Lumvoa (veligrotug-vvze): FDA approval, pivotal trial and safety
Approved
Type
Therapeutic biologic · Intravenous
FDA-approved use
To treat thyroid eye diseaseWording from FDA's list of novel approvals.
FDA review
Priority review
Company
Viridian Therapeutics
Application
BLA 761530
Specialty
Endocrinology, Ophthalmology
At a glance
Lumvoa (veligrotug-vvze) is an IGF-1R inhibitor approved in June 2026 for thyroid eye disease, whatever the disease activity or duration. In the label's active-disease study (Study 1), 70% of patients on Lumvoa had a proptosis response at Week 15 versus 5% on placebo (difference 65%, 95% CI 52 to 78). The main safety points are hearing impairment, hyperglycemia, infusion reactions and possible inflammatory bowel disease.
What it is and how it works
Veligrotug-vvze is a humanized IgG1 monoclonal antibody that binds the insulin-like growth factor-1 receptor (IGF-1R). It blocks ligand-induced receptor autophosphorylation and so inhibits IGF-1R signaling. The label says its mechanism in thyroid eye disease has not been fully characterized. It is given as an intravenous infusion. The label does not restrict use by disease activity or duration, and it covers both active and chronic disease.
Randomized, double-masked, placebo-controlled trial. Patients were randomized 2:1 and received intravenous infusions every 3 weeks for 5 infusions.
Patients
113 adults with active thyroid eye disease of onset within 15 months and a clinical activity score of 3 or more; 75 received Lumvoa and 38 placebo. Median age was 50 years and 77% were female. 67% had diplopia at baseline.
Compared with
Placebo
Primary endpoint
Proptosis responder rate at Week 15: at least a 2 mm reduction in proptosis in the study eye, without a 2 mm or greater worsening in the other eye.
Result
70% with Lumvoa versus 5% with placebo; difference 65% (95% CI 52 to 78). MRI/CT measurements gave similar results.
Other results
The label also evaluated diplopia, pain, eyelid and conjunctival signs, clinical activity score and quality of life. The excerpt gives no numbers for these.
Safety in the trial
Pooled with Study 2, the safety population was 200 on Lumvoa and 101 on placebo, and 94% of Lumvoa patients completed 5 infusions. Common reactions included hearing impairment, hyperglycemia, and infusion reactions.
How does Lumvoa (veligrotug-vvze) compare with the alternatives (Teprotumumab, Intravenous methylprednisolone, Orbital radiotherapy) for thyroid eye disease? Summarize head-to-head and indirect evidence, efficacy, safety and where each fits, with citations.
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Randomized, double-masked, placebo-controlled trial. Patients were randomized 2:1 and received intravenous infusions every 3 weeks for 5 infusions.
Patients
188 adults with thyroid eye disease of onset more than 15 months earlier and any clinical activity score; 125 received Lumvoa and 63 placebo. Median age was 52 years and 75% were female. 54% had diplopia at baseline.
Compared with
Placebo
Primary endpoint
Proptosis responder rate at Week 15, defined as in Study 1.
Result
The label excerpt does not give the Study 2 results.
Other results
Not given in the excerpt.
Safety in the trial
Safety was pooled with Study 1. Menstrual disorders were more frequent with Lumvoa than placebo among menstruating women.
There is no boxed warning. The label warns of infusion reactions, reported in about 9% of patients and usually mild or moderate. It also warns of IBD exacerbation or new IBD, so patients should be monitored and treatment stopped if IBD is suspected. Hyperglycemia occurred in 12% of trial patients, and half of them had preexisting diabetes or impaired glucose tolerance. Lumvoa may cause severe hearing impairment, sometimes permanent, so hearing should be assessed before, during and after treatment. Menstrual disorders were reported in about 29% of menstruating women on Lumvoa (24/82) versus 6% on placebo (2/33). Other common reactions were muscle spasms, headache, fatigue and diarrhea.
What it competes with
Thyroid eye disease is managed with selenium, local measures and, for active disease, intravenous glucocorticoids. Targeted biologics and surgery are used for moderate to severe or sight-threatening disease.
TeprotumumabAnother IGF-1R inhibitor given by infusion. It carries similar hearing and glucose warnings.
Intravenous methylprednisoloneStandard first-line anti-inflammatory therapy for moderate to severe active disease. It has limited effect on proptosis and carries steroid-related risks.
Orbital radiotherapySometimes added for active disease with motility problems, usually alongside glucocorticoids.
Orbital decompression surgeryUsed for persistent proptosis or sight-threatening disease, and for rehabilitation in chronic disease.
SeleniumA supplement sometimes used in mild disease.
Bottom line for clinicians
Lumvoa offers an IGF-1R option that was studied in both active and chronic thyroid eye disease. Weigh the benefit against hearing risk, and obtain baseline audiometry and follow hearing during treatment. Check glucose control, especially in patients with diabetes, and use caution in patients with IBD.
Dosing, contraindications and full warnings are in the prescribing information.
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Last updated October 28, 2026 by 2 Minute Medicine.
For healthcare professionals. A summary of public FDA documents and published trials, not medical advice. Check the full prescribing information before prescribing.
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