The US Food and Drug Administration (FDA) has approved Lumvoa (veligrotug) for the treatment of thyroid eye disease (TED), regardless of TED’s duration or activity.
TED is a chronic endocrine, autoimmune disease characterized by immune-mediated orbital inflammation that greatly impacts a person’s vision. The condition often occurs in people with hyperthyroidism or Graves’ disease, but also can occur in association with hypothyroidism, euthyroidism, and Hashimoto’s thyroiditis. Graves’ disease affects approximately 1% to 2% of the adult population, with an estimated 40% of patients subsequently developing TED over the course of their lifetime. The onset of TED typically occurs between 30 and 50 years of age, with the disease course more severe after the age of 50. Common symptoms can include ocular discomfort, upper eyelid retraction, dry eyes, tearing, inflammation, erythema, light sensitivity, and sensation of a foreign body present in the eye.
Veligrotug is a full antagonist of insulin-like growth factor-1 receptor (IGF-1R). The approval was based on data from the THRIVE (NCT05176639) and THRIVE-2 (NCT06021054) phase 3 clinical trials in active TED and chronic TED, respectively.
Both clinical trials met their respective primary and all secondary endpoints, consistently demonstrating statistically significant and clinically meaningful improvements at week 15 across all of the key signs and symptoms of TED.
In both studies, patients received a 12-week course of veligrotug designed to reduce the burden of treatment. Veligrotug demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks. This is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution in active and chronic TED.
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To learn more about TED and other rare ophthalmology conditions, visit https://checkrare.com/diseases/ophthalmology-eye-diseases/
