At the 2026 American Glaucoma Society (AGS) Annual Meeting last week in Rancho Mirage, California, Nicox SA presented positive data from the NCX 470 phase 3 studies in 2 podium presentations and a poster. Data presented show that NCX 470, a novel, fast acting molecule, demonstrated best-in-class intraocular pressure (IOP) lowering efficacy of up to 10 mmHg from baseline which has met the efficacy requirements for a new drug application in the United States and China.

In the podium presentation, “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,” Sanjay G. Asrani, MD, of Duke University Medical Center in Durham, North Carolina, noted that the Denali phase 3 clinical trial met its primary endpoint of demonstrating non-inferiority of NCX 470 0.1% to latanoprost 0.005% at every time point. He also explained that NCX 470 demonstrated fast, powerful, and consistent IOP reduction of up to 10 mmHg that was statistically superior to latanoprost at 3 of 6 time points. NCX 470 was safe and well tolerated with a low discontinuation rate, he said.

In the podium presentation, “Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (Nitric Oxide-Donating Bimatoprost): A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial,” Arthur J. Sit, MD, of the Mayo Clinic in Rochester, Minnesota, explained that aqueous humor dynamics were measured in healthy adults without glaucoma. Subjects were randomized to receive either artificial tears or NCX 470 0.1% dosed once daily. NCX 470 significantly lowered IOP by a dual mechanism of action, increasing both the outflow facility and uveoscleral outflow, he noted.

In the poster presentation, “Outcomes in the United States Subgroup of the Denali Trial: A Randomized Trial Comparing NCX 470 0.1%, a Nitric Oxide-Donating Bimatoprost, and Latanoprost 0.005% for Open-Angle Glaucoma or Ocular Hypertension,” Jason Bacharach , MD, of North Bay Eye Associates in Petaluma, California, pointed out that in the US subgroup of the phase 3 Denali trial, NCX 470 0.1% demonstrated robust IOP lowering in patients with open-angle glaucoma or ocular hypertension. NCX 470 met the prespecified noninferiority criteria compared with latanoprost 0.005% and achieved statistically greater IOP reductions at 3 of 6 evaluated timepoints. NCX 470 was also safe and well tolerated, with no treatment-related serious adverse events and low, similar discontinuation rates between treatment groups, he said.

“Presentation of our NCX 470 phase 3 data at the prominent American Glaucoma Society meeting validates the importance of our development program in bringing an innovative intraocular pressure lowering drug to patients,” said Doug Hubatsch, chief scientific officer of Nicox. “These data further reinforce results we have previously announced demonstrating the robust intraocular pressure lowering effect and favorable safety profile of NCX 470. Furthermore, 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. 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.”

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