Nicox Completes U.S. Recruitment for Denali Phase 3 Trial of NCX 470

Nicox SA, an international ophthalmology company, announced the recruitment and randomization of the final patient in the U.S. for its Denali Phase 3 trial of NCX 470. This trial examines the safety and efficacy of NCX 470 in patients with open-angle glaucoma or ocular hypertension. The topline results are anticipated in the second half of 2025, contingent on the conclusion of patient recruitment in the U.S. and the ongoing progress of the trial in China.

Doug Hubatsch, Nicox's Chief Scientific Officer, expressed gratitude to the patients, clinical sites, internal team, and investors for their contributions to reaching this significant milestone in the Denali trial. He emphasized the company's commitment to NCX 470 and the importance of continuing patient recruitment in China to ensure the trial's completion and anticipated results in H2 2025.

The Denali trial aims to compare the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution at 0.1% against latanoprost ophthalmic solution at 0.005% in patients with open-angle glaucoma or ocular hypertension. Conducted in both the U.S. and China, the trial is financially supported equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea, and Southeast Asia. Along with the Mont Blanc trial, Denali is designed to meet the regulatory requirements for the submission of New Drug Applications (NDA) for NCX 470 in the U.S. and China.

The NDA submission for NCX 470 in the U.S. is expected in the first half of 2026. The first Phase 3 trial, Mont Blanc, demonstrated that NCX 470 could reduce IOP from baseline by 8.0 to 9.7 mmHg, compared to reductions of 7.1 to 9.4 mmHg with latanoprost. The trial met the primary efficacy analysis's statistical non-inferiority criteria and showed superiority in four out of six time points, thus fulfilling the efficacy requirements for U.S. approval. Additionally, NCX 470 was well tolerated with low discontinuation rates. The results from Mont Blanc have been published in the American Journal of Ophthalmology, with numerous post hoc analyses also shared in various forums.

Nicox SA is an international ophthalmology company focused on innovative solutions to maintain vision and improve ocular health. Its lead program, NCX 470 (a nitric oxide-donating bimatoprost eye drop), is in clinical development to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also generates revenue from VYZULTA® for glaucoma, licensed globally to Bausch + Lomb, and ZERVIATE® for allergic conjunctivitis, licensed in different regions including the U.S. to Harrow, Inc., and to Ocumension Therapeutics in China and much of Southeast Asia. Nicox is headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris under the ticker symbol ALCOX. The company is also part of the CAC Healthcare index.