2mm increase), as measured by exophthalmometry.
The THRIVE trial included 113 patients with moderate to severe active TED (onset within 15 months, clinical activity score of ≥3). Seventy-five patients received veligrotug and 38 patients received placebo. The proptosis responder rate at week 15 was 70% for the veligrotug group and 5% for the placebo group (treatment difference, 65% [95% CI, 52-78]; P <.01). The mean change in proptosis from baseline was -2.9mm for veligrotug-treated patients and -0.5mm for placebo-treated patients (treatment difference, -2.4mm [95% CI, -3.0, -1.8]; P <.01). Among patients who were proptosis responders at week 15, 71% maintained their response at week 52.
The THRIVE-2 trial enrolled 188 patients with moderate to severe chronic TED (onset greater than 15 months, any clinical activity score [0-7]), with 125 receiving veligrotug and 63 receiving placebo. The proptosis responder rate at week 15 was 57% for the veligrotug group and 8% for the placebo group (treatment difference, 49% [95% CI, 38-60]; P <.01). The mean change in proptosis from baseline was -2.4mm for veligrotug-treated patients and -0.5mm for placebo-treated patients (treatment difference, -1.9mm [95% CI, -2.4, -1.4]; P <.01). At week 52, 57% of patients who were proptosis responders at week 15 maintained their response.
In both trials, improvement in proptosis was observed as early as week 3, with continued improvement through week 15. Additionally, patients treated with veligrotug experienced improvements in diplopia (secondary endpoint) vs placebo at week 15.
- THRIVE (veligrotug [n=50]; placebo [n=26])
- Diplopia resolution: 49% vs 12% (treatment difference, 37.7% [95% CI, 18.9-56.6]; P <.01);
- Diplopia response: 59% vs 20% (treatment difference, 39.2% [95% CI, 18.8-59.6]; P <.01);
- Fifty percent of patients who achieved diplopia resolution maintained resolution at week 52.
- THRIVE-2 (veligrotug [n=65]; placebo [n=37])
- Diplopia resolution: 32% vs 14% (treatment difference, 17.7% [95% CI, 1.6-33.9]; P =.02);
- Diplopia response: 56% vs 25% (treatment difference, 30.9% [95% CI, 12.3-49.5]; P <.01);
- Eighty percent of patients who achieved diplopia resolution maintained resolution at week 52.
Similar reductions in proptosis and diplopia were observed when analyzing by age and sex and between smokers and nonsmokers
“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. This is an exciting new option for physicians to offer their TED patients.”
The most common adverse reactions reported with Lumvoa were muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension. The treatment may also exacerbate inflammatory bowel disease
Lumvoa is supplied as a 500mg/10mL solution in a single-doseed dosage is 10mg/kg administered by IV infusion every 3 weeks for a total of 5 infusions.
This article originally appeared on MPR
References:
- Viridian Therapeutics announces US FDA approval and launch of Lumvoa™(veligrotug-vvze) for the treatment of thyroid eye disease. News release. Viridian Therapeutics. June 26, 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.
- Lumvoa. Package insert. Viridian Therapeutics; 2026. Accessed June 29, 2026.https://www.viridiantherapeutics.com/wp-content/uploads/2026/06/Lumvoa-veligrotug-Final-USPI_26Jun2026.pdf.
