Lumvoa

Lumvoa is used to treat thyroid eye disease (TED), regardless of TED disease activity or duration. It is given by intravenous infusion once every three weeks for a total of five infusions.

Lumvoa (veligrotug-vvze) is an insulin-like growth factor-1 receptor (IGF-1R) inhibitor. In TED, IGF-1R is overexpressed on orbital fibroblasts, connective tissue cells in the eye socket. Overactivation of these cells drives tissue expansion that pushes the eye forward (proptosis) and restricts eye movement (diplopia). Veligrotug-vvze blocks IGF-1R signaling by inhibiting receptor autophosphorylation, reducing this abnormal fibroblast activity, though its precise mechanism in TED has not been fully characterized.

Lumvoa (veligrotug-vvze) received FDA approval on June 26, 2026, and is manufactured by Viridian Therapeutics, Inc.

Lumvoa was evaluated in two randomized, double-masked, placebo-controlled clinical trials in 301 patients with thyroid eye disease: Study 1 (THRIVE: NCT05176639) enrolled 113 patients with and without active TED, and Study 2 (THRIVE-2: NCT06021054) enrolled 188 patients with chronic TED.

• Patients received Lumvoa 10 mg/kg or placebo intravenously every 3 weeks for 5 infusions.
• At week 15, proptosis responder rates were 70% vs 5% (Lumvoa vs placebo) in Study 1 and 57% vs 8% in Study 2.
• Diplopia response rates were 59% vs 20% and 56% vs 25%, respectively.
• Improvement in proptosis was observed as early as 3 weeks in both studies.

Lumvoa is administered via intravenous (IV) infusion by a healthcare professional.

Before receiving Lumvoa, tell your healthcare provider about all your medical conditions including if you:

• have diabetes or impaired glucose tolerance
• a history of inflammatory bowel disease (IBD)
• are pregnant, planning to become pregnant, or breastfeeding.

A baseline hearing assessment is required before treatment begins.

Pregnancy

Lumvoa may harm an unborn baby and should not be used during pregnancy. Females of reproductive potential should use effective contraception before initiation, throughout treatment, and for 6 months after the last dose. A pregnancy test is required before starting treatment. If pregnancy occurs during treatment, Lumvoa should be discontinued.

Breastfeeding

There are no data on the presence of Lumvoa in human milk, its effects on the breastfed infant, or its effects on milk production.

Common side effects

The most common side effects of Lumvoa are:

• muscle spasms
• headache
• hearing impairment
• hyperglycemia (high blood sugar levels)
• fatigue
• diarrhea
• ear discomfort
• infusion-related reactions
• nausea
• nasopharyngitis
• increased blood creatine phosphokinase levels
• dry skin
• hypertension (high blood pressure).

In addition, menstrual disorders (amenorrhea, irregular menstruation, dysmenorrhea, delayed menstruation, intermenstrual bleeding, and other menstrual disorders) were reported in approximately 29% of menstruating women treated with Lumvoa in clinical trials.

Warnings and precautions

Lumvoa can cause the following serious side effects:

• Infusion reactions. Lumvoa may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with Lumvoa. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, fever, chills, headache, and fatigue. Infusion reactions may occur during or soon after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids, antihistamines, and antipyretics. If you experience an infusion reaction, your healthcare provider will consider premedications and/or administering the infusion at a slower infusion rate.
• Inflammatory bowel disease. Lumvoa may cause exacerbation of inflammatory bowel disease (IBD). IBD has been reported in patients receiving IGF-1R inhibitors without a prior diagnosis of IBD. Your healthcare provider will monitor you for signs and symptoms of IBD, including those with no prior history. If IBD is suspected, discontinue use of Lumvoa.
• Hyperglycemia. Hyperglycemia, or elevated blood glucose, may occur in patients treated with Lumvoa. In clinical trials, 12% of patients, of whom one-half had preexisting diabetes or impaired glucose tolerance, experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Your healthcare provider will assess you for elevated blood glucose and symptoms of hyperglycemia before your infusion and continue to monitor you while you are on treatment with Lumvoa. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving Lumvoa. Continued monitoring after treatment is recommended for patients who experience hyperglycemia while on Lumvoa.
• Hearing impairment, including hearing loss. Lumvoa may cause severe hearing impairment, including hearing loss, which may be permanent in some cases. Your healthcare provider will assess your hearing before, during, and after treatment and discuss the benefits and risks.

See the Lumvoa Prescribing Information for a complete list of side effects. To report suspected adverse reactions, contact Viridian Therapeutics, Inc. at 1-866-321-VRDN (1-866-321-8736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dose of Lumvoa for TED

• 10 mg/kg intravenously every 3 weeks for a total of 5 infusions (approximately 3 months of treatment)
• The first infusion is given over 45 minutes.
• If well tolerated, subsequent infusions may be given over a minimum of 30 minutes.
• Lumvoa must not be given as an IV push or bolus injection or infused concomitantly with other agents.

No drug interaction studies have been conducted with Lumvoa.

Active ingredients: veligrotug-vvze

Inactive ingredients: histidine (6.50 mg), L-histidine hydrochloride monohydrate (33.1 mg), methionine(14.9 mg), Polysorbate 80 (2.0 mg), sucrose (800 mg), and Water for Injection (quantity sufficient to 10 mL).

The final concentration is 50 mg/mL with a pH of 5.5.

Lumvoa (veligrotug-vvze) injection is supplied as a sterile, preservative-free, yellowish to brown, slightly opalescent solution: 500 mg/10 mL (50 mg/mL) single-dose vial (NDC 85166-001-01).