Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study.

American Journal of Ophthalmology
Makoto AiharaNaveed K Shams

Abstract

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 III, randomized, investigator-masked, active-controlled, parallel-group, noninferiority study (ClinicalTrials.govNCT02623738). 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 9:00 AM, 1:00 PM, and 5:00 PM at weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at week 4. The noninferiority margin for OMDI versus latanoprost was 1.5 mm Hg. Adverse events (AEs) were recorded. Of the 190 patients randomized, 189 had at least 1 post-baseline IOP measurement. At baseline, patients who received OMDI or latanoprost had a mean ± SD diurnal IOP of 23.78 ± 1.73 mm Hg and 23.40 ± 1.51 mm Hg, respectively. At week 4, least-squares mean ± SE reduction in IOP from baseline with OMDI (-5.93 ± 0.23 mm Hg) was noninferior to that of latanoprost (-6.56 ± 0.22 mm Hg; 95% confidence interval between groups: 0.01-1.26). The most frequently reported treatmen...Continue Reading

Citations

Feb 19, 2021·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Masahiro FuwaNaveed K Shams
Apr 30, 2021·Expert Opinion on Drug Discovery·Francesco MincioneClaudiu T Supuran
Jul 7, 2021·Japanese Journal of Ophthalmology·Makoto Aihara
Nov 19, 2021·Seminars in Ophthalmology·Rei SakataLouis B Cantor
Mar 12, 2021·Journal of Nippon Medical School = Nippon Ika Daigaku Zasshi·Kenji NakamotoHiroshi Takahashi
Dec 17, 2021·FASEB Journal : Official Publication of the Federation of American Societies for Experimental Biology·Yosuke IdaHiroshi Ohguro
Jan 18, 2022·Clinical & Experimental Ophthalmology·Robert J Casson

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