Nicox Announces Last Patients Complete Final Visit in NCX 470 Phase 3 Mont Blanc Glaucoma Trial

Press Release
Nicox Announces Last Patients Complete Final Visit in NCX 470 Phase 3 Mont Blanc Glaucoma Trial
The last patients completed their final (3-month) visit on September 16 691 patients were enrolled in the Mont Blanc trial Topline results of the Mont Blanc trial due in early November 2022 September 19, 2022– release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the last patients completed their final (3-month) visit in the Mont Blanc Phase 3 clinical trial of NCX 470 0.1% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. A total of 691 patients were enrolled in the trial. NCX 470, Nicox’s lead clinical product candidate, is a novel, potentially best-in-class, nitric oxide (NO)-donating prostaglandin analog eye drop. “We are pleased to have reached this milestone in the Mont Blanc Phase 3 clinical trial, and I would particularly like to thank our clinical sites and the Nicox development team for their incredible efforts in continuing to drive this trial to completion in the face of the COVID-19 pandemic situation.” said Doug Hubatsch, EVP, Chief Scientific Officer of Nicox.  “NCX 470 has the potential to be a best-in-class glaucoma treatment, and we look forward to sharing the topline results in early November.” Mont Blanc is a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution, 0.005%. Latanoprost is the most widely prescribed first-line therapy for open-angle glaucoma or ocular hypertension. The primary efficacy evaluation in Mont Blanc is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. The second Phase 3 trial on NCX 470, Denali, is being jointly conducted and equally financed with our Chinese partner, Ocumension Therapeutics. Topline results is currently expected after 2024.
About Nicox
Nicox SA 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 open-angle glaucoma or ocular hypertension. The company is also conducting research on NCX 1728, a nitric oxide-donating phosphodiesterase 5 inhibitor, in intraocular pressure lowering and retinal conditions. NCX 4251, a novel, patented, ophthalmic suspension fluticasone propionate nanocrystals for topical ocular application for dry eye disease, is being developed by Ocumension Therapeutics in China under an exclusive license agreement and is available for partnering elsewhere. 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 (a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd.), 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: www.nicox.com.
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 reports.
Nicox Gavin Spencer Executive Vice President, Chief Business Officer & Head of Corporate Development T [phone] [e-mail]	Investors & Media United States & Europe LifeSci Advisors, LLC Sandya von der Weid T [phone] [e-mail]
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 (www.nicox.com)
Nicox S.A. Drakkar 2 Bât D, 2405 route des Dolines CS 10313, Sophia Antipolis 06560 Valbonne, France T [phone] F [phone]

 

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• EN_NCX 470 MontBlanc LPLV PR_20220919