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Top-line results from the OPTIC trial showed that the phase 3 study met its primary endpoint, demonstrating that more patients with active thyroid eye disease assigned teprotumumab experienced a meaningful improvement in proptosis, or protrusion of the eyeball, compared with patients assigned placebo, according to a press release from Horizon Pharma.
In the study, designed to investigate the efficacy, tolerability and safety of teprotumumab in patients with active thyroid eye disease, researchers assigned 83 patients to teprotumumab or placebo in eight IV infusions (10 mg/kg for the first infusion followed by 20 mg/kg for the remaining seven infusions) every 3 weeks for 21 weeks, according to the release. The primary endpoint was a 2 mm or more reduction of proptosis in the study eye, without deterioration in the fellow eye, at week 24. Proptosis is the main cause of morbidity in thyroid eye disease.
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