Local time June 26, 2026, Viridian Therapeutics, Inc., a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines in autoimmune and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED). TED is a rare, disabling autoimmune disease characterized by inflammation and remodeling of orbital and retro-orbital tissues, which can lead to proptosis, diplopia, pain, and visual impairment.
The label for Lumvoa (veligrotug-vvze) includes clinical data from both active and chronic TED. In two pivotal Phase III trials, Lumvoa treatment demonstrated rapid, sustained, and consistent improvements in key signs and symptoms of active and chronic TED. Lumvoa is also the first approved TED therapy to achieve statistically significant effects on both diplopia response and complete diplopia resolution in active and chronic disease.
Basis of Approval: Pivotal THRIVE and THRIVE-2 Clinical Trials
Lumvoa received FDA Priority Review designation, and its approval was based on the THRIVE study in active TED and the THRIVE-2 pivotal Phase III trial in chronic TED. Both trials met their primary endpoints and all secondary endpoints, demonstrating consistent, statistically significant, and clinically meaningful improvements in all key TED signs and symptoms at Week 15.
In both trials, patients received a 12-week course of Lumvoa designed to reduce treatment burden. Lumvoa showed rapid onset of clinical benefit, with reductions in proptosis observed as early as Week 3. Lumvoa is the first approved product to show statistically significant effects on diplopia response and complete resolution in both active and chronic TED. The FDA granted Lumvoa Breakthrough Therapy Designation and Priority Review.
Important Safety Information
Infusion Reactions
Lumvoa may cause infusion reactions, reported in approximately 9% of patients. Signs and symptoms include transient blood pressure elevation, pyrexia, chills, headache, and fatigue. Infusion reactions may occur during or shortly after infusion. Reported infusion reactions were generally mild to moderate and successfully managed with glucocorticoids, antihistamines, and antipyretics. For patients experiencing infusion reactions, consider standard premedication and/or slowing the infusion rate.
Inflammatory Bowel Disease
Lumvoa may cause exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients treated with insulin-like growth factor-1 receptor inhibitors, including those without a prior IBD diagnosis. Monitor patients, including those without a history of IBD, for signs and symptoms of IBD. If IBD is suspected, discontinue Lumvoa.
Hyperglycemia
Hyperglycemia or elevated blood glucose may occur in patients treated with Lumvoa. In clinical trials, 12% of patients experienced hyperglycemia, half of whom had pre-existing diabetes or glucose intolerance. Hyperglycemic events should be managed with glucose-lowering medications as needed. Assess patients for elevated blood glucose and hyperglycemic symptoms before infusion and monitor during treatment. Ensure adequate glycemic control in patients with hyperglycemia or pre-existing diabetes before and during Lumvoa treatment. For patients who develop hyperglycemia during treatment, continue monitoring after drug discontinuation.
Hearing Impairment (Including Hearing Loss)
Lumvoa may cause severe hearing impairment, including hearing loss, which may be permanent in some cases. Assess hearing in patients before, during, and after Lumvoa treatment, and weigh the benefit-risk profile for each patient.
Most Common Adverse Events
The most common adverse reactions (incidence ≥5%) were muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reactions, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension.
Females of Reproductive Potential
Appropriate contraception should be used before starting Lumvoa, during treatment, and for 6 months after the last dose.
