The drug, Tepezza (teprotumumab-trbw), was approved on Tuesday based on the results of two studies consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo.
‘Thyroid eye disease is linked to the outward bulging of the eye that can cause a variety of symptoms like eye pain, double vision, light sensitivity, or difficulty closing the eye.
Of the patients who were administered Tepezza, 71 percent in Study one and 83 percent in Study two demonstrated a greater than two-millimeter reduction in eye protrusion as compared to 20 percent and 10 percent of subjects who received placebo, respectively.
"Today's approval marks an important milestone for the treatment of thyroid eye disease. Currently, there are very limited treatment options for this potentially debilitating disease," said Wiley Chambers, Deputy Director of the Division of Transplant and Ophthalmology Products in the FDA's Centre for Drug Evaluation and Research.
"This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, nonsurgical treatment option," Chambers said.
Although this condition impacts relatively few individuals, thyroid eye disease can be incapacitating.
For example, the troubling ocular symptoms can lead to the progressive inability of people with thyroid eye disease to perform important daily activities, such as driving or working.