New Data Build on Growing Evidence Supporting TEPEZZA (teprotumumab-trbw) Efficacy in Thyroid Eye Disease (TED), Including in Patients With Less Severe Disease and Longer Disease Duration

Horizon Therapeutics plc (Nasdaq: HZNP) today announced new TEPEZZA (teprotumumab-trbw) data presented at the American Academy of Ophthalmology Annual Meeting (AAO 2020 Virtual), including findings suggesting benefits of TEPEZZA in the less severe eye of patients with Thyroid Eye Disease (TED), and new data from the OPTIC 48-week follow-up study and OPTIC-X clinical trial. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive and vision-threatening rare autoimmune disease.¹

“We continue to analyze our existing clinical trials and pursue new research to fully understand the impact TEPEZZA has on this challenging disease,” said Elizabeth H.Z. Thompson, Ph.D., group vice president, development and external search, Horizon. “Our data demonstrating the effect of TEPEZZA at varying stages of the disease, including in the less severely affected eye and in patients who have had Thyroid Eye Disease for a longer period of time, will help advance the science of Thyroid Eye Disease and instill greater understanding of the role TEPEZZA can play in improving patient outcomes.”

Compelling Response in Less Severe TED

Improvement in Fellow Eye of Patients with TED: Pooled Analyses from Teprotumumab Studies (PO305)

In patients with TED, one eye can have more severe symptoms than the other. The TEPEZZA Phase 2 clinical trial and OPTIC Phase 3 confirmatory clinical trial designated the more severely affected eye as the “study eye”.^2,3 This new analysis focused specifically on efficacy of TEPEZZA in treating the less severe eye, or “fellow eye”, of patients in the TEPEZZA Phase 2 and 3 trials. Researchers analyzed the intent-to-treat (ITT) population in the Phase 2 and Phase 3 studies, defined as all patients randomized to receive TEPEZZA (n=84) and all patients randomized to receive placebo (n=87). The fellow eye was less proptotic than the study eye in both the TEPEZZA (21.61 mm vs. 23.02 mm) and placebo (21.97 mm vs. 23.15 mm) groups, indicating less severe disease. Additionally, the fellow eye, on average, demonstrated less inflammation based on the clinical activity score (CAS) than the study eye in both the TEPEZZA (CAS: 4.3 vs. 5.1 points) and placebo (CAS: 4.7 vs. 5.3 points) groups.