Positive topline data from phase III clinical trial (OPTIC-J) in Japan evaluating Tepezza for the treatment of active thyroid eye disease .- Horizon Therapeutics

TED is a serious, progressive, debilitating and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.

“The positive topline results from this trial are important because there are no approved medicines in Japan for Thyroid Eye Disease, resulting in a significant unmet need for patients who are struggling with the physical symptoms of the disease as well as the emotional and social burden that is associated with it,” said Yuji Hiromatsu, M.D., professor emeritus, Kurume University Medical Center and co-coordinating trial investigator. “Currently, the only treatment options in Japan are steroids and multiple invasive surgeries. Tepezza would offer patients a non-surgical option that not only treats the symptoms, such as proptosis and diplopia, but targets the underlying mechanism of the disease.”

Topline data demonstrated that the primary endpoint was met. At Week 24, 89% of patients treated with Tepezza had a clinically meaningful improvement in proptosis ( greater than 2 mm) compared with placebo (11%) (p<0.0001). the safety profile is consistent with what was observed in previous clinical trials of tepezza. additional data from the trial will be presented at a medical congress and published in a peer-reviewed medical journal.></0.0001).>