This week the FDA announced the approval of the first medication to treat thyroid eye disease. The treatment reduces the characteristic bulging eyes. Following FDA approval, the treatment will soon be available across the U.S.
Tepezza (formerly known as Teprotumumab) is a fully human monoclonal antibody inhibitor of insulin-like growth factor-1 (IGF-1R) that works by binding to IGF-1R/TSHR signaling complexes, blocking the auto-antibodies from attacking the orbital cells. As a result, the drug reduces the eye swelling characteristic of thyroid eye disease. The drug is administered via intravenous therapy (IV), with eight infusions over a six month period. Each infusion can take between an hour to an hour and a half.
The FDA granted the approval of Tepezza to Horizon Therapeutics Ireland DAC.
Patient - Pre-Treatment (1)
The approval comes following results from two studies consisting of 170 patients with thyroid eye disease. Results showed that patients administered Tepezza had a greater reduction in their eye protrusion compared to those who received the placebo. Dr. Raymond Douglas, an oculoplastic surgeon who was involved in both the studies, explained that the results were dramatic.
“I have to say that it’s really been a remarkable improvement for patients,” Douglas told Forbes. “It’s amazing how life-transforming this has been for patients. They are back to normal and do not have to worry about losing their vision, getting double vision, or other things that come with this disease such as eye-bulging and facial disfigurement.”
Thyroid eye disease is a condition where the muscle and fatty tissue behind the eye become inflamed and cause the eyes to bulge. It is an autoimmune disease, and until now the only treatment was to wait until the inflammation died down and then use surgical options to lessen the eye-bulging. However, sometimes it can take years for the inflammation to die down, and in that time patients are left dealing with life-altering disease symptoms.
Patient - Post-Treatment (1)
“The patients’ eyes get dry and that leads to the inability to close their eyes,” explained Tim Walbert, CEO of Horizon. “Patients will tell you that trying to close their eyelids is like scratching sandpaper on their eye.”
Other symptoms include ulcers on the eye, light sensitivity, double vision and also misalignment of the eye. In some cases, the bulging can put pressure on the optic nerve and cause blindness.
“You can imagine the impact on quality of life is dramatic,” Walbert told Forbes. “Activities of daily living that we take for granted, such as reading or driving, become difficult. You ultimately may become fully dependent on family.”
Walbert explained that Horizon is currently working to set up an infusion site-of care referral process for treating physicians that may not have infusion capabilities.
