Nicox SA, an international ophthalmology company, announces that its exclusive Japanese partner, Kowa, has initiated a Phase III safety clinical trial of NCX 470 (also known as K-911) in Japan for the treatment of ocular hypertension, triggering a €2 million milestone payment to Nicox.
Only one Phase III confirmatory clinical trial in Japanese patients, which will start shortly, plus this safety trial, is required for submission for marketing approval of NCX 470 in Japan.
Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox.
“Thanks to our continuing collaborative efforts after Kowa received approval to initiate this trial, we are very pleased to announce that the first patient has been enrolled."
"The Phase III trials in Japan are being managed and financed by Kowa; only one confirmatory Phase III trial is expected to be needed to make a submission for marketing approval of NCX 470 in Japan,” said Doug Hubatsch, EVP Scientific Officer of Nicox.
The trial is a safety study and is detailed here: JRCT Safety Trial NCX 470.
The 500-patient confirmatory trial is expected to start shortly and is detailed here: JRCT Confirmatory Trial NCX 470.