Primary and Key Secondary Endpoints Met
77% of Patients Achieved Highly Statistically Significant Proptosis Response
Study Showed Clinically Meaningful Reduction in Proptosis; Greater Than 3 mm
THOUSAND OAKS, Calif., April 6, 2026 /PRNewswire/ -- Amgen (NASDAQ: AMGN) 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). TEPEZZA OBI provides comparable efficacy to, and builds upon the success of, intravenous (IV) TEPEZZA, the first and only medicine approved for the treatment of TED, which has now treated more than 25,000 patients worldwide.
The Phase 3 TEPEZZA OBI trial met its primary endpoint in moderate-to-severe active TED, showing a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period (76.7% TEPEZZA OBI vs. 19.6% placebo [p<0.0001]). Importantly, the mean proptosis reduction, a key secondary endpoint, was -3.17 mm at week 24 (-3.17 mm TEPEZZA OBI vs. -0.80 mm placebo; p<0.0001).
"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," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "With a well-understood mechanism and established impact in the clinic, we can evolve how the medicine is delivered to potentially reach even more patients through a more convenient subcutaneous option."
The trial also showed statistically significant and clinically meaningful improvements across the following additional secondary endpoints: overall responder rate; percentage of patients achieving a Clinical Activity Score (CAS) of 0 or 1; change in diplopia as ordinal response categories; diplopia response rate; complete diplopia responder rate; and mean change from baseline in week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) appearance subscale. Although not statistically significant, there was a numerical trend favoring TEPEZZA OBI in the mean change in baseline at week 24 in the GO-QoL visual functioning subscale. Full results from the study will be presented at an upcoming medical congress.
The overall safety results were generally consistent with the known safety profile of TEPEZZA IV1,2. Mild-to-moderate injection site reactions were observed with subcutaneous administration in some patients, which did not result in treatment interruption or discontinuation. The most common adverse events (≥10%) were muscle spasms, tinnitus, weight decrease, ear discomfort, nausea and diarrhea.
TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.3
"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," said Dr. Madhura A. Tamhankar, M.D., professor of ophthalmology and neurology at the Scheie Eye Institute, University of Pennsylvania. "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."
About the Phase 3 TEPEZZA OBI Trial
This Phase 3, randomized, double-masked, placebo-controlled, parallel-group, multicenter trial was to evaluate the efficacy and safety of subcutaneous TEPEZZA vs. placebo in patients with active TED. 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.
During the study, participants received TEPEZZA or placebo via an on-body injector every two weeks for a total of 12 injections. Inclusion criteria required a diagnosis of moderate-to-severe active TED within 15 months, as well as proptosis of ≥3 mm from baseline (prior to TED diagnosis), among other factors. Of note, participants with baseline hearing impairment, whether identified through medical history or audiogram, were allowed to participate in the study.
TEPEZZA IV Post-Marketing Requirement Study
Additionally, a separate Phase 3b/4 trial, conducted to fulfill an FDA post-marketing requirement for TEPEZZA IV, has been completed. The primary objective of the study was to evaluate the safety and tolerability of three treatment durations (four, eight and 16 infusions) of TEPEZZA IV and assess the need for retreatment. The study was descriptive in nature. The observed risk profile was consistent with the known profile of TEPEZZA IV. The post-marketing data will be submitted to regulatory authorities and presented at an upcoming medical congress.
About Thyroid Eye Disease (TED)
TED is a serious, progressive and potentially vision-threatening rare autoimmune disease.4 It often occurs in people living with Graves' disease, but is a distinct disease that is caused by autoantibodies activating an insulin-like growth factor-1 receptor (IGF-1R)-mediated signaling complex on cells within the retro-orbital space.5,6 This can lead to a cascade of potential negative effects, which may be vision threatening.7,8 Early signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and diplopia.
About TEPEZZA
TEPEZZA IV was approved in 2020 and remains the first and only approved medicine for TED and has changed the way the disease is treated by targeting a root cause of the condition. Its ability to significantly reduce proptosis and double vision - two hallmark symptoms of TED - has been consistently demonstrated in multiple global clinical studies2,3 and reinforced by six years of real-world experience in more than 25,000 patients.9,*
INDICATION
TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.
Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD. If IBD exacerbation is suspected, discontinue use of TEPEZZA.
Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA.
Hearing Impairment?Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients' hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, ear discomfort, weight decrease, nail disorders and menstrual disorders.
Please seeFull Prescribing Informationor visitTEPEZZAhcp.comfor more information.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.
Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.
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References
*Based on 25,062 individual patients enrolled in Amgen By Your Side who received at least one dose of TEPEZZA from 02/05/2020 - 11/14/2025.
(1)
Smith TJ, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. 2017; N Engl J Med 2017; 376:1748-1761DOI: 10.1056/NEJMoa1614949.
2
Douglas RS, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
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Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:249125.
4
Ponto KA, et al. Quality of life and occupational disability in endocrine orbitopathy. Dtsch Arztebl Int. 2009;106(17):283-289.
5
Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251-257.
6 Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves' Disease Is Mediated Through the Insulin-Like Growth Factor 1
Receptor Pathway. J Immunol. 2003;170:6348-6354.
7
McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves' Orbitopathy (EUGOGO ) survey. Br J Ophthalmol. 2007;91:455-458.
8 Bartalena L, et al. The 2021 European Group on Graves' Orbitopathy (EUGOGO) Clinical Practice Guidelines for the Medical Management of Graves' Orbitopathy [published online ahead of print].
Eur J Endocrinol. 2021 Jul 1:EJE-21-0479.R1.
9
Data on file, Amgen; 2025.
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