Horizon says new data from teprotumumab study shows 'significant benefit'
Horizon Therapeutics announced new data from the Phase 3 OPTIC confirmatory clinical trial showing that teprotumumab provided significant benefit on several devastating effects of active thyroid eye disease, or TED, compared with placebo, including diplopia, quality of life and clinical activity score. These data were presented during the American Society of Ophthalmic Plastic and Reconstructive Surgery 50th Anniversary 2019 Fall Scientific Symposium, and build upon data presented earlier this year that demonstrated the significant benefit of teprotumumab on proptosis. Teprotumumab is an investigational medicine for the treatment of active TED and is currently under review by the FDA. The teprotumumab Biologics License Application, or BLA, was recently granted Priority Review by the FDA and if approved, teprotumumab would be the first FDA-approved medicine for the treatment of active TED. The Prescription Drug User Fee Act, or PDUFA, goal date is March 8, 2020.