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# FDA Approves Horizon’s Rare Eye Disease Drug
- URL: https://www.fdaweb.com/fda-approves-horizons-rare-eye-disease-drug/
- Published: 2020-01-21T12:00:00.000Z
- Updated: 2026-09-14T15:59:24.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145891

FDA has approved a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye 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). Approval was based on data from two studies (Study 1 and 2) in 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo. “Of the patients who were administered Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2 millimeter reduction in proptosis (eye protrusion) as compared to 20% and 10% of subjects who received placebo, respectively,” an FDA [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease?ref=fdaweb.com) says. “The most common adverse reactions observed in patients treated with Tepezza are muscle spasm, nausea, alopecia (hair loss), diarrhea, fatigue, hyperglycemia (high blood sugar), hearing loss, dry skin, dysgeusia (altered sense of taste) and headache.”