Nicox SA (ALCOX.PA,COX.PA,NICXF.PK), an ophthalmology firm, announced that it has received positive written feedback from a pre-NDA or New Drug Application meeting with the U.S. Food and Drug Administration FDA for its lead clinical product candidate, NCX 470.
Nicox also noted that the FDA has requested complementary pharmacokinetic data, which will be generated in a small number of patients as part of an ongoing study in Japan and it will not impact any timelines.
The pre-NDA meeting with the FDA was conducted with Nicox's partner Kowa Co., Ltd. (49N.F) for NCX 470.
Nicox affirmed that the NDA remains on track for summer 2026, and the NDA submission in China is expected shortly after submission in the U.S.
NCX 470 (bimatoprost grenod) is a nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
NCX 470 is licensed to Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and to Kowa in other parts of the world. Nicox may receive regulatory and sales milestones and will be paid royalties on worldwide sales. Kowa and Ocumension will bear all regulatory and commercialisation costs.
The NDA submission was based on Phase 3 clinical data showing that NCX 470 lowered intraocular pressure by up to 10 mmHg in patients with open-angle glaucoma or ocular hypertension.
"Nicox will now transfer ownership of the application to Kowa to make the submission as planned in the summer of 2026, " said Doug Hubatsch, EVP and Chief Scientific Officer of Nicox.
ALCOX.PA closed Monday's trade at 0.41 Euros, up 6.46%.
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