Amgen Announces Positive Topline Phase 3 Results for Subcutaneous TEPEZZA® in Adults with Moderate-to-Severe Active Thyroid Eye Disease

Primary and Key Secondary Endpoints Met, 77% of Patients Achieved Highly Statistically Significant Proptosis Response

Apr. 6, 2026 at 1:53pm

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Amgen today announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI) in participants with moderate-to-severe active Thyroid Eye Disease (TED). The trial met its primary endpoint, showing a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period. The study also demonstrated statistically significant and clinically meaningful improvements across several secondary endpoints.

Why it matters

The positive results extend and support the efficacy of TEPEZZA, the first and only approved medicine for TED, by providing a more convenient subcutaneous administration option that can potentially reach even more patients living with this serious, progressive and vision-threatening rare autoimmune disease.

The details

The Phase 3 TEPEZZA OBI trial evaluated the efficacy and safety of subcutaneous TEPEZZA vs. placebo in patients with active TED. Participants received TEPEZZA or placebo via an on-body injector every two weeks for a total of 12 injections. The primary endpoint was proptosis responder rate (percentage of participants with a ≥2-mm reduction from baseline in proptosis in the study eye without deterioration [≥2-mm increase] of proptosis in the fellow eye) at Week 24.

  • The Phase 3 TEPEZZA OBI trial was conducted in 2025.

The players

Amgen

An American multinational biopharmaceutical company that discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases.

TEPEZZA

The first and only approved medicine for the treatment of Thyroid Eye Disease, which has now treated more than 25,000 patients worldwide.

Thyroid Eye Disease (TED)

A serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.

Dr. Madhura A. Tamhankar, M.D.

Professor of ophthalmology and neurology at the Scheie Eye Institute, University of Pennsylvania.

Jay Bradner, M.D.

Executive vice president of Research and Development at Amgen.

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What they’re saying

“These results extend and support the best-in-class efficacy of TEPEZZA for people living with Thyroid Eye Disease, now with subcutaneous administration delivering IV-level efficacy.”

— Jay Bradner, M.D., Executive vice president of Research and Development at Amgen

“Thyroid Eye Disease can be a profoundly debilitating condition, affecting not only vision but also daily functioning with symptoms like double vision and eye bulging. Expanding administration options through subcutaneous delivery opens the possibility of a more accessible experience for patients with Thyroid Eye Disease and is critical to serving diverse patient needs. The potential to achieve comparable efficacy to IV makes this advancement compelling.”

— Dr. Madhura A. Tamhankar, M.D., Professor of ophthalmology and neurology at the Scheie Eye Institute, University of Pennsylvania

What’s next

The full results from the study will be presented at an upcoming medical congress.

The takeaway

The positive topline results for subcutaneous TEPEZZA demonstrate the potential to provide a more convenient administration option that can deliver comparable efficacy to the intravenous formulation, which could help expand access and better serve the diverse needs of patients living with the debilitating effects of Thyroid Eye Disease.