The company announced positive results in a late-stage trial of a treatment for active thyroid eye disease, or TED. The company said the phase 3 trial of teprotumumab met its primary endpoint of improving proptosis, or bulging of the eye compared with placebo, with 82.9% of patients showing improvement compared with 9.5% of placebo patients. The trial also succeeded in meeting secondary endpoints and achieving a consistent safety profile with the phase 2 study.
The company is expecting to submit a biologics license application to the U.S. Food and Drug Administration in mid-2019. TED is a progressive automimmune disease with a limited window for treatment without surgical intervention. As it progresses, it can lead to other eye issues and even blindness. Horizon shares have gained 49.9% in the last 12 months, while the S&P 500 (SPX) has gained 2.9%.
Horizon has high hopes for teprotumumab. In a November interview, CEO Walbert told Investor's Business Daily he expects the thyroid eye disease treatment to bring in a peak $750 million annually in the U.S. alone. The company's other key drug, a gout treatment, is expected to hit that same mark globally.
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