Tokumo Kana, Yoneda Tsuyoshi, Nakaniida Yuta, Aoki Ryota, Nakakura Shunsuke, Baba Taro, Okada Naoki, Edo Ayaka, Onoe Hiromitsu, Okumichi Hideaki, Hirooka Kazuyuki, Sonassa Diane, Tabuchi Hitoshi, Kiuchi Yoshiaki, Sakaguchi Hirokazu
Department of Ophthalmology and Visual Science, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
Department of Orthoptics, Faculty of Rehabilitation, Kawasaki University of Medical Welfare, Okayama, Japan.
PLoS One. 2025 Jul 11;20(7):e0326187. doi: 10.1371/journal.pone.0326187. eCollection 2025.
Conjunctival hyperemia was the most common adverse drug reaction to the ophthalmic solution omidenepag isopropyl in a post-marketing observational study. Here, we prospectively examined changes in hyperemia from before to 3 months after the initiation of the omidenepag isopropyl, a selective E-prostanoid receptor-2 receptor agonist, using hyperemia analysis software. Subjects were glaucoma patients who started omidenepag isopropyl use at Hiroshima University Hospital and Saneikai Tsukazaki Hospital. Hyperemia was compared by calculating the percentage coverage of vessels on the apex side using hyperemia analysis software based on anterior segment images. A total of 45 patients were enrolled, with 19 eyes in the new administration treatment group and 26 eyes in the group switched from F-prostanoid receptor agonists. Following switching from F-prostanoid receptor agonists to omidenepag isopropyl, there was no significant change in the hyperemia area from 7.4 (5.7-8.8) % to 7.4 (5.3-8.3)% (P = 0.53, Wilcoxon signed-rank test). In the new administration group, the hyperemia area increased significantly from7.0 (5.2-8.6) % to 8.2 (6.4-9.1) % (P = 0.02, Wilcoxon signed-rank test). There was no significant change in intraocular pressure (IOP) from 15.0 (12.0-17.0) mmHg to 14.0 (12.0-15.0) mmHg in the switching group (P = 0.37, Wilcoxon signed-rank test), whereas there was a significant IOP reduction from 15.0 (13.5-18.5) mmHg to 15.0 (11.0-16.5) mmHg (P = 0.03, Wilcoxon signed-rank test) in the new administration group. One eye in the new administration group that developed macular edema during the observation period resolved spontaneously upon discontinuing omidenepag isopropyl. Both hyperemia and IOP reduction with omidenepag isopropyl ophthalmic solution were comparable to those achieved with F-prostanoid receptor agonists.
在一项上市后观察性研究中，结膜充血是眼用溶液奥米地帕异丙酯最常见的药物不良反应。在此，我们使用充血分析软件，前瞻性地研究了选择性E-前列腺素受体-2受体激动剂奥米地帕异丙酯开始使用前至使用后3个月充血情况的变化。研究对象为在广岛大学医院和佐贺崎仁爱会医院开始使用奥米地帕异丙酯的青光眼患者。使用基于眼前节图像的充血分析软件，通过计算顶点侧血管覆盖百分比来比较充血情况。共纳入45例患者，新给药治疗组19只眼，从F-前列腺素受体激动剂转换组26只眼。从F-前列腺素受体激动剂转换为奥米地帕异丙酯后，充血面积无显著变化，从7.4（5.7 - 8.8）%变为7.4（5.3 - 8.3）%（P = 0.53，Wilcoxon符号秩和检验）。在新给药组，充血面积从7.0（5.2 - 8.6）%显著增加至8.2（6.4 - 9.1）%（P = 0.02，Wilcoxon符号秩和检验）。转换组眼压从15.0（12.0 - 17.0）mmHg至14.0（12.0 - 15.0）mmHg无显著变化（P = 0.37，Wilcoxon符号秩和检验），而新给药组眼压从15.0（13.5 - 18.5）mmHg显著降低至15.0（11.0 - 16.5）mmHg（P = 0.03，Wilcoxon符号秩和检验）。新给药组1只眼在观察期出现黄斑水肿，停用奥米地帕异丙酯后自发缓解。奥米地帕异丙酯眼用溶液引起的充血和眼压降低与F-前列腺素受体激动剂相当。
