Assessment of the Anti-inflammatory Effects of NORFLO (R) ORO in Acute Relapses of HLA-B27-associated Autoimmune Uveitis: A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Study

Abstract

Background An effective therapy to reduce the number and severity of HLA-B27-related acute anterior uveitis (AAU) recurrences represents a clinical need. Curcumin is a promising therapeutic option in various inflammatory eye diseases. To enhance its absorption and eye tissue selectivity, a phospholipidic-curcumin complex (PHBC) has been formulated (Iphytoone (R), Eye Pharma S.p.A.). Aims This study investigates if PHBC is effective and safe to decrease the number and intensity of HLA-B27-related AAU relapses. Methods HLA-B27-related AAU patients were randomly divided to receive PHBC or placebo for 12 months (NCT03584724). Results Compared with the previous year, the number of relapses decreased in both groups. The proportion of responders was significantly higher in the PBHC group. The severity of attacks was comparable. The study drug was well tolerated. Conclusions A beneficial effect of PHBC treatment is suggested because the proportion of responders was significantly higher in this group of patients.