Nicox Announces Publication of NCX 470 Results Demonstrating Improvements in Ocular Hemodynamics and Retinal Cell Physiology


Nicox Announces Publication of NCX 470 Results Demonstrating Improvements in Ocular Hemodynamics and Retinal Cell Physiology

July 7, 2022 – release at 7:30 am CET
Sophia-Antipolis, France

Nicox S.A. (Euronext Paris: FR0013018124, COX), an international society of ophthalmology, announces today that the results of studies on the beneficial effects of NCX 470 in a non-clinical model of optic ischemia/reperfusion injury induced by endothelin-1 (ET-1) nerve head and retina was published online in the peer-reviewed journal Journal of Ocular and Therapeutic Pharmacology.

The publication “NCX 470 restores ocular hemodynamicss and retinal cell physiology after ET-1-induced ischemia/reperfusion injury of the optic nerve and retina in rabbits” from Bastia et al. is available by clicking here. NCX 470, Nicox’s lead clinical product candidate, is a novel, potentially best-in-class, nitric oxide (NO)-releasing prostaglandin eye drops currently in Phase 3 clinical development for the reduction of intraocular pressure ( PIO) in patients with angle glaucoma or ocular hypertension.

Based on recently published Stage 2 results, NCX470 potentially has the best in its classintraocular pressurelowering efficiency in patients with open-angle glaucoma or ocular hypertension,said Doug HubatschChief Scientific Officer of Nicox.These new resultss suggest that NCX 470 improves ocular hemodynamics and retinal function in a rabbit model of endothelin-1-induced retinal ischemia compared to vehicle and, therefore, it may have beneficial therapeutic properties beyond its intraocular pressure lowering activity, which could mean additional advantages over other treatments. Oup to the height intraocular pressure is the main editable risk factor for glaucoma, a variety others factors, including impaired eye blood circulation, are designed for contribute to damage to the optic nerve head and retina, ultimately causing loss of vision. Therefore, nNew treatments should aim to do more than just lowering intraocular pressure.

NCX 470 is currently being evaluated in two multi-regional Phase 3 clinical trials, Mont Blanc and Denali. The statistical objective of these two phase 3 trials is to demonstrate non-inferiority and, if successful, statistical superiority in IOP lowering of single dose 0.1% NCX 470 Ophthalmic Solution over day compared to latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed prostaglandin analogue in the United States for patients with open-angle glaucoma or ocular hypertension . About Glaucoma and NCX470 Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. Glaucoma is frequently linked to high intraocular pressure (90% of patients) and is often due to a blockage in the drainage system at the front of the eye. Currently, reducing intraocular pressure remains the only way to slow the progression of the disease. In the United States, approximately 3 million people between the ages of 40 and 80 are affected by the most common form of glaucoma, open-angle glaucoma.

NCX 470 is a new, potentially best-in-class, nitric oxide (NO)-donating prostaglandin-like eye drop designed to release bimatoprost and NO after instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by AbbVie, Inc., is one of the leading brand name products in the prostaglandin analog class. Prostaglandin analogues are the most widely used class of drugs to lower IOP in patients with open-angle glaucoma or ocular hypertension. NCX 470 is being developed to lower IOP in patients with open-angle glaucoma or ocular hypertension. Nitric oxide provides additional IOP lowering efficacy by improving drainage of aqueous humor from the eye via a different mechanism of action than that engaged by prostaglandin analogues.

About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve eye health. Nicox’s lead clinical development program is NCX 470, a novel nitric oxide-donating prostaglandin analogue, intended to reduce intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone propionate, for dry eye. Nicox Generates Revenues from VYZULTA® in Glaucoma, Licensed Worldwide Exclusively to Bausch + Lomb, and ZERVIATE® in Allergic Conjunctivitis, Licensed in Multiple Geographies, Including Eyevance Pharmaceuticals, LLC, USA and Ocumension Therapeutics in China and most Southeast Asian markets.

Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indices.

For more information about Nicox, its products or its pipeline, please visit: Analyst coverage

Bryan, Garnier & Co Dylan Van Haaften Paris, France
Edison Investment Research Pooya Hemami London, United Kingdom
HC Wainwright & Co Yi Chen New York, USA
Kepler Cheuvreux Arsene Guekam Paris, France The opinions expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. In addition, the information contained in their reports may not be correct or up to date. Nicox assumes no obligation to correct or update the information contained in the analyst report.

Gavin Spencer
Executive Vice President, Chief Business Officer
& Business Development Manager
T +33 (0)4 97 24 53 00
[email protected]

Investors & Media
United States and Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38
[email protected] Forward-looking statements The information contained in this document is subject to change without notice. This information includes forward-looking statements. These forward-looking statements are not guarantees of future performance. These statements are based on the current expectations or beliefs of the management of Nicox SA and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox SA and its affiliates, directors, officers, employees, advisors or agents, do not undertake and have no obligation to provide any updates or revise any forward-looking statements.

The risk factors likely to have a significant effect on Nicox’s business are presented in the 3rd chapter of ‘Universal registration document, annual financial report and management report 2021‘ filed with the French Financial Markets Authority (AMF) on April 29, 2022 available on the Nicox website ( Nicox S.A.
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