Amgen Reports Positive Phase III Results for Subcutaneous Tepezza for Thyroid Eye Disease

Amgen has reported encouraging Phase III results for a subcutaneous version of Tepezza in adults with moderate-to-severe Thyroid Eye Disease (TED), a rare autoimmune condition marked by eye bulging, double vision, and vision complications.

Administered via an on-body injector, the therapy matched the efficacy of the approved intravenous formulation. The randomized, double-masked, placebo-controlled trial achieved its primary endpoint, with 77% of patients showing a proptosis response at 24 weeks. Mean proptosis reduction reached 3.17 mm, alongside improvements in clinical activity score, diplopia, and quality of life measures.

Safety outcomes were consistent with the IV form, with mostly mild adverse events such as diarrhoea, nausea, tinnitus, and injection site reactions. Treatment was delivered biweekly over 12 doses, including patients with prior hearing impairment, supporting broader usability and convenience.

07-04-2026