Omidenepag Isopropyl 0.002% versus Latanoprost 0.005% in Open-Angle Glaucoma/Ocular Hypertension: The Randomized Phase III PEONY Trial.

Autor: Wang TH; Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan., Aung T; Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.; Duke-NUS Medical School, Singapore.; Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore., Lu DW; Department of Ophthalmology, Tri-Service General Hospital, Taipei, Taiwan., George R; Sankara Nethralaya, Chennai, India., Senthil S; VST Centre for Glaucoma Care, Kallam Anji Reddy Campus, Hyderabad, India., Lu F; Santen Pharmaceuticals, Inc, Emeryville, CA, USA., Odani-Kawabata N; Santen Pharmaceuticals, Ltd, Osaka, Japan., Park KH; Department of Ophthalmology, Seoul National University, Seoul, Republic of Korea.
Jazyk: angličtina
Zdroj: Clinical ophthalmology (Auckland, N.Z.) [Clin Ophthalmol] 2024 Jul 16; Vol. 18, pp. 2093-2106. Date of Electronic Publication: 2024 Jul 16 (Print Publication: 2024).
DOI: 10.2147/OPTH.S465369
Abstrakt: Purpose: 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.
Competing Interests: Tsing Hong Wang is a consultant to AbbVie, Bausch & Lomb, Santen, and Viatris. Tin Aung is a consultant to Santen, AbbVie, Belkin Laser, Sun Pharma, and Novartis. Ronnie George is a consultant to AbbVie, Alcon, Santen, Sun Pharma, and Novartis. Ki Ho Park is a consultant to Santen, AbbVie, Novartis, and Sensimed. Noriko Odani-Kawabata is an employee of Santen. Fenghe Lu was an employee of Santen at the time of the study. The authors report no other conflicts of interest in this work.
(© 2024 Wang et al.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje