Horizon Reports the Completion of Patients Enrollment of Tepezza (teprotumumab-trbw) in the P-III (OPTIC-J) Trial for the Treatment of Active Thyroid Eye Disease
Shots:
- The company has completed the patient enrollment of the P-III (OPTIC-J) trial evaluating the efficacy, tolerability & safety of Tepezza (q3w) vs PBO in a ratio (1:1) in patients with active TED in Japan. Patients will be eligible to enter an OLE period to receive an additional 8 infusions of Tepezza upon the completion of the treatment period & are proptosis non-responders @24wk.
- The primary efficacy EPs was proptosis response rate @24wk. as measured by the percentage of patients with a 2mm reduction in proptosis from baseline without deterioration in the fellow eye
- Tepezza was approved in the US in Jan 2020 & was the first medicine used to treat TED. The therapy has not been approved for commercial use in Japan
Ref: Horizon | Image: Horizon
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