FDA approves Lumvoa, a new treatment for thyroid eye disease

The U.S. Food and Drug Administration approved Lumvoa, a new treatment for thyroid eye disease from Viridian. Lumvoa joins Tepezza as an FDA-approved treatment available for patients with TED, a rare lifelong autoimmune condition that affects the eyes and can worsen with time. Lumvoa’s approval means that TED patients and their doctors have multiple potential treatments at their disposal when deciding how to manage symptoms.

Thyroid eye disease can be active or inactive/chronic. Active TED typically lasts between six to eighteen months, with severe symptoms that sometimes need surgery. In the inactive or chronic phase that occurs later on, symptoms are less severe. Lumvoa is the first treatment approved for both active and chronic thyroid eye disease. It is also the first approved treatment to show a significant response in reducing and completely resolving double vision symptoms in active and chronic TED.

Lumvoa reduces TED symptoms

Lumvoa was tested in patients with both active and chronic TED. Most patients (70%) with active TED who were treated with Lumvoa experienced reduced eye bulging, which decreased by an average of 3.7 mm within 15 weeks of treatment during Phase 3 clinical trials. Lumvoa reduced double vision symptoms in more than half (59%) of patients and resolved double vision symptoms in nearly half (49%) of patients. Sixty-five percent of patients also experienced reduction of other TED-associated symptoms, such as pain and pressure, swelling or redness of eyelids, swelling of the covering of the whites of the eyes, inflammation of areas in the inner corner of the eye, eye bulging, decrease in eye movement limit, and reduced visual acuity.

Results were similar in a separate clinical trial of patients with inactive TED treated with Lumvoa: 57% reduced bulging eyes, 56% reduced double vision, 32% completely resolved double vision, and 55% reduced other TED-associated symptoms such as pain and redness.

How treatment for TED works

In people with TED, the body’s immune system mistakenly attacks the tissue behind the eyes, causing inflammation and swelling of the muscle and fat behind the eye. This can lead to eye bulging, redness, and watery eyes, among other symptoms, and can cause vision loss if left untreated.  

Tepezza and Lumvoa – the two currently available treatments specifically for TED – both work by blocking a protein called IGF-1R that contributes to inflammation behind the eyes, although the exact way the treatment works is not yet fully understood.

Potential side effects of TED treatments

There are potential side effects and risks to taking Lumvoa. The treatment, which is delivered as five IV infusions over 12 weeks, led to infusion reactions in 9% of patients. Lumvoa also has the potential to cause permanent, severe hearing impairment or loss. Fifteen percent of patients experienced hearing impairment, including ringing in the ears, hearing loss, deafness, and abnormal amplification of their own voice.

Menstrual disorders were reported in about 29% of menstruating women treated with Lumvoa compared to 6% of patients treated with placebo in clinical trials. Women who may become pregnant should use appropriate forms of contraception during treatment.

Lumvoa can exacerbate irritable bowel disease (IBD) in people who have the condition, and trigger IBD in some people who do not have it prior to using Lumvoa.  

Side effects are similar for Tepezza, the other FDA-approved TED medication.

Talk to your provider about treatment options

People with TED should talk to their doctors about management and treatment options, which are quickly changing.

Viridian, the maker of Lumvoa, is also planning to submit a biologics license application early in 2027 for a separate TED treatment called elegrobart, which functions in much the same way as Lumvoa but is a subcutaneous injection. In addition, enspryng, an at-home, subcutaneous injection treatment for TED from Genentech, was recently granted priority review from the FDA. The FDA should make a decision by October 2026.

Visit the Foundation’s Thyroid Eye Disease resource page for more information on symptoms, diagnosis, and other potential treatments making their way through the clinical pipeline.