Horizon Therapeutics announced today that study results highlight the success of its Tepezza infusion for treating thyroid eye disease.
Dublin, Ireland-based Horizon’s Tepezza proved in pooled Phase 2 and Phase 3 clinical trial data that it significantly improves proptosis (eye bulging) and diplopia (double vision) for TED patients in different subgroups, with most maintaining a long-term response, according to a news release.
Tepezza, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, is touted as the first and only medicine approved by the FDA for treating TED. It is delivered to patients via infusion.
Results, published in The Lancet Diabetes & Endocrinology, covered two 24-week, multicenter, double-masked, placebo-controlled clinical trials in which 84 patients were randomized to receive Tepezza and 87 received a placebo once every three weeks for a total of eight infusions.
Patients were analyzed for proptosis and diplopia and a posthoc analysis of a combined outcome measure, which calculated the percentage of patients with clinical improvement in one eye in at least two of the following: proptosis, diplopia, eyelid swelling, lid aperture, globe motility and clinical activity score.
Horizon found no evidence for acute disease rebound, observing 87% of patients responding to proptosis and 66% to diplopia, with 92% ophthalmic composite outcome observed seven weeks after the last Tepezza dose. The posthoc analysis indicated that 81% of Tepezza patients compared to 44% of placebo patients were responders at week 24.
At 51 weeks after the final dose, 67% responded to proptosis, 69% to diplopia and the composite outcome response came in at 83% .
“These comprehensive data enlighten our understanding of how Tepezza improves thyroid eye disease symptoms in both the short- and longer-term,” Horizon executive director of clinical development, ophthalmology Dr. Saba Sile said in the release. “We will apply these learnings as we continue to study Tepezza in the broader thyroid eye disease population and report findings in a larger, more diverse patient population in the future.”
