Nicox Completes Enrollment for NCX 470 Phase 3 Trial in China Ahead of Schedule

Nicox SA, an international ophthalmology company, has announced that its Denali Phase 3 trial for NCX 470, targeting open-angle glaucoma or ocular hypertension, has completed patient enrollment in China earlier than anticipated. This follows the completion of patient recruitment in the U.S. in July 2024. The trial's topline results are now projected for the third quarter of 2025.

Doug Hubatsch, Chief Scientific Officer of Nicox, expressed his gratitude to the teams at Nicox, Ocumension, the clinical staff, and patients for their dedication, which facilitated the early closure of Chinese patient recruitment. The focus now shifts to finalizing the necessary development steps to support New Drug Applications (NDA) in both the United States and China, aiming for submission soon after the Denali trial results are available.

NCX 470 has garnered significant interest from potential commercialization partners, particularly in the U.S. Nicox has established strong collaborations in Japan, China, Korea, and Southeast Asia and is now concentrating on the U.S. market, considering regional partnerships.

The Denali trial is assessing the efficacy of a once-daily dose of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. This multi-country trial, involving the U.S. and China, is equally funded by Nicox and Ocumension, Nicox’s exclusive licensee for certain regions in Asia. The trial, along with the Mont Blanc trial, aims to meet the clinical regulatory requirements for NDA submissions of NCX 470 in the U.S. and China. Nicox anticipates submitting a U.S. NDA potentially in the first half of 2026, contingent on securing a U.S. commercialization partnership or appropriate funding.

The Mont Blanc trial, the first Phase 3 trial, showed promising results for NCX 470, demonstrating an IOP-lowering effect from baseline of 8.0 to 9.7 mmHg compared to 7.1 to 9.4 mmHg for latanoprost. The primary efficacy analysis met the statistical non-inferiority versus latanoprost, and NCX 470 showed superiority at four out of six timepoints. These results, published in the American Journal of Ophthalmology, indicate that NCX 470 met the efficacy criteria for U.S. approval and was well tolerated, with low discontinuation rates.

NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, combines the IOP-lowering effects of NO and prostaglandin analogs (PGAs). It releases bimatoprost and NO into the eye to lower IOP through two different mechanisms. NO enhances aqueous humor drainage, while bimatoprost, marketed as LUMIGAN® by AbbVie, Inc., is a leading PGA for IOP reduction in glaucoma or ocular hypertension patients.

Nicox SA is dedicated to developing innovative ophthalmic solutions to maintain vision and improve ocular health. Their lead clinical development program is NCX 470. Additionally, Nicox has a preclinical research program, NCX 1728, and generates revenue from VYZULTA® and ZERVIATE®, licensed in various regions. Nicox is headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris under the ticker symbol ALCOX.