Summary

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• This summary is based on the review of four randomized controlled trial(s). ^[1-4]
• Omidenepag Isopropyl (OMDI) vs Latanoprost (Primary Outcome: intraocular pressure (IOP) Reduction at Month 3): OMDI reduced IOP by 7.1 mmHg (28.8%) compared to Latanoprost’s reduction of 7.8 mmHg (31.3%), with a least-squares mean difference of 0.6 mmHg (95% confidence interval (CI): 0.0, 1.2 mmHg; p = 0.0366), confirming non-inferiority.
• OMDI vs Timolol (IOP-Lowering Efficacy Over 3 and 12 Months): OMDI showed IOP reductions of -5.6 to -5.9 mmHg (SPECTRUM 4) and -5.3 to -5.7 mmHg (SPECTRUM 3), while Timolol reduced IOP by -5.4 to -6.1 mmHg (SPECTRUM 4) and -6.4 to -7.0 mmHg (SPECTRUM 3), demonstrating consistent non-inferiority over both short- and long-term periods.
• Long-term IOP Reduction Over 52 Weeks (Group Comparisons): OMDI showed sustained IOP reductions: Group 1 (-3.7 mmHg), Group 2 (-5.6 mmHg), and Group 3 with Timolol (-8.4 mmHg).
• Adverse events (AEs) occurred in 40.0% of the OMDI group and 29.7% of the Latanoprost group. Ocular AEs were more common with OMDI (36.8%) compared to Latanoprost (21.1%), with treatment-associated ocular AEs reported in 23.2% of OMDI patients versus 11.9% in the Latanoprost group. Conjunctival hyperemia was more frequent with OMDI (11.9%) compared to Latanoprost (5.4%). Most AEs were mild, and no serious ocular AEs were observed.
• Conjunctival hyperemia occurred in 18.8% of patients in monotherapy groups and 45.0% in concomitant therapy groups. Macular edema or cystoid macular edema (ME/CME) was reported in 11.8% of monotherapy patients and 15.0% of those on concomitant therapy. No serious treatment-related AEs were observed, and most AEs were mild.
• OMDI demonstrated non-inferior efficacy in reducing IOP among Asian subjects with open-angle glaucoma or ocular hypertension and among Japanese patients, while prolonged OMDI use was associated with increased macular edema in pseudophakic patients. Pediatric patients were included, but no specific outcomes were provided for this subgroup.