To evaluate the efficacy and safety of omidenepag isopropyl (OMDI), a selective, non-prostaglandin, prostanoid EP2 receptor agonist, in Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Phase 3, randomized, investigator-masked, active-controlled, parallel-group, non-inferiority study (NCT02623738).
After a washout period of 1-4 weeks, eligible patients were randomized (1:1) to OMDI 0.002% or latanoprost 0.005% once daily for 4 weeks. Intraocular pressure (IOP) was measured at 9 AM, 1 PM, and 5 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The non-inferiority margin for OMDI versus latanoprost was 1.5 mmHg. Adverse events (AEs) were recorded.
Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients receiving OMDI or latanoprost had a mean diurnal IOP (±SD) of 23.78±1.73 mmHg and 23.40±1.51 mmHg, respectively. At week 4, least-squares mean (±SE) reduction in IOP from baseline with OMDI (-5.93±0.23 mmHg) was non-inferior to that of latanoprost (-6.56±0.22 mmHg; 95% confidence interval between groups: 0.01, 1.26). The most frequently reported treatment-related ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (23/94 [24.5%] versus 10/96 [10.4%]), corneal thickening (11/94 [11.7%] versus 1/96 [1.0%]), and punctate keratitis (0/94 versus 5/96 [5.2%]). No serious AEs were observed in either group and there were no discontinuations related to the study drug.
OMDI 0.002% was non-inferior to latanoprost 0.005% in reducing IOP in patients with OHT or POAG and was well tolerated.
Copyright © 2020. Published by Elsevier Inc.