DUBLIN - Horizon Therapeutics plc (Nasdaq: HZNP) today announced that The New England Journal of Medicine has published comprehensive results of the Phase 3 OPTIC clinical trial evaluating TEPEZZA (teprotumumab-trbw) for Thyroid Eye Disease (TED).
OPTIC is part of the largest clinical program in TED and demonstrates that TEPEZZA provides significant improvements in proptosis (eye bulging) and diplopia (double vision) compared to placebo.
TEPEZZA is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions. TEPEZZA was approved by the U.S. Food and Drug Administration (FDA) on January 21, 2020 making it the first and only medicine approved for the treatment of TED. The medicine received Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA.
'Thyroid Eye Disease is a rare, devastating autoimmune disease that is not adequately treated, leaving patients to struggle for years until they become candidates for surgeries that are not only complex, but often don't fully restore vision or appearance,' said Raymond Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center and co-principal investigator of the OPTIC trial. 'In this clinical trial, we saw statistically significant improvements across critical symptoms including proptosis and diplopia - at the first patient assessment at six weeks of treatment, and those improvements continued over the 24-week treatment period. TEPEZZA, which was just recently approved by the FDA, has the potential to significantly change the treatment paradigm in a disease where patients have historically had to watch and wait in pain as symptoms progress and put them at risk for serious vision impairment.'
OPTIC compared the efficacy and safety of TEPEZZA to placebo administered by infusion once every three weeks for a total of eight infusions. As previously reported, the trial met its primary endpoint and all secondary endpoints.
Key trial findings published in The New England Journal of Medicineinclude the following1: Proptosis: At Week 24, more patients receiving TEPEZZA (83%) versus placebo (10%) had a 2 mm reduction of proptosis in the study eye, without deterioration in the fellow eye (p
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