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New Data from Phase 3 Teprotumumab Trial Shows Dramatic Reduction in Proptosis, or Eye Bulging, the Main Cause of Morbidity in Active Thyroid Eye Disease
Horizon Pharma plc today announced that new data from the Phase 3 confirmatory clinical trial (OPTIC) evaluating the investigational medicine teprotumumab for the treatment of active thyroid eye disease (TED) were presented as part of a late-breaking oral presentation at the 2019 American Association of Clinical Endocrinologists (AACE) Scientific and Clinical Congress in Los Angeles. In addition to primary endpoint data previously announced on Feb. 28, 2019, the presentation includes new data from two secondary endpoints that show a dramatic reduction in proptosis (eye bulging) and a substantial improvement in overall response rate in patients treated with teprotumumab compared with placebo.
These data demonstrate the potential for teprotumumab as a treatment for Active TED, which currently has no U.S. Food and Drug Administration (FDA) approved treatments. Teprotumumab is an investigational medicine and its safety and efficacy have not been established.
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