WASHINGTON, Jan. 22 (Xinhua/APP):The U.S. Food and Drug Administration (FDA) has approved the first treatment for thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed.
FDA approved Tepezza for the treatment of adults with thyroid eye disease that caused the patients’ eyes to be pushed forward and bulge outwards. Currently, there are very limited treatment options for this potentially debilitating disease.
“This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non-surgical treatment option,” said Wiley Chambers, deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research.
Thyroid eye disease is associated with the outward bulging of the eye that can cause eye pain, double vision, light sensitivity or difficulty in closing the eye. Tepezza was approved based on the results of two clinical studies consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo.
Of those patients who were administered Tepezza, 71 percent in one study and 83 percent in the other demonstrated a greater than 2 millimeter reduction in eye protrusion as compared to 20 percent and 10 percent of subjects who received placebo, respectively.
