Last year, the U.S. FDA approved Tepezza (teprotumumab) to treat thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards. What’s especially exciting about this new treatment is that it can spare some people from having to undergo surgery, as it’s the first and only prescription drug for the treatment of thyroid eye disease. A new study presented November 15 at AAO 2021, the 125th annual meeting of the American Academy of Ophthalmology, shows that even patients with mild inflammation can experience a reduction in eye bulging.
Thyroid eye disease is an immune system disorder that occurs at a rate of about 19 in 100,000 people per year. It can cause lots of symptoms, ranging from mild to serious, including redness in the whites of the eyes, irritation, pain and pressure in the eye, dry or watery eyes, light sensitivity, bulging eyes, misaligned eyes, and double vision. Though rare, it can also cause vision loss.
The disease begins with inflammation that causes the symptoms. As the disease progresses over time, the inflammation reduces or clears, but the pain, eye bulging, and double vision can persist.
Researchers wanted to see if Tepezza can reduce eye bulging in patients who had lower levels of inflammation compared with those who were evaluated in the two pivotal randomized trials on which the FDA granted approval for Tepezza.
They evaluated 15 patients who had a clinical activity score of 4 or less. After six months of treatment, 86.7 percent responded to treatment with a mean reduction in proptosis (eye bulging) of 2.9 ± 1.7 mm. Among patients with a clinical activity score of less than 3, 83.3 percent responded to treatment, with a mean reduction in proptosis of 2.6 ± 1.4 mm.
“We know from the Phase 2 and 3 clinical trials that Tepezza is effective in reducing proptosis in thyroid eye disease patients with high inflammatory activity and are pleased to see comparable efficacy in those with low-level inflammation,” said Raymond Douglas, MD, Ph.D., study investigator and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center. “This analysis is encouraging for physicians looking to prescribe Tepezza for patients who have little to no inflammatory activity but are still living with other devastating symptoms that affect their everyday lives.”