Notice of Manufacturing and Marketing Approval Application for "ROH-101 (Ganciclovir Eye Drops Gel)," a Treatment for Cytomegalovirus Corneal Endotheliitis

Note

Cytomegalovirus keratitis is a disease caused by cytomegalovirus, which triggers inflammation specific to the corneal endothelium. This disease leads to irreversible corneal endothelial dysfunction, and in advanced stages, can result in blindness. Currently, there are no approved treatments for this disease either domestically or internationally, and the development of new treatments is highly anticipated.

ROH-101 (ganciclovir eye drop gel) is an ophthalmic antiviral eye drop gel containing the active ingredient ganciclovir, and has been designated as an orphan drug by the Ministry of Health, Labour and Welfare for the treatment of cytomegalovirus keratitis.

Rohto Pharmaceutical Co., Ltd. conducted a Phase III uncontrolled, open-label trial of this drug in patients with cytomegalovirus keratitis in Japan,1) and, based on the confirmation of its efficacy and safety, submitted an application for manufacturing and marketing approval.
For this development, we have been working to develop ganciclovir eye drop gel, manufactured by Laboratories Théa (hereinafter "Théa"), as the world's first treatment for cytomegalovirus keratitis.

＜Théaについて＞

Théaは、眼科領域をリードするヨーロッパの独立系製薬グループ企業であり、防腐剤フリーの点眼薬におけるパイオニアとして眼科領域の治療薬を幅広くカバーしています。詳しくは、こちらをご覧ください。

＜参考文献＞

1) Koizumi, N., Miyazaki, D., Sugita, S. et al. Efficacy and safety of ROH-101 (0.15% ganciclovir gel) for cytomegalovirus corneal endotheliitis: an open-label, uncontrolled, phase 3 study in Japan. Jpn J Ophthalmol 69, 296–307 (2025).