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

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

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

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the results from studies on the beneficial effects of NCX 470 in a nonclinical model of endothelin-1 (ET-1)-induced ischemia/reperfusion damage of the optic nerve head and retina have been published online in the peer-reviewed Journal of Ocular Pharmacology and Therapeutics.

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

Based on recently published Phase 2 results, NCX 470 potentially has best-in-classintraocular pressurelowering efficacy in patients with open angle glaucoma or ocular hypertension,said Doug Hubatsch, Chief Scientific Officer of Nicox.These new results suggest that NCX 470 improves ocular hemodynamics and retinal function in an endothelin-1 induced rabbit model of retinal ischemia compared to vehicle and therefore it may have beneficial therapeutic properties over and above its intraocular pressure lowering activity, which could mean additional benefits over other treatments. Whilst elevated intraocular pressure is the main modifiable risk factor in glaucoma, a variety of other factors, including impaired ocular blood flow, are thought to contribute to damage of the optic nerve head and the retina, ultimately causing vision loss. Therefore, new treatments should aim to do more than just lowering of 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 once-daily dosed NCX 470 ophthalmic solution 0.1% over latanoprost ophthalmic solution 0.005% (first marketed as Xalatan), the most prescribed prostaglandin analog in the U.S. for patients with open-angle glaucoma or ocular hypertension. About Glaucoma and NCX 470 Glaucoma is a disease of the optic nerve which, if left untreated, can lead to irreversible vision loss. Glaucoma is frequently linked to elevated intraocular pressure (90% of patients) and is often due to blockage in the drainage system located in the front of the eye. Currently, reducing intraocular pressure remains the only way to slow the progression of the disease. About 3 million people in the United States between 40 and 80 years of age are affected by the most common form of glaucoma, open-angle glaucoma.

NCX 470 is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin analog eye drop designed to release bimatoprost and NO following instillation into the eye. Bimatoprost, marketed under the brand name LUMIGAN® by AbbVie, Inc., is one of the leading branded products in the class of prostaglandin analogs. Prostaglandin analogs are the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension. NCX 470 is in development to reduce IOP in patients with open-angle glaucoma or ocular hypertension. Nitric oxide brings additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action than that engaged by prostaglandin analogs.

About Nicox Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma. The company is also developing NCX 4251, a proprietary formulation of fluticasone propionate, for dry eye disease. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.

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

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

Bryan, Garnier & Co Dylan Van Haaften Paris, France
Edison Investment Research Pooya Hemami London, UK
H.C. Wainwright & Co Yi Chen New York, U.S.
Kepler Cheuvreux Arsene Guekam Paris, France   The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst repor

Gavin Spencer
Executive Vice President, Chief Business Officer
& Head of Corporate Development
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Investors & Media
United States & Europe
LifeSci Advisors, LLC
Sandya von der Weid
T +41 78 680 05 38 Forward-Looking Statements The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. 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 S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.

Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2021’ filed with the French Autorité des Marchés Financiers (AMF) on April 29, 2022 which is available on Nicox’s website ( Nicox S.A.
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