Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations
| Press Release | ||
| Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations | ||
Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has completed the additional pre-planned analyses of the NCX 470 Denali Phase 3 clinical trial data. These analyses confirm an efficacy profile similar to that seen in subgroup analysis of the Mont Blanc trial. In addition, reduction in intraocular pressure (IOP) was measured in the long-term safety extension period of the Denali trial from 6 months through to 12 months. NCX 470 maintained robust IOP reduction during this period with no additional safety signals seen. New Drug Applications (NDAs) for NCX 470 are in preparation for the U.S. and China. A full summary of the status of NCX 470 was given in our Press Release of September 4, 2025. The Company plans to publish further data at upcoming ophthalmology conferences. Key Future Milestones
Denali Trial Design Similar to Mont Blanc, Denali is a randomized, multi-regional, double-masked, parallel group trial that evaluated the safety and efficacy of NCX 470 ophthalmic solution, 0.1% compared to latanoprost ophthalmic solution, 0.005% in 696 patients in 90 sites in the U.S. and China. Latanoprost is the most widely prescribed first-line therapy for open-angle glaucoma or ocular hypertension. The primary efficacy evaluation was based on reduction from baseline in mean time-matched IOP at 6 timepoints: 8 AM and 4 PM at week 2, week 6 and month 3. The Denali trial also included a long-term safety extension from 6 months through to 12 months and was jointly conducted and equally financed with our Chinese partner, Ocumension Therapeutics. | ||
| About Nicox | ||
| Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX). For more information www.nicox.com | ||
| Analyst coverage | ||
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H.C. Wainwright & Co Yi Chen New York, U.S. |
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| 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. | ||
| Contacts | ||
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Nicox Gavin Spencer Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com |
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| Disclaimer | ||
| 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 section 3 of the “Rapport Annuel 2024” which is 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. | ||
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Nicox S.A. Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France T +33 (0)4 97 24 53 00 | ||
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