Ocumension：NCX 470 is planned to be submitted for marketing approval.
On June 18 local time, Nicox SA announced that its exclusive license partner in China, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the CDE for NCX 470 . Ocumension considers the feedback sufficient to support the filing of a New Drug Application (NDA) for NCX 470 with the CDE .
NCX 470 (OT-301, bimatoprost grenod) is a novel compound combining a nitric oxide donor with a prostaglandin analog. It has a dual mechanism of action designed to lower intraocular pressure (IOP) and is intended for use in patients with open-angle glaucoma or ocular hypertension .
In December 2018, Ocumension obtained an exclusive license from Nicox to develop, manufacture, distribute, market, and sell NCX 470 in Greater China. This exclusive right was expanded in March 2020 to include South Korea and 12 countries in Southeast Asia .
In August 2025, Ocumension and Nicox jointly announced that the second international multicenter Phase III clinical study for NCX 470, the Denali study, met its primary endpoint . Following the successful completion of the first Phase III study, Mont Blanc, the results from both studies will be used to support NDA submissions for NCX 470 in both China and the United States .
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