FDA greenlights Lumvoa for thyroid eye disease

On June 26, 2026, FDA approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), a rare autoimmune disease involving inflammation and tissue remodeling around and behind the eyes. TED can cause proptosis, diplopia, pain, and vision impairment, with substantial effects on daily functioning and quality of life.

Lumvoa is a full antagonist of insulin-like growth factor-1 receptor (IGF-1R) and is indicated for TED regardless of disease activity or duration. Viridian said it is the first approved TED treatment with labeling that includes data from both active and chronic disease.

That may be useful in practice because TED treatment decisions often depend on disease phase, and some patients continue to have burdensome proptosis or diplopia after the active inflammatory period.

The approval was supported by two pivotal phase 3 trials: THRIVE in active TED and THRIVE-2 in chronic TED. Both trials met their primary and secondary endpoints, with statistically significant and clinically meaningful improvements at week 15 across key TED signs and symptoms, according to Viridian.

Across the trials, Lumvoa was given as a 12-week course consisting of five IV infusions administered every three weeks. Viridian reported reductions in proptosis as early as three weeks. The company also said Lumvoa is the first approved TED product to show a statistically significant effect on both diplopia response and complete resolution of diplopia in active and chronic TED.

For clinicians, the practical value is a treatment option with evidence across the TED spectrum and outcome data tied to symptoms patients often find most disruptive, including eye bulging and double vision. Lumvoa is given as five IV infusions over 12 weeks, giving clinicians a defined treatment course to discuss when weighing infusion burden, access, symptom severity, and patient preference.

Safety considerations include infusion reactions, hearing impairment including hearing loss, hyperglycemia, and possible inflammatory bowel disease exacerbation. Hearing should be assessed before, during, and after treatment; glucose should be assessed before infusion and monitored during therapy. Lumvoa should be discontinued if IBD is suspected.

The most common adverse reactions included muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, increased blood creatine phosphokinase, dry skin, and hypertension.

“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. This is an exciting new option for physicians to offer their TED patients,” said Michael Yen, MD, professor of oculoplastic surgery and ophthalmology at Baylor College of Medicine and an investigator in the THRIVE program.

Source: Viridian Therapeutics. 2026 June 26. Viridian Therapeutics announces US FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease