Postoperative Ocular Inflammation: A Single Subconjunctival Injection of XG-102 Compared to Dexamethasone Drops in a Randomized Trial

Abstract

To evaluate the efficacy and safety of XG-102 (brimapitide) compared to dexamethasone eye drops in the treatment of postoperative ocular inflammation. Multicenter, randomized, parallel group, double-masked, noninferiority clinical trial. Patients who underwent anterior and posterior segments combined surgery or glaucoma surgery or complex posterior segment surgery were eligible to participate. Patients were administered a single subconjunctival injection of 250μL XG-102 90μg (n= 47) or 900μg (n= 48) or placebo (n= 50) at the end of ocular surgery. Subconjunctival injection for each group (XG-102 90 μg, XG-102 900μg, or placebo) was followed by eye drops instilled 4 times per day for 21days with placebo, placebo, or dexamethasone solution, respectively. The primary outcome measure was anterior chamber cell grades at day 28 comparing XG-102 900μg with dexamethasone. The anterior cell grades for both XG-102 groups were noninferior to dexamethasone (-0.054anterior cell grade [95% confidence interval-0.350-0.242]; P < .001 for noninferiority) for XG-102 900μg and-0.086 anterior cell grade (95% confidence interval-0.214-0.385; P= .003 for noninferiority) for XG-102 90μg. Rescue medication was introduced for 10 (21%), 7 (15%), and 2 (4%) patients allocated to the XG-102 90μg, XG-102 900μg, and dexamethasone groups, respectively. The difference between XG-102 90μg and dexamethasone was statistically significant (P= .013). The number of patients for whom adverse events were reported and the nature of the events reported was similar between the 3 treatment groups. A single subconjunctival injection of XG-102 at the end of ocular surgery is noninferior to dexamethasone eye drops in the treatment of postoperative ocular inflammation.