Amgen Reports Phase 3 Trial Success for Subcutaneous TEPEZZA in Treating Thyroid Eye Disease

Amgen has announced positive topline results from a Phase 3 clinical trial evaluating the efficacy and safety of a subcutaneous formulation of TEPEZZA® (teprotumumab-trbw) in adults with moderate-to-severe active thyroid eye disease (TED). The findings indicate that the subcutaneous version met its primary endpoint, demonstrating non-inferiority to the intravenous (IV) formulation in reducing proptosis, or bulging of the eyes, which is a key symptom of TED. The study also showed comparable safety profiles between the two formulations.

The Phase 3 trial enrolled adult participants diagnosed with moderate-to-severe active TED. Researchers assessed the effectiveness of the subcutaneous administration by measuring changes in proptosis from baseline at Week 24. Results confirmed that patients receiving the subcutaneous formulation experienced reductions in eye bulging similar to those observed with IV administration. Additionally, no new safety concerns emerged during the study, and adverse events were consistent with those previously reported for TEPEZZA®. These findings could provide an alternative delivery option for patients managing this rare autoimmune condition. Further details on secondary endpoints and additional analyses are expected to be shared at upcoming medical conferences or through peer-reviewed publications.

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Date: April 6, 2026

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GOAI