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# Horizon Therapeutics Touts Thyroid Eye Disease Data
- URL: https://www.fdaweb.com/horizon-therapeutics-touts-thyroid-eye-disease-data/
- Published: 2023-04-10T12:00:00.000Z
- Updated: 2026-09-14T18:24:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154176

Horizon Therapeutics says it plans to discuss with FDA positive and statistically significant topline results from its randomized, double-masked, placebo-controlled Phase 4 clinical trial ([NCT04583735](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04583735%3Fcond%3Dtepezza%26draw%3D2%26rank%3D1&esheet=53377746&newsitemid=20230410005144&lan=en-US&anchor=NCT04583735&index=1&md5=c212a68f4c8fa059bdb074f4145daf56&ref=fdaweb.com)) evaluating Tepezza for treating adults with chronic thyroid eye disease and low Chronic/Low Clinical Activity Score (CAS), which is a measure of disease activity. FDA approved Tepezza (teprotumumab-trbw) in early 2020 for the disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).

According to the company, “topline data per the pre-specified primary analysis method (intent-to-treat) demonstrated that the primary endpoint was met, and patients treated with Tepezza achieved a statistically significant reduction in proptosis from baseline compared to those receiving placebo. In addition, in the pre-specified per-protocol analysis, the differences between patients treated with Tepezza and patients treated with placebo increased.”