FDA Approves Viridian's Lumvoa (veligrotug-vvze) as First Therapy Labeled for Both Active and Chronic Thyroid Eye Disease

FDA Approves Viridian's Lumvoa (veligrotug-vvze) as First Therapy Labeled for Both Active and Chronic Thyroid Eye Disease

On June 26, 2026, the U.S. FDA approved Viridian Therapeutics' Lumvoa (veligrotug-vvze), an intravenous insulin-like growth factor-1 receptor (IGF-1R) full antagonist, for the treatment of Thyroid Eye Disease (TED).

Lumvoa's approval marks a historic first: it is the first TED treatment approved with labeling that covers patients regardless of disease activity or duration, encompassing both active and chronic phases of the disease. This broad label positions Lumvoa as a direct, highly competitive challenger to Amgen's blockbuster IGF-1R inhibitor Tepezza (teprotumumab-trbw), which originally launched with labeling restricted to active TED.¹

Pivotal Phase 3 Evidence

The FDA granted Lumvoa Priority Review and Breakthrough Therapy Designation. The approval was supported by two large-scale Phase 3 trials:

1. THRIVE (Active TED): Met its primary and all secondary endpoints at week 15, demonstrating statistically significant reductions in proptosis (eye bulging) and improvements in diplopia (double vision).
2. THRIVE-2 (Chronic TED): Demonstrated clinical efficacy in patients with chronic, long-standing disease, mirroring the rapid onset of benefit seen in active disease.

Key Differentiators and Efficacy Highlights

• Treatment Burden: Lumvoa is administered as a 12-week course consisting of five intravenous infusions given once every three weeks. This is a significantly reduced treatment duration compared to Tepezza's standard eight-infusion regimen, lowering the therapeutic burden for patients.
• Rapid Onset: Reductions in proptosis were observed as early as three weeks into treatment.
• Diplopia Resolution: Lumvoa is the first approved product to demonstrate a statistically significant effect in both diplopia response and complete resolution of double vision in both active and chronic cohorts.
• Safety Concerns: Like other IGF-1R inhibitors, Lumvoa carries warnings for infusion reactions (reported in ~9% of patients), potential exacerbation of Inflammatory Bowel Disease (IBD), hyperglycemia (12% of patients), and hearing impairment/hearing loss, which can be permanent in some cases. Pre- and post-treatment hearing evaluations are recommended.

"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. 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." — Michael Yen, M.D., Professor of Oculoplastic Surgery and Ophthalmology at Baylor College of Medicine

Viridian has launched Lumvoa immediately, supported by its patient assistance program, ViridianCares™. The approval represents Viridian's first commercial product, with a subcutaneous formulation of its next-generation antibody elegrobart currently on track for a BLA submission in Q1 2027.