Horizon Completes Enrollment for Phase III Study of Candidate in Thyroid Eye Disease

September 7, 2018: By Joan McKenna

Horizon Pharma announced Sept. 4 that it completed enrollment ahead of schedule for its Phase III confirmatory study of teprotumumab in patients with moderate to severe active thyroid eye disease.

The Dublin-based company said topline results are expected in Q2-2019.

Horizon describes thyroid eye disease, also called Graves’ orbitopathy, as a rare autoimmune disease in which the insulin-like growth factor receptor is overexpressed in eye tissue, resulting in inflammation, orbital fibroblast proliferation, and tissue expansion, which can in turn lead to bulging of the eye, or proptosis. The inability for those with the disease to close their eyelids can lead to corneal ulcerations and potential blindness.

Teprotumumab is a fully human monoclonal antibody and a targeted inhibitor of the insulin-like growth factor 1 receptor.

It has received breakthrough therapy, orphan drug, and fast track designations from the US FDA.

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