OPTIC Phase III trial of Tepezza shows benefits in less severe Thyroid Eye Disease.- Horizon Therapeutics

Horizon Therapeutics announced new Tepezza (teprotumumab-trbw) study data, including findings suggesting benefits of Tepezza in the less severe eye of patients with Thyroid Eye Disease (TED), and new data from the OPTIC 48-week follow-up study and OPTIC-X clinical trial. In patients with TED, one eye can have more severe symptoms than the other. The Tepezza Phase II clinical trial and OPTIC Phase III confirmatory clinical trial designated the more severely affected eye as the “study eye”. This new analysis focused specifically on efficacy of Tepezza in treating the less severe eye, or “fellow eye”, of patients in the Tepezza Phase II and III trials. Researchers analyzed the intent-to-treat (ITT) population in the Phase II and Phase III studies, defined as all patients randomized to receive Tepezza (n=84) and all patients randomized to receive placebo (n=87). The fellow eye was less proptotic than the study eye in both the Tepezza (21.61 mm vs. 23.02 mm) and placebo (21.97 mm vs. 23.15 mm) groups, indicating less severe disease. Additionally, the fellow eye, on average, demonstrated less inflammation based on the clinical activity score (CAS) than the study eye in both the Tepezza (CAS: 4.3 vs. 5.1 points) and placebo (CAS: 4.7 vs. 5.3 points) groups. Findings suggest that Tepezza may offer benefits in patients with less severe TED: At Week 24, more Tepezza patients were proptosis (eye bulging) responders (at least 2 mm reduction) in the fellow eye than placebo patients (63.1 percent vs. 8.0 percent, p<0.001), with a mean reduction in proptosis of 2.39 mm for tepezza patients and a mean increase in proptosis of 0.15 mm for placebo patients (p><0.001). 30 patients (34.5 percent) in the placebo group had a worsening of proptosis at week 24 in the fellow eye compared to 0 patients (0 percent) in the tepezza group. cas in the fellow eye decreased from baseline by a mean of -3.42 points in the tepezza group compared to -2.00 points in the placebo group (p><0.001) at week 24. more tepezza patients (63.1 percent) than placebo patients (26.4 percent) had a cas of 0 or 1 – signifying disease inactivation – in the fellow eye at week 24 (p><0.001). tepezza is the first and only medicine approved by the u.s. food and drug administration (fda) for the treatment of ted – a serious, progressive and vision-threatening rare autoimmune disease. data were presented at the american academy of ophthalmology annual meeting (aao 2020 virtual).>