Nicox Highlights Positive NCX 470 Phase 3 Data Confirming Therapeutic Profile at the 2026 American Glaucoma Society Annual Meeting

February 24, 2026 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that positive data from the NCX 470 Phase 3 studies were highlighted in 2 podium presentations and a poster at the 2026 American Glaucoma Society (AGS) Annual Meeting (February 19 to February 22), one of the key scientific events in vision research.  

Data presented at AGS show that NCX 470, a novel, fast acting molecule, demonstrated best-in-class intraocular pressure (IOP) lowering efficacy of up to 10mmHg from baseline which has met the efficacy requirements for a New Drug Application in the U.S. and China.  

“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. Approximately 40% of glaucoma patients do not achieve their target intraocular pressure on existing monotherapies, therefore physicians need new and different effective treatment options, and we believe that NCX 470 could meet that need,” 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 favourable 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.”

Details of the AGS presentations

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” presented by Dr. S. Asrani, Duke University Medical Center, Durham, NC

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.

NCX 470 demonstrated fast, powerful, and consistent intraocular pressure (IOP) reduction of up to 10mmHg that was statistically superior to latanoprost at 3 of 6 time points. NCX 470 was safe and well tolerated with a low discontinuation rate.

Podium presentation: “Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (Nitric Oxide-Donating Bimatoprost): A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial” presented by Dr. A. Sit, Mayo Clinic, Rochester, Minnesota

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.

Poster: “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” presented by Dr. J. Bacharach, North Bay Eye Associates, Inc., Petaluma, CA

In the U.S. 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 pre-specified non-inferiority criteria compared with latanoprost 0.005% and achieved statistically greater IOP reductions at 3 of 6 evaluated timepoints. NCX 470 was safe and well tolerated, with no treatment-related serious adverse events and low, similar discontinuation rates between treatment groups.

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

Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX).

For more information www.nicox.com

H.C. Wainwright & Co        Yi Chen        New York, U.S.

Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).

Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.