Announced details
Cytomegalovirus corneal endotheliitis
Efficacy and safety confirmed (specific figures: Not disclosed)
ROHTO Pharmaceutical Co., Ltd. is developing the ganciclovir ophthalmic gel manufactured by Théa as a treatment for cytomegalovirus corneal endotheliitis. Capital and personnel relationships: Not disclosed.
An independent European pharmaceutical group that leads the ophthalmology field. It is a pioneer in preservative-free eye drops and offers a broad range of ophthalmic treatments. Location, representative, capital, and year established: Not disclosed.
Orphan drug designation
Ministry of Health, Labour and Welfare
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Koizumi, N., Miyazaki, D., Sugita, S. et al., Jpn J Ophthalmol 69, 296–307 (2025)
| Item | Details |
|---|---|
| Names of Products / Services Covered | ROH-101 (Ganciclovir Ophthalmic Gel) |
| Counterparty | Laboratories Théa（Théa） |
| Counterparty overview | An independent European pharmaceutical group that leads the ophthalmology field. It is a pioneer in preservative-free eye drops and offers a broad range of ophthalmic treatments. Location, representative, capital, and year established: Not disclosed. |
| Relationship with the Company | ROHTO Pharmaceutical Co., Ltd. is developing the ganciclovir ophthalmic gel manufactured by Théa as a treatment for cytomegalovirus corneal endotheliitis. Capital and personnel relationships: Not disclosed. |
| Applicable area | Cytomegalovirus corneal endotheliitis |
| Award/certification name | Orphan drug designation |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Quantitative Effects | Efficacy and safety confirmed (specific figures: Not disclosed) |
| Source | Koizumi, N., Miyazaki, D., Sugita, S. et al., Jpn J Ophthalmol 69, 296–307 (2025) |
Items this document does not state (9)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because efficacy and safety were confirmed in a Phase III, uncontrolled, open-label study conducted in Japan.