Drug Update · Ophthalmology

FDA Approves Veligrotug for Thyroid Eye Disease: 70% PRR in THRIVE

September 02, 2026

Approval date

June 26, 2026

Indication

Thyroid eye disease regardless of activity or duration

Primary efficacy

Proptosis responder rate 70% vs 5% (Week 15, THRIVE)

Recommended dose

10 mg/kg IV every 3 weeks for 5 infusions

Clinical Perspective

Ophthalmologists, oculoplastic surgeons, and clinicians managing adults with thyroid eye disease now have an FDA-approved systemic biologic therapy to treat proptosis and related signs and symptoms in adults with TED ^[3]^[4]^[1]. The THRIVE data support use of veligrotug to reduce proptosis and improve diplopia and disease activity measures after a 5-infusion course given over approximately 12 weeks ^[1]^[4]. How durable responses are beyond Week 52 and the long-term safety profile in broader clinical practice remain open questions?

Dr. Ravi Krishnan, MBBS, MS (Ophthalmology) · Ophthalmology

The FDA approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease on June 26, 2026. The approval was supported by the THRIVE Phase 3 program, in which veligrotug achieved a proptosis responder rate of 70% versus 5% with placebo at Week 15 in active thyroid eye disease (THRIVE) ^[2]^[1]^[6].

Clinical Context

Veligrotug (Lumvoa) is a humanized IgG1 monoclonal antibody that binds to the insulin-like growth factor-1 receptor (IGF-1R) and inhibits IGF-1R signaling; its mechanism in thyroid eye disease has not been fully characterized in the provided sources ^[4]^[5]. The product is manufactured and sponsored by Viridian Therapeutics and was approved as an intravenous injection in a 500 mg/10 mL vial formulation ^[2]^[3]^[4]. Clinicians should consult current prescribing information for full dosing guidance. The licensed indication is treatment of thyroid eye disease regardless of disease activity or duration as stated in the FDA approval documents and prescribing information ^[3]^[4]. The pivotal THRIVE study was a global, multicenter, randomized, double-masked, placebo-controlled phase 3 trial in adults with moderate-to-severe active thyroid eye disease; efficacy and safety were assessed through Week 52 in the trial report ^[1].

Key Findings

The THRIVE phase 3 trial showed veligrotug achieved a proptosis responder rate of 70% versus 5% with placebo at Week 15 as measured by Hertel exophthalmometry in patients with active thyroid eye disease ^[1]^[6].
In THRIVE, veligrotug also achieved an overall responder rate (ORR) of 67% versus 5% with placebo, and mean proptosis reduction by Hertel was 2.90 mm versus 0.48 mm for placebo at Week 15 ^[1].
Imaging-based PRR by MRI/CT was 71% versus 9% for placebo, diplopia improvement was 59% versus 20%, and diplopia resolution was 49% versus 12% at Week 15 in THRIVE ^[1].
Improvements were observed as early as Week 3 and responses showed durability through Week 52, with 70% of initial responders maintaining proptosis response at Week 52 in the trial report ^[1].

Safety & Tolerability

Infusion reactions have been reported and may include transient increases in blood pressure, fever, chills, headache, and fatigue; reported infusion reactions occurred in approximately 9% of patients in clinical trials ^[4].
Exacerbation of inflammatory bowel disease (IBD) has been reported; LUMVOA should be discontinued if IBD is suspected ^[4].
Hyperglycemia or increased blood glucose occurred in clinical trials; 12% of patients experienced hyperglycemia and patients with preexisting diabetes or impaired glucose tolerance require monitoring and control ^[4].
Hearing impairment including hearing loss, which in some cases may be severe or permanent, was identified as an adverse effect and patients’ hearing should be assessed before, during, and after treatment ^[4].
Most common adverse reactions (≥5%) included muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension ^[4].
Menstrual disorders were reported in approximately 29% of menstruating women treated with LUMVOA versus 6% with placebo in clinical trials ^[4].
In the THRIVE publication, the treatment discontinuation rate was 4%; most adverse events were mild and resolved with no serious treatment-related adverse events reported through Week 52 ^[1].

Study Design

THRIVE was a global, multicenter, randomized, double-masked, placebo-controlled Phase 3 trial of veligrotug in adults with moderate-to-severe active thyroid eye disease; the primary endpoint at Week 15 was the proptosis responder rate (≥2-mm reduction by Hertel exophthalmometry) or an overall responder rate depending on region ^[1]. In the active TED study, 75 patients received veligrotug and 38 received placebo; efficacy and safety were assessed through Week 52 in the published report ^[1]. The approved dosing regimen per the prescribing information is 10 mg/kg administered by intravenous infusion every three weeks for a total of 5 infusions ^[4]^[6]. Clinicians should consult current prescribing information for full dosing guidance. The FDA approved the biologics license application effective June 26, 2026 ^[2]^[3].

FAQ

What is veligrotug (Lumvoa) approved for?

Lumvoa (veligrotug-vvze) is approved for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration in adults. The approval is based on randomized, double-masked, placebo-controlled studies that evaluated reduction in proptosis and other signs and symptoms of TED. Lumvoa’s indication and approval date are provided in the FDA approval documents and prescribing information.

How does veligrotug work?

Veligrotug is a humanized IgG1 monoclonal antibody that binds to the insulin-like growth factor-1 receptor (IGF-1R) and inhibits IGF-1R signaling by blocking ligand-induced receptor autophosphorylation. The mechanism of action in thyroid eye disease has not been fully characterized in the provided source materials.

What is the recommended dose of veligrotug (Lumvoa)?

The recommended dosage of LUMVOA is 10 mg/kg administered by intravenous infusion every three weeks for a total of 5 infusions. Administer the first infusion over 45 minutes and, if well tolerated, subsequent infusions may be administered over a minimum of 30 minutes; do not administer as an IV push or bolus. See full prescribing information for dose preparation and administration instructions.

What are the most common side effects of veligrotug?

The most common adverse reactions reported at an incidence of 5% or more in clinical trials included muscle spasms, headache, hearing impairment (including tinnitus and hearing loss), hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension. Warnings and precautions include infusion reactions, potential exacerbation of inflammatory bowel disease, hyperglycemia monitoring, and hearing impairment including potential for permanent hearing loss.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Veligrotug for Thyroid Eye Disease: 70% PRR in THRIVE

Direct Clinical Takeaway & Evidence Summary

FDA Approves Veligrotug for Thyroid Eye Disease: 70% PRR in THRIVE

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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