Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension

Naka Shiratori,1,2 Yusuke Nishio,1,2 Ayaka Takeda,1,2 Shio Sugimoto,1,2 Kenji Takazawa,2 Naomi Otsuka,3 Naruhiro Ishida,3 Daisuke Shii,3 Kiyotaka Hori,3 Kenji Nakamoto1 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Japan Medical Affairs Group,...

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Autores principales:	Shiratori N, Nishio Y, Takeda A, Sugimoto S, Takazawa K, Otsuka N, Ishida N, Shii D, Hori K, Nakamoto K
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	omidenepag isopropyl prostanoid ep2 agonist 24-hour iop control Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/73b6835fdbf44df590df1d2a07b4f63d
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spelling	oai:doaj.org-article:73b6835fdbf44df590df1d2a07b4f63d2021-12-02T17:41:42ZTwenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension1177-5483https://doaj.org/article/73b6835fdbf44df590df1d2a07b4f63d2021-10-01T00:00:00Zhttps://www.dovepress.com/twenty-four-hour-intraocular-pressure-control-with-omidenepag-isopropy-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Naka Shiratori,1,2 Yusuke Nishio,1,2 Ayaka Takeda,1,2 Shio Sugimoto,1,2 Kenji Takazawa,2 Naomi Otsuka,3 Naruhiro Ishida,3 Daisuke Shii,3 Kiyotaka Hori,3 Kenji Nakamoto1 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Japan Medical Affairs Group, Santen Pharmaceutical Co. Ltd., Osaka, JapanCorrespondence: Naka ShiratoriDepartment of Ophthalmology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, JapanTel +81-3-3822-2131Fax +81-3-5685-0988Email shiratori@nms.ac.jpPurpose: To clarify the intraocular pressure (IOP)-lowering effect of a selective prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI) during a 24-hour period.Patients and Methods: Subjects aged ≥ 20 years and with diagnosed, untreated primary open-angle glaucoma or ocular hypertension were enrolled. IOP measurements were performed every 4 hours over a 24-hour period using a Goldmann applanation tonometer (GAT) and Icare PRO tonometer (PRO). The baseline 24-hour IOP was measured in untreated subjects. After the baseline measurements, participants were given OMDI 1 drop once daily at night for 4 weeks. At week 4, the IOP measurement was repeated under the same conditions. Diurnal (9 am, 1 pm, 5 pm) and nocturnal (9 pm, 1 am, 5 am) IOP measurements were compared between baseline and treatment with OMDI. Safety measures included adverse events, slit-lamp biomicroscopy, visual acuity, heart rate and blood pressure.Results: Of 27 participants enrolled, 25 patients (20 males and 5 females, average age 52.2 ± 8.5 years) completed the study. In the sitting position, the baseline diurnal and nocturnal mean IOPs (GAT) were 19.1 ± 2.1 mmHg and 18.2 ± 2.6 mmHg, respectively, the diurnal and nocturnal mean IOP reduction from baseline were – 2.8 ± 2.6 mmHg (p < 0.0001) and – 3.3 ± 2.9 mmHg (p < 0.0001), respectively, mean 24-hour IOP (GAT) was significantly lower with the OMDI treatment (− 3.1 ± 2.5 mmHg, p < 0.0001). In the supine position, the baseline nocturnal mean IOP (PRO) was 17.99 ± 2.22 mmHg, and the nocturnal mean IOP reduction from baseline was − 1.78 ± 2.37 mmHg (p = 0.0009) after 4 weeks of the treatment. Nine adverse events were observed in 8 patients including mild conjunctival hyperemia (n = 8) and mild iritis (n=1). There were no significant effects on systemic safety.Conclusion: Once daily OMDI treatment was able to produce stable 24-hour IOP reduction.Keywords: omidenepag isopropyl, prostanoid EP2 agonist, 24-hour IOP controlShiratori NNishio YTakeda ASugimoto STakazawa KOtsuka NIshida NShii DHori KNakamoto KDove Medical Pressarticleomidenepag isopropylprostanoid ep2 agonist24-hour iop controlOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 3997-4003 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	omidenepag isopropyl prostanoid ep2 agonist 24-hour iop control Ophthalmology RE1-994
spellingShingle	omidenepag isopropyl prostanoid ep2 agonist 24-hour iop control Ophthalmology RE1-994 Shiratori N Nishio Y Takeda A Sugimoto S Takazawa K Otsuka N Ishida N Shii D Hori K Nakamoto K Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
description	Naka Shiratori,1,2 Yusuke Nishio,1,2 Ayaka Takeda,1,2 Shio Sugimoto,1,2 Kenji Takazawa,2 Naomi Otsuka,3 Naruhiro Ishida,3 Daisuke Shii,3 Kiyotaka Hori,3 Kenji Nakamoto1 1Department of Ophthalmology, Nippon Medical School, Tokyo, Japan; 2Shinanozaka Clinic, Tokyo, Japan; 3Japan Medical Affairs Group, Santen Pharmaceutical Co. Ltd., Osaka, JapanCorrespondence: Naka ShiratoriDepartment of Ophthalmology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, JapanTel +81-3-3822-2131Fax +81-3-5685-0988Email shiratori@nms.ac.jpPurpose: To clarify the intraocular pressure (IOP)-lowering effect of a selective prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI) during a 24-hour period.Patients and Methods: Subjects aged ≥ 20 years and with diagnosed, untreated primary open-angle glaucoma or ocular hypertension were enrolled. IOP measurements were performed every 4 hours over a 24-hour period using a Goldmann applanation tonometer (GAT) and Icare PRO tonometer (PRO). The baseline 24-hour IOP was measured in untreated subjects. After the baseline measurements, participants were given OMDI 1 drop once daily at night for 4 weeks. At week 4, the IOP measurement was repeated under the same conditions. Diurnal (9 am, 1 pm, 5 pm) and nocturnal (9 pm, 1 am, 5 am) IOP measurements were compared between baseline and treatment with OMDI. Safety measures included adverse events, slit-lamp biomicroscopy, visual acuity, heart rate and blood pressure.Results: Of 27 participants enrolled, 25 patients (20 males and 5 females, average age 52.2 ± 8.5 years) completed the study. In the sitting position, the baseline diurnal and nocturnal mean IOPs (GAT) were 19.1 ± 2.1 mmHg and 18.2 ± 2.6 mmHg, respectively, the diurnal and nocturnal mean IOP reduction from baseline were – 2.8 ± 2.6 mmHg (p < 0.0001) and – 3.3 ± 2.9 mmHg (p < 0.0001), respectively, mean 24-hour IOP (GAT) was significantly lower with the OMDI treatment (− 3.1 ± 2.5 mmHg, p < 0.0001). In the supine position, the baseline nocturnal mean IOP (PRO) was 17.99 ± 2.22 mmHg, and the nocturnal mean IOP reduction from baseline was − 1.78 ± 2.37 mmHg (p = 0.0009) after 4 weeks of the treatment. Nine adverse events were observed in 8 patients including mild conjunctival hyperemia (n = 8) and mild iritis (n=1). There were no significant effects on systemic safety.Conclusion: Once daily OMDI treatment was able to produce stable 24-hour IOP reduction.Keywords: omidenepag isopropyl, prostanoid EP2 agonist, 24-hour IOP control
format	article
author	Shiratori N Nishio Y Takeda A Sugimoto S Takazawa K Otsuka N Ishida N Shii D Hori K Nakamoto K
author_facet	Shiratori N Nishio Y Takeda A Sugimoto S Takazawa K Otsuka N Ishida N Shii D Hori K Nakamoto K
author_sort	Shiratori N
title	Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
title_short	Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
title_full	Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
title_fullStr	Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
title_full_unstemmed	Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension
title_sort	twenty-four-hour intraocular pressure control with omidenepag isopropyl 0.002% in patients with glaucoma and ocular hypertension
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/73b6835fdbf44df590df1d2a07b4f63d
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Twenty-Four-Hour Intraocular Pressure Control with Omidenepag Isopropyl 0.002% in Patients with Glaucoma and Ocular Hypertension

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