Post-operative ocular inflammation : A single sub-conjunctival injection of XG-102 compared to dexamethasone drops in a randomized trial

Abstract Purpose To evaluate the efficacy and safety of XG-102 (brimapitide) compared to dexamethasone eye-drops in the treatment of post-operative ocular inflammation. Design Multicenter, randomized, parallel group, double-masked, non-inferiority clinical trial Patients Patients who underwent anterior and posterior segments combined surgery, or glaucoma surgery, or complex posterior segment surgery, were eligible to participate. Intervention Patients were administered a single sub-conjunctival injection of 250 μl XG-102 90 μg (N=47) or 900 μg (N=48) or placebo (N=50) at the end of ocular surgery. Sub-conjunctival injection for each group, XG-102 90μg, XG-102 900μg or placebo, is followed by eye drops instilled 4 times/day for 21 days with placebo, placebo or dexamethasone solutions, respectively. Main outcome measure The primary outcome measure was anterior chamber cells grade at day 28 comparing XG-102 900 μg with dexamethasone. Results The anterior cells grade for the XG-102 groups was non-inferior to dexamethasone (-0.054 anterior cell grade, 95% Confidence Interval (CI) -0.350 - 0.242, p for non-inferiority