TY - JOUR
T1 - Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan
AU - Nakazawa, Toru
AU - Takahashi, Kanji
AU - Kuwayama, Yasuaki
AU - Nomura, Akio
AU - Shimada, Fumiki
N1 - Funding Information:
We thank the participants included in this study. We wish to express our gratitude to the physicians at the medical institutions who cooperated in the study. Sponsorship and article processing charges for this study were funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Funding Information:
We thank the participants included in this study. We wish to express our gratitude to the physicians at the medical institutions who cooperated in the study. Sponsorship and article processing charges for this study were funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan. Support for this project and the journal?s Rapid Service and Open Access fees were funded by Santen Pharmaceutical Co., Ltd., Osaka, Japan. Medical writing assistance, in the form of the preparation and revision of the manuscript, was supported financially by Santen Pharmaceutical Co., Ltd., Osaka, Japan and provided by Enago Life Sciences, Mumbai, India, based on a draft provided by the authors, their feedback and under their conceptual direction. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Toru Nakazawa, Kanji Takahashi, Yasuaki Kuwayama, Akio Nomura and Fumiki Shimada contributed to the study design, statistical analysis and interpretation of data. All authors drafted the manuscript, revised it, and decided to submit the article for publication. Toru Nakazawa has received grants and personal fees from Santen Pharmaceutical, Senju Pharmaceutical, Kowa Company, Topcon Corporation, Wakamoto Pharmaceutical, Nidek Corporation, Rohto Pharmaceutical, Alcon Japan, and Novartis. Kanji Takahashi has received grants and personal fees from Santen Pharmaceutical, Alcon Japan, Hoya, Novartis, Otsuka Pharmaceutical, Senju Pharmaceutical, Kowa Company, Bayer Yakuhin, Kyowa Kirin, Allergan Japan, Ono Pharmaceutical and Nitto Medic. Yasuaki Kuwayama has received grants and personal fees from Otsuka Pharmaceutical, Kowa Company, Ltd., Santen Pharmaceutical, Senju Pharmaceutical, Alcon Japan, Pfizer Japan, Wakamoto Pharmaceutical Co., Ltd., AMO Japan K.K, Glaukos Japan GK, Sucampo Pharma, Novartis Pharma K.K. and Aerie Pharmaceuticals. Akio Nomura is an employee of Santen Pharmaceutical Co., Ltd. Fumiki Shimada is an employee of Santen Pharmaceutical Co., Ltd. This current ongoing post-marketing, multicenter, prospective, non-interventional, observational study is being conducted in accordance with the requirements of the regulatory authority in Japan, the Good Post-Marketing Study Practice (MHLW Ordinance No. 171; December 20, 2004). Since the research protocol was reviewed and approved by the regulatory authority in Japan before beginning the study, approval by the ethics review committees at each participating medical institution is not required. Data are available from the corresponding author upon reasonable request.
Funding Information:
Toru Nakazawa has received grants and personal fees from Santen Pharmaceutical, Senju Pharmaceutical, Kowa Company, Topcon Corporation, Wakamoto Pharmaceutical, Nidek Corporation, Rohto Pharmaceutical, Alcon Japan, and Novartis. Kanji Takahashi has received grants and personal fees from Santen Pharmaceutical, Alcon Japan, Hoya, Novartis, Otsuka Pharmaceutical, Senju Pharmaceutical, Kowa Company, Bayer Yakuhin, Kyowa Kirin, Allergan Japan, Ono Pharmaceutical and Nitto Medic. Yasuaki Kuwayama has received grants and personal fees from Otsuka Pharmaceutical, Kowa Company, Ltd., Santen Pharmaceutical, Senju Pharmaceutical, Alcon Japan, Pfizer Japan, Wakamoto Pharmaceutical Co., Ltd., AMO Japan K.K, Glaukos Japan GK, Sucampo Pharma, Novartis Pharma K.K. and Aerie Pharmaceuticals. Akio Nomura is an employee of Santen Pharmaceutical Co., Ltd. Fumiki Shimada is an employee of Santen Pharmaceutical Co., Ltd.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/3
Y1 - 2022/3
N2 - Introduction: This post-marketing observational interim analysis evaluated the 12-month effectiveness and safety of omidenepag isopropyl (OMDI) ophthalmic solution in daily clinical settings. Methods: This was a multicenter, large-scale, non-interventional, prospective, observational study conducted in Japan. The target enrollment was 3900 patients, and the overall observation period was 12 months. Patients with glaucoma and ocular hypertension (OH) with no previous history of OMDI use were enrolled. The key endpoints were change in intraocular pressure (IOP) from baseline and the incidence of adverse reactions (ADRs). Results: A total of 1862 patients were evaluated in this 12-month interim analysis. Most patients were diagnosed with normal-tension glaucoma (NTG, 62.0%). The treatment patterns with OMDI were naïve monotherapy (48.4%), switching monotherapy (18.4%), and concomitant therapy (31.1%). The overall incidence of ADRs was 24.3%, which was similar between the monotherapy and concomitant therapy groups. Common ADRs were conjunctival hyperemia, refractive disorder, and myopia. Macular edema was observed in four patients. No ADRs categorized as prostaglandin-associated periorbitopathy were observed. There was a significant reduction in mean IOP at 12 months, with a change of − 1.9 ± 2.9 mmHg from baseline (reduction − 10.4 ± 16.5%). The mean IOP change from baseline was − 2.7 ± 2.6 mmHg in the naïve monotherapy group, − 1.1 ± 2.6 mmHg in the switching monotherapy group, and − 1.6 ± 3.1 mmHg in the concomitant therapy group (all P < 0.05). The mean IOP decreased by − 2.5 ± 3.2 mmHg, − 1.5 ± 2.4 mmHg, and − 2.3 ± 4.5 mmHg in the primary open-angle glaucoma (POAG), NTG, and OH groups, respectively. The treatment persistence with OMDI was 82.4%. Conclusion: This study demonstrated the safety and efficacy of OMDI for glaucoma and OH as monotherapy and concomitant therapy in daily clinical settings. In this interim analysis, OMDI showed a favorable benefit–risk profile, and can be first-line therapy for glaucoma.
AB - Introduction: This post-marketing observational interim analysis evaluated the 12-month effectiveness and safety of omidenepag isopropyl (OMDI) ophthalmic solution in daily clinical settings. Methods: This was a multicenter, large-scale, non-interventional, prospective, observational study conducted in Japan. The target enrollment was 3900 patients, and the overall observation period was 12 months. Patients with glaucoma and ocular hypertension (OH) with no previous history of OMDI use were enrolled. The key endpoints were change in intraocular pressure (IOP) from baseline and the incidence of adverse reactions (ADRs). Results: A total of 1862 patients were evaluated in this 12-month interim analysis. Most patients were diagnosed with normal-tension glaucoma (NTG, 62.0%). The treatment patterns with OMDI were naïve monotherapy (48.4%), switching monotherapy (18.4%), and concomitant therapy (31.1%). The overall incidence of ADRs was 24.3%, which was similar between the monotherapy and concomitant therapy groups. Common ADRs were conjunctival hyperemia, refractive disorder, and myopia. Macular edema was observed in four patients. No ADRs categorized as prostaglandin-associated periorbitopathy were observed. There was a significant reduction in mean IOP at 12 months, with a change of − 1.9 ± 2.9 mmHg from baseline (reduction − 10.4 ± 16.5%). The mean IOP change from baseline was − 2.7 ± 2.6 mmHg in the naïve monotherapy group, − 1.1 ± 2.6 mmHg in the switching monotherapy group, and − 1.6 ± 3.1 mmHg in the concomitant therapy group (all P < 0.05). The mean IOP decreased by − 2.5 ± 3.2 mmHg, − 1.5 ± 2.4 mmHg, and − 2.3 ± 4.5 mmHg in the primary open-angle glaucoma (POAG), NTG, and OH groups, respectively. The treatment persistence with OMDI was 82.4%. Conclusion: This study demonstrated the safety and efficacy of OMDI for glaucoma and OH as monotherapy and concomitant therapy in daily clinical settings. In this interim analysis, OMDI showed a favorable benefit–risk profile, and can be first-line therapy for glaucoma.
KW - Adverse reaction
KW - Glaucoma
KW - Intraocular pressure
KW - Omidenepag isopropyl
KW - Ophthalmology
KW - Post-marketing
UR - http://www.scopus.com/inward/record.url?scp=85123497404&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85123497404&partnerID=8YFLogxK
U2 - 10.1007/s12325-021-02035-8
DO - 10.1007/s12325-021-02035-8
M3 - Article
C2 - 35072890
AN - SCOPUS:85123497404
SN - 0741-238X
VL - 39
SP - 1359
EP - 1374
JO - Advances in Therapy
JF - Advances in Therapy
IS - 3
ER -