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Horizon Initiates P-III (OPTIC-J) Trial of Teprotumumab for the Treatment of Active Thyroid Eye Disease

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Horizon Initiates P-III (OPTIC-J) Trial of Teprotumumab for the Treatment of Active Thyroid Eye Disease

Shots:

  • The 1st patient has been enrolled in a P-III (OPTIC-J) trial to evaluate the efficacy, tolerability & safety of teprotumumab vs PBO in a ratio (1:1) in 50 adults with active TED across the US & EU
  • The primary efficacy EPs is proptosis response rate @24wks. & also evaluates ORR, change from baseline in proptosis measurement, diplopia responder rate & change from baseline in the GO-QoL questionnaire @24wks.
  • Additionally, patients will enter an OLE period to receive an additional 8 infusions of teprotumumab @24wks. during the 48wk. follow-up, following the completion of the treatment period & proptosis non-responders. The therapy has been marketed under the brand name Tepezza in the US

 Ref: Horizon | Image: Horizon

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