What is Lumvoa?
Lumvoa is a prescription medicine used to treat thyroid eye disease, also known as TED. Lumvoa can help relieve symptoms in people who are newly diagnosed or have been living with TED for a long time.
How Lumvoa works
Lumvoa's mechanism of action is not fully understood, and is based on laboratory studies.
In TED, the body's immune system mistakenly attacks the muscle and fat tissue around the eyes. This can cause swelling, inflammation, and a buildup of tissue around the eyes
Lumvoa is designed to block signals on cells that play an important role in driving the inflammation and tissue changes seen in TED
By blocking this signal, inflammation and swelling behind the eyes may decrease and improve symptoms
Lumvoa was studied in a range of people with TED
This included people recently diagnosed with TED as well as those who were living with TED for a long time.
301 people with TED
Included both:
113 people recently diagnosed (active TED)
188 people long-term (chronic TED)
Treatment over 12 weeks
People received a total of 5 infusions of Lumvoa over 12 weeks.
Some people received a placebo (salt water) infusion on the same schedule for comparison
What doctors looked at:
Eye bulging (primary measurement)
Double vision (secondary measurement)
Impact on daily living and feelings about appearance (exploratory measurements: not the main focus of the study)
Lumvoa provides relief of TED symptoms
Whether you've been recently diagnosed or have had TED for years, treatment with Lumvoa may help reduce your symptoms.
If you have been diagnosed within the last 15 months, see the results for active TED below.
If you were diagnosed more than 15 months ago, see the results for chronic TED below.
Visible improvements in eye bulging and double vision
The primary measurement of the study: how does Lumvoa affect eye bulging (proptosis)?
Less eye bulging (proptosis)
In active TED, improvement of eye bulging was seen at Week 15
70%
of people taking Lumvoa had reduced eye bulging at 15 weeks vs 5% with placebo*
(Lumvoa n=75 Placebo n=38)
Some people saw improvement of eye bulging as early as Week 3
About 70% of people who had reduced eye bulging at 15 weeks maintained their improvement at 52 weeks
A secondary measurement of the study: how does Lumvoa affect double vision (diplopia)?
Improvement in double vision (diplopia)†
59%
of people taking Lumvoa experienced improvement in double vision at 15 weeks vs 20% with placebo
(Lumvoa n=50 Placebo n=26)
Double vision completely went away at 15 weeks in
49%
of people taking Lumvoa vs 12% with placebo
50% of people who experienced resolution at 15 weeks maintained their results at 52 weeks
Double vision went away as early as 3 weeks in some people taking Lumvoa
Real results
In clinical trials, people taking Lumvoa experienced noticeable improvement in eye bulging (proptosis) and double vision (diplopia) at 15 weeks.
Eye bulging: 27 mm
Double vision: Occasional
Eye bulging: 22.5mm after treatment
Double vision: Resolved
Following treatment with Lumvoa
On average, people who took Lumvoa and who had a response reduced their eye bulging at Week 15 by 3.7 mm
Not all patients treated with Lumvoa showed this much improvement. Written consent for these participant images was provided to the investigator (V.L.), courtesy of Imperial College Healthcare NHS Trust UK and Viridian Therapeutics, Inc. Individual results may vary
At 15 weeks, people taking Lumvoa reported in a survey overall improvement in visual function and appearance
This analysis was exploratory, meaning it was done to learn more, not to make firm conclusions about how the treatment works.
Visual Function
Includes activities such as driving, reading, watching TV, walking, biking, moving around the house and hobbies.
Appearance
How people feel about their appearance, confidence and social interactions.
These measures were determined through the Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire, which contains 8 questions on visual functioning and 8 questions on appearance.
This questionnaire was used to better understand patient experience, but it was not specifically designed or validated for TED, so the results should be interpreted with caution.
Measurements were gathered in 75 people taking Lumvoa and 38 people taking a placebo (a salt water infusion not containing medicine).
*Change in eye bulging was measured at week 15. A patient was considered a responder if the treated eye had a 2-mm improvement compared with the start of the study and the other eye did not worsen.
†Improvement in double vision was measured using a 4-point scale where scores ranged from 0 (no double vision) to 3 (constant double vision). Patients were considered responders if their double vision improved by 1 point from the start of the study by Week 15. Complete resolution meant that patients who had double vision at the start of the study reported no double vision at Week 15.
‡This exploratory analysis of 75 people taking Lumvoa and 38 people taking placebo examined additional patient‑reported information from participants who completed the Graves’ Ophthalmopathy Quality of Life (GO‑QOL) questionnaire, a 16-question survey used to track how you feel about the effect thyroid eye disease has on daily vision and physical appearance. It hasn't been officially "validated" (proven to be fully accurate) for all patients with TED. Because of this, the results should be viewed as a general guide rather than an exact measurement. An 8‑point change on the questionnaire represents a meaningful improvement that patients are likely to notice. Because this was not the main goal of the study, the results are not supportable with the highest level of confidence, and should be interpreted with caution.
Demonstrated results for chronic TED
The primary measurement of the study: how does Lumvoa affect eye bulging (proptosis)?
Less Eye Bulging (proptosis)
In chronic TED, improvement of eye bulging was seen at Week 15
57%
of people taking Lumvoa had reduced eye bulging at 15 weeks vs 8% with placebo*
(Lumvoa n=125 Placebo n=63)
Some people saw improvement of eye bulging as early as Week 3
About 57% of people who had reduced eye bulging at 15 weeks maintained their improvement at 52 weeks
A secondary measurement of the study: how does Lumvoa affect double vision (diplopia)?
Improvement in Double Vision (diplopia)†
56%
of people taking Lumvoa experienced improvement in double vision at 15 weeks vs 25% with placebo
(Lumvoa n=65 Placebo n=37)
Double vision completely went away at 15 weeks in
32%
of people taking Lumvoa vs 14% with placebo
80% of people who experienced resolution at 15 weeks maintained their results at 52 weeks
Double vision went away as early as 3 weeks with some people taking Lumvoa
At 15 weeks, people taking Lumvoa reported in a survey overall improvement in visual function and appearance
This analysis was exploratory, meaning it was done to learn more, not to make firm conclusions about how the treatment works.
Visual Function
People taking Lumvoa reported improvement in driving, reading, watching TV, walking, biking, moving around the house and hobbies.
Appearance
People taking Lumvoa reported improvement in how they feel about their appearance, confidence, and social interactions.
These measures were determined through the Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire, which contains 8 questions on visual functioning and 8 questions on appearance.
This questionnaire was used to better understand patient experience, but it was not specifically designed or validated for TED, so the results should be interpreted with caution.
Measurements were gathered in 125 people taking Lumvoa and 63 people taking a placebo (a salt water infusion not containing medicine).
*Change in eye bulging was measured at week 15. A patient was considered a responder if the treated eye had a 2-mm improvement compared with the start of the study and the other eye did not worsen.
†Improvement in double vision was measured using a 4-point scale where scores ranged from 0 (no double vision) to 3 (constant double vision). Patients were considered responders if their double vision improved by 1 point from the start of the study by Week 15. Complete resolution meant that patients who had double vision at the start of the study reported no double vision at Week 15.
‡This exploratory part of the study involved 125 people who took Lumvoa and 63 people who took placebo, and it examined additional patient‑reported information from participants who completed the Graves’ Ophthalmopathy Quality of Life (GO‑QOL) questionnaire. The survey included questions about daily activities, appearance, and social experiences affected by thyroid eye disease. An 8‑point change on the questionnaire represents a meaningful improvement that patients are likely to notice. Because this was not the main goal of the study, the results are not supportable with the highest level of confidence, and should be interpreted with caution.
Potential side effects of Lumvoa
The most common side effects (occurring in 5% or more of patients) were:
Muscle spasms
Headache
Hearing problems
High blood sugar
Tiredness
Diarrhea
Ear discomfort
Infusion reactions
Nausea
Cold-like symptoms
Increased blood creatine phosphokinase (CPK)
Dry skin
High blood pressure
In clinical studies, most patients (94%) completed all 5 infusions of Lumvoa.
Most side effects were mild or moderate and got better during or after treatment.
Menstrual changes (such as irregular or missed periods) were reported in about 29% of menstruating women who took Lumvoa, compared to 6% with placebo.
Lumvoa may cause hearing problems, including hearing loss. In some cases, hearing loss may be permanent. In clinical studies, most hearing-related events were mild, and most got better during or after treatment. Your doctor should check your hearing before, during, and after treatment.
Talk to your doctor if you are experiencing any side effects while on Lumvoa. These may not be all of the possible side effects of Lumova.
How is Lumvoa given?
A full course of Lumvoa is 5 infusions given 3 weeks apart over 12 weeks.
During an infusion, medicine is delivered directly into your bloodstream through a needle placed in a vein—usually in your arm—that is connected to a small tube. Intravenous (IV) infusions are a common way doctors treat autoimmune and inflammatory conditions like TED.
Your first infusion will take about 45 minutes. If well tolerated, the remaining infusions take about 30 minutes each.