2.1. Demographic and Clinical Parameters
corneal keratopathy
In total, 138 patients with AKU were enrolled in the 4-year, open-label, evaluator-blind, randomised, no-treatment controlled, parallel-group SONIA 2 study. Of these, 69 were treated with 10 mg of nitisinone daily for 4 years, except for 10 patients who developed corneal keratopathy and received 2 mg daily instead [The majority of the SONIA 2 population was Caucasian, with 60% being males. The median age was 50 years, and the median BMI was 26 kg/m