Completion of the Observation Period for All Subjects in the Global Phase III Clinical Trials of K-321 for the Treatment of Fuchs Endothelial Corneal Dystrophy
Kowa Company, Ltd. (licensee)
Multiple countries and regions, including the United States and Europe; K-321 for the treatment of Fuchs endothelial corneal dystrophy
There is no change to the earnings forecasts for the fiscal year ending December 2026.
Related procedures
Global Phase III clinical trials
The subjects' data will be collected and compiled and analyzed going forward. The results will be disclosed promptly once they become available. The application for manufacturing and marketing approval is expected to be filed in 2027.
| Item | Details |
|---|---|
| Event name | Completion of the Observation Period for All Subjects in the Global Phase III Clinical Trials of K-321 for the Treatment of Fuchs Endothelial Corneal Dystrophy |
| Subject Entity | Kowa Company, Ltd. (licensee) |
| Target Locations / Products | Multiple countries and regions, including the United States and Europe; K-321 for the treatment of Fuchs endothelial corneal dystrophy |
| Impact on Earnings Forecast | There is no change to the earnings forecasts for the fiscal year ending December 2026. |
| Type of litigation or proceeding | Global Phase III clinical trials |
| Outlook | The subjects' data will be collected and compiled and analyzed going forward. The results will be disclosed promptly once they become available. The application for manufacturing and marketing approval is expected to be filed in 2027. |
| Planned follow-up disclosure | The results will be disclosed promptly once they become available. |
Items this document does not state (18)
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.The company was notified by Kowa Company, Ltd., the licensee, that the observation period for the subjects in the remaining trial had been completed.