24 January 2020 - - The New England Journal of Medicine has published comprehensive results of the Phase 3 OPTIC clinical trial evaluating Tapezza (teprotumumab-trbw) for Thyroid Eye Disease, Dublin-based Horizon Therapeutics plc (NASDAQ: HZNP) said.

OPTIC is part of the largest clinical program in TED and demonstrates that Tapezza provides significant improvements in proptosis (eye bulging) and diplopia (double vision) compared to placebo.

Tapezza is a fully human monoclonal antibody 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.

Tapezza was approved by the US Food and Drug Administration 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.

OPTIC compared the efficacy and safety of Tapezza 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.

At Week 24, more patients receiving Tapezza versus placebo had a ≥ 2 mm reduction of proptosis in the study eye, without deterioration in the fellow eye (p