TSING-HONG WANGAung, TinTinAungLu, Da-WenDa-WenLuGeorge, RonnieRonnieGeorgeSenthil, SirishaSirishaSenthilLu, FengheFengheLuOdani-Kawabata, NorikoNorikoOdani-KawabataPark, Ki HoKi HoPark2025-05-222025-05-222024https://scholars.lib.ntu.edu.tw/handle/123456789/729592Purpose: To compare the efficacy and safety of omidenepag isopropyl (OMDI) 0.002% with latanoprost 0.005% once daily in Asian subjects with open-angle glaucoma (OAG)/ocular hypertension (OHT). Methods: In this Phase III randomized, observer-masked, active-controlled, multinational trial (NCT02981446), subjects aged ≥18 years with OAG/OHT in both eyes and baseline intraocular pressure (IOP) ≥22 mmHg and ≤34 mmHg were randomized 1:1 to OMDI or latanoprost. IOP was measured at 9AM, 1PM, and 5PM at baseline, 1 week, 6 weeks, and 3 months. Adverse events (AEs) were recorded. Non-inferiority of OMDI to latanoprost was tested for primary and key secondary endpoints. Results: Each group included 185 subjects. Mean diurnal IOP from baseline to month 3 was reduced 7.1 mmHg (28.8%) with OMDI and 7.8 mmHg (31.3%) with latanoprost, with the least-squares mean difference (OMDI minus latanoprost) being 0.6 mmHg (95% CI: 0.0, 1.2 mmHg; p = 0.0366), indicating non-inferiority. Mean IOP reductions at the nine timepoints were −5.8 to −7.3 mmHg (23.5– 29.5%) for OMDI and −6.1 to −7.9 mmHg (24.3–31.7%) for latanoprost. Non-inferiority per FDA criteria was also met. Rates of all AEs, ocular AEs, and ocular AEs associated with treatment were 40.0%, 36.8%, and 23.2%, respectively, for OMDI and 29.7%, 21.1%, and 11.9%, respectively, for latanoprost. Conjunctival hyperemia rates were higher with OMDI than latanoprost (11.9% vs 5.4%). Most AEs were mild, with no serious ocular AEs. Conclusion: OMDI safely and effectively reduces IOP in Asian subjects with OAG/OHT, with mean diurnal IOP at Month 3 and per-timepoint IOP reductions non-inferior to those of latanoprost.englaucomaintraocular pressurelatanoprostocular hypertensionomidenepag isopropyl[SDGs]SDG2[SDGs]SDG3journal article10.2147/OPTH.S46536939051019