Key Takeaways

  • NCX 470 phase 3 data showed up to 10 mmHg IOP reduction from baseline, meeting efficacy requirements for new drug applications in the US and China.

  • In the Denali phase 3 trial, NCX 470 0.1% demonstrated noninferiority to latanoprost at all time points and achieved statistically greater IOP reductions at three of six measured time points, with a favorable safety profile.

  • Clinical findings confirmed NCX 470’s dual mechanism of action—enhancing both trabecular meshwork and uveoscleral outflow.

Nicox announced that positive data from its NCX 470 phase 3 clinical program were featured in two podium presentations and a poster at the 2026 American Glaucoma Society (AGS) annual meeting, held February 19–22. 

Data presented at the meeting showed that NCX 470, a novel, fast-acting nitric oxide-donating bimatoprost, demonstrated best-in-class IOP lowering efficacy of up to 10 mmHg from baseline. The results met the efficacy requirements for a new drug application (NDA) in both the United States and China.

In a podium presentation titled, “A Randomized Trial Comparing NCX 470 0.1%, a Nitric Oxide-Donating Bimatoprost, and Latanoprost 0.005% for Open-Angle Glaucoma or Ocular Hypertension: The DENALI Trial,” Dr. S. Asrani of Duke University Medical Center reported that the Denali phase 3 trial met its primary endpoint. NCX 470 0.1% demonstrated noninferiority to latanoprost 0.005% at every evaluated time point. NCX 470 achieved fast, powerful and consistent IOP reductions of up to 10 mmHg and was statistically superior to latanoprost at three of six measured time points. The therapy was reported to be safe and well tolerated, with a low discontinuation rate.

In a second podium presentation, “Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (Nitric Oxide-Donating Bimatoprost): A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial,” Dr. A. Sit of the Mayo Clinic presented findings from a study conducted in healthy adults without glaucoma. Participants were randomized to receive either artificial tears or once-daily NCX 470 0.1%. Results showed that NCX 470 significantly lowered IOP through a dual mechanism of action by increasing both trabecular outflow facility and uveoscleral outflow, confirming the mechanism previously observed in preclinical models.

A poster presentation titled, “Outcomes in the United States Subgroup of the Denali Trial,” presented by Dr. J. Bacharach of North Bay Eye Associates, highlighted results from the US patient population enrolled in the phase 3 Denali trial. In this subgroup, NCX 470 0.1% demonstrated robust IOP lowering in patients with open-angle glaucoma or ocular hypertension. The therapy met pre-specified noninferiority criteria compared with latanoprost and achieved statistically greater IOP reductions at three of six time points. NCX 470 was safe and well tolerated, with no treatment-related serious adverse events and low, comparable discontinuation rates between treatment groups.

The podium presentations and poster are available on Nicox’s website in the Publications section.

“Our clinical data presented validate the dual mechanism of intraocular pressure lowering through the trabecular meshwork and uveoscleral pathways that had previously been shown in animal models," said Doug Hubatsch, Chief Scientific Officer of Nicox. "Importantly, pre-planned analysis of the NCX 470 phase 3 data demonstrates additional differentiation in intraocular pressure reduction; and preclinical data, which have already been reported, suggest potential benefits in retinal protection.”