Nicox Receives Positive FDA Feedback for NCX 470 Glaucoma Treatment Ahead of NDA Submission

Nicox SA, an international ophthalmology company, announced that it has received positive written feedback from a pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration for its lead clinical product candidate, NCX 470. The minutes confirm that the current data package and the proposed content and format of the proposed NDA application is generally acceptable for submission.

The pre-NDA meeting with the FDA was conducted with Nicox's partner Kowa Co., Ltd. for NCX 470. The FDA requested complementary pharmacokinetic data, which will be generated in a small number of patients as part of an ongoing study in Japan, and will not impact any timelines.

The NDA remains on track for submission in summer 2026, and the NDA submission in China is expected shortly after submission in the U.S. Nicox will now transfer ownership of the application to Kowa to make the submission as planned in the summer of 2026. Nicox will receive a milestone payment from Kowa upon submission of the NDA.

NCX 470 (bimatoprost grenod) is a novel nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The NDA submission is 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. The outcome supports the finalization of the registration dossier with its comprehensive data package, including positive results from two Phase 3 studies.

NCX 470 is licensed globally to Kowa, except in the Chinese market, South Korea and Southeast Asia, where it is licensed to Ocumension Therapeutics. Nicox may receive regulatory and sales milestones and will be paid royalties on worldwide sales. All regulatory and commercialization costs are borne by Kowa and Ocumension.

A Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025.