Thyroid eye disease (TED) is an autoimmune condition that causes swelling and inflammation of the eyes. TED is often associated with hyperthyroidism (an overactive thyroid gland) and Graves’ disease (an autoimmune condition that attacks the thyroid gland).
In TED, antibodies that attack the thyroid gland can also attack other tissues around the eyes. This may lead to bulging of the eyes (eyes that look like they are staring because your eyelids open wider than normal), double or reduced vision, red eyelids, and eye irritation. In rare cases, it may put pressure on the optic nerve, leading to vision loss or painful ulcers on the eye. These effects may be permanent if TED is not treated.
TED has two phases: active disease and inactive disease. Active disease is when inflammation causes symptoms to come and go. This can last for six months to a few years. Inactive disease is when the inflammation calms down.
Lumvoa (veligrotug-vvze) is an insulin-like growth factor-1 (IGF-1) receptor inhibitor used to treat TED. It can be used regardless of the disease activity or how long it has been present.
How Does Lumvoa Work for Thyroid Eye Disease?
TED happens when your immune system attacks the tissues around your eyes. A key driver of this process is a “receptor” (a docking site) on the cells behind your eye called the IGF-1 receptor. This acts like a switch that turns on swelling and inflammation. Lumvoa (veligrotug-vvze) is a medicine that blocks this IGF-1 receptor. This quiets the signals that tell those cells to swell and cause damage. By blocking this switch, Lumvoa seems to help reduce the eye bulging, inflammation, and other changes caused by the TED.
How Do I Use Lumvoa?
Lumvoa is a liquid that is infused into a vein once every three weeks for five infusions. These infusions are often given in a health care facility. However, sometimes it can be given in your home. Talk to your health care provider about which option may be best for you.
Certain people may have an infusion reaction (headache, fever, chills, tiredness, or increased blood pressure) during or shortly after a Lumvoa dose. If you have an infusion reaction with Lumvoa, your health care provider may give you certain medicines before your next infusion to lower the risk of these problems.
How Was Lumvoa Studied for Thyroid Eye Disease?
Researchers conducted two studies comparing Lumvoa to a placebo (which contains no medicine) in people with TED. One study used Lumvoa in people with active TED, while the other one involved people with chronic TED. In both studies, people were given infusions of Lumvoa 10 mg/kg every three weeks for five infusions. Neither the study participants nor the investigators knew who was receiving the medicine or a placebo.
There were a total of 301 adults in the two studies: 113 people had active disease, and 188 had chronic disease. In people with the active disease study, TED had started within the last 15 months. The clinical activity score (CAS) was 3 or greater (indicates active disease). The onset of TED in the people in the chronic disease study was 15 months or longer. CAS scores ranged from 0 to 7. People with prior orbital decompression surgery (a procedure that enlarges the eye socket) involving only the bone were permitted in either study.
People with an abnormal Pure Tone Average (PTA) hearing assessment (which measures how well you can hear sounds at different pitches and volumes), hearing loss, or other particular ear problems were not allowed in either study. People with inflammatory bowel disease were also not allowed in either study.
Below are some important characteristics of the study participants at the start of the studies.
Active Disease Study | Chronic Disease Study | |
|---|---|---|
| Median (middle) age | 50 years | 52 years old |
Eye bulging in millimeters (mm)
| 13.7 mm to 33.3 mm | 14.1 mm to 35 mm |
Double vision
| 67% | 54% |
What Were the Main Benefits Seen With Lumvoa?
In both studies, people treated with Lumvoa showed improvement in proptosis (eye bulging) at 15 weeks compared with those receiving a placebo. Improvement was defined as a reduction of at least 2 mm in eye bulging, without any increases in the unaffected eye.
In the active disease study, the average change in eye bulging at 15 weeks was -2.9 mm in people who received Lumvoa compared to -0.5 mm in those who received the placebo. In the chronic disease study, the average change in eye bulging at 15 weeks was -2.4 mm in people who received Lumvoa, compared to -0.5 mm in people who received the placebo.
Active Disease Study | Chronic Disease Study | |||
| Study Endpoints | Lumvoa | Placebo | Lumvoa | Placebo |
| Eye bulging improvement at 15 weeks | 70% | 5% | 57% | 8% |
| Double vision resolved at 15 weeks | 49% | 12% | 32% | 14% |
In both studies, there was significant improvement in eye bulging and double vision at week 15 in people who received Lumvoa compared to those who received the placebo.
Keep in mind that your results may differ from those seen in studies.
How Long Does It Take for Lumvoa to Work?
In both the active and chronic TED studies, at least some benefit in eye bulging was seen as early as three weeks after starting treatment. Improvements in double vision were seen as early as three weeks after starting treatment in the active TED study and as early as six weeks in the chronic TED study. These benefits continued over the course of the 15-week studies.
Keep in mind that your results may differ from those seen in studies.
How Long Do the Effects of Lumvoa Last?
Lumvoa is given as a total of five infusions, with one infusion every three weeks. The studies reviewed what happened from the beginning of treatment to the last infusion. These studies also looked at whether these benefits were maintained for one year after starting the medicine. You can see the results in the table below.
| Study Endpoints | Active Disease Study | Chronic Disease Study |
|---|---|---|
| Eye bulging still improved at 1 year (of those who were improved at week 15) | 71% | 57% |
| Double vision still resolved at 1 year (of those who were resolved at week 15) | 50% | 80% |
Many people who had improvements at week 15 were able to maintain those benefits for up to one year after the first dose.
Keep in mind that your results may differ from study results.
Is There Any Cost Assistance Available?
There is a support program offered by the drugmaker that may help you with Lumvoa costs. Your health care provider can help you get started. For questions or more information, you can call 1-866-822-7371, or you can visit www.lumvoa.com/resources.
