Amgen, a biotechnology company, has shared promising results from a large clinical trial (Phase 3) testing a new under-the-skin injection version of the medication Tepezza for adults with moderate to severe Thyroid Eye Disease (TED). This disease can cause bulging eyes, double vision, and other vision problems, often making daily activities difficult. Currently, Tepezza is only available as an intravenous (IV) infusion, which requires a visit to a clinic or hospital.
In this study, the new injection version worked just as well as the IV version. By week 24, 76.7% of patients who received the injection saw a significant improvement in eye bulging, compared to only 19.6% of those who received a placebo. On average, eye bulging decreased by 3.17 millimeters, which is considered a meaningful improvement.
Jay Bradner, Amgen’s executive vice president of Research and Development, said: ‘These results confirm that Tepezza is highly effective for people with Thyroid Eye Disease. Now, with a new way to deliver the medication under the skin, patients may have an easier and more convenient option.’
The study also showed that the injection version improved other important aspects of the disease, such as reducing double vision, lowering disease activity scores, and improving quality of life related to appearance. While some patients reported better vision function, this improvement did not reach statistical significance.
Side effects of the injection version were similar to those seen with the IV version. The most common issues included muscle spasms, ringing in the ears, weight loss, ear discomfort, nausea, and diarrhea. A few patients experienced mild to moderate reactions at the injection site, but these did not cause anyone to stop treatment.
Dr. Madhura A Tamhankar, a professor of ophthalmology and neurology at the University of Pennsylvania, explained: ‘Thyroid Eye Disease can be very difficult for patients. It affects not just their vision but also their ability to go about daily life. Having a new way to take this medication could make treatment more accessible for more people. The fact that the injection works just as well as the IV version is a big step forward.’