オミデネパグイソプロピル点眼液の効果と安全性の検討：平均10か月成績

Evaluation of the efficacy and safety of medium-term of treatment with omidenepag isopropyl ophthalmic solution

要約　目的：0.002％オミデネパグイソプロピル点眼液（オミデネパグ）の中期眼圧下降作用と安全性について検討した。

対象：かなもり眼科クリニックにてオミデネパグを投与した両眼有水晶体の緑内障連続94例である。

結果：有効性は点眼開始後6か月以上経過を追えた3群（新規群n＝62，追加群n＝7，変更群n＝13）から解析を行い，中止例n＝12についても検討した。投与前と6か月後の眼圧は，それぞれ新規群で17.1±2.2，13.9±2.4mmHg，追加群で15.9±3.2，14.1±2.3mmHgであり，有意な眼圧下降が得られた（mixed effect model，p＜0.01）が，変更群では有意差はなかった。角膜厚は新規群と変更群で有意に肥厚化した（対応のあるt検定，p＜0.05）。中止例のうち，4例はノンレスポンダーと判断したもの，8例は1例の虹彩炎と1例の黄斑浮腫を含む副作用発現症例であり，これらの副作用はすべて点眼中止により軽快した。

結論：オミデネパグは6か月以上にわたり有意に眼圧を下降させる。忍容性もあり，有水晶体眼には第一選択薬の緑内障点眼薬と位置づけてよいと考える。

Abstract　Purpose：To evaluate the medium-term efficacy of 0.002％ omidenepag isopropyy ophthalmic solution（Eybelis, omidenepag）, respectively, by assessing its intraocular pressure（IOP）-lowering capability and safety in patients with glaucoma.

Patients and Methods：Ninety-four patients who were newly administered EYB were enrolled in the study. Patients continuing omidenepag over 6 months were divided into 3 groups；first administration, addition to existing drugs, and switching group. The following data were retrieved from the medical records and used for retrospective analyses：monthly IOP, spherical equivalent, and central corneal thickness. Patients were monitored for adverse reactions.

Results：IOP at baseline and after 6 months was 17.1±2.2 and 13.9±2.4 mmHg in the first group, 15.9±3.2 mmHg and 14.1±2.3 mmHg in the additional group, respectively. There were significant decreases in IOP in the first and additional groups（mixed effect model, p＜0.01）, but none in the switching group. The central corneal thickness was significantly thickened in the first and switching groups（paired t-test, p＜0.05）. Four patients were non-responders. Although adverse reactions occurred in 8 patients, including iritis and macular edema in 1 patient each, these recovered by the end of Omidenepag.

Conclusion：Omidenepag was effective in reducing IOP over a 6 month period. Omidenepag was well-tolerated and could be a first-line drug for treating phakic glaucomatous patients.