This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.

开始日期2023-12-12

申办/合作机构

Nicox Ophthalmics, Inc.

CTR20223164

/ Completed临床1期

0.1%NCX 470 滴眼液在中国健康志愿者中的全身药代动力学、安全性和耐受性研究

主要目的：评价0.1% NCX 470滴眼液单次和多次给药在中国健康受试者中的药代动力学特征次要目的：评价0.1% NCX 470滴眼液单次和多次给药在中国健康受试者中的安全性和耐受性

开始日期2023-02-22

申办/合作机构

Nicox Ophthalmics, Inc.

[+2]

NCT04630808

/ Active, not recruiting临床3期

A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.

开始日期2020-11-09

申办/合作机构

Nicox Ophthalmics, Inc.

100 项与 Bimatoprost grenod 相关的临床结果

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100 项与 Bimatoprost grenod 相关的转化医学

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100 项与 Bimatoprost grenod 相关的专利（医药）

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项与 Bimatoprost grenod 相关的文献（医药）

2024-12-01·Contemporary Clinical Trials

A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study

Article

作者: Mansberger, Steven L ; Hubatsch, Doug ; Fechtner, Robert ; Lopez, Krisi

PURPOSE:

To identify the optimal dose of NCX 470, a nitric oxide (NO)-donating bimatoprost, for comparison to latanoprost in a phase 3 trial for open-angle glaucoma (OAG) or ocular hypertension (OHTN) using an adaptive dose selection design.

PATIENTS AND METHODS:

In this prospective, multicenter trial, subjects were randomized 1:1:1 to NCX 470 0.065 %, NCX 470 0.1 %, or latanoprost 0.005 % dosed topically to both eyes once daily. After at least 30 subjects were assigned to each group, interim analysis was undertaken at 2 weeks and an independent committee selected the final NCX 470 dose for the full 12-week trial.

RESULTS:

The interim analysis included 103 subjects. The least-squares mean (95 % confidence interval [CI]) difference in diurnal intraocular pressure (IOP) was -1.51 mmHg (-2.88, -0.14) in the NCX 470 0.065 % group (p = 0.0308) and - 1.71 mmHg (-3.04, -0.38) in the NCX 470 0.1 % group (p = 0.0123), both favoring NCX 470 over latanoprost. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (p > 0.05). NCX 470 0.1 % was selected as the final dose and the NCX 470 0.065 % dose arm was terminated with subsequent subjects randomized 1:1 to NCX 470 0.1 % or latanoprost.

CONCLUSION:

Both concentrations of the NO-donating bimatoprost NCX 470 lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication.

2024-08-01·Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics

NCX 470 Reduces Intraocular Pressure More Effectively Than Lumigan in Dogs and Enhances Conventional and Uveoscleral Outflow in Non-Human Primates and Human Trabecular Meshwork/Schlemm's Canal Constructs

Article

作者: Unser, Andrea ; Ahmed, Feryan ; Hubatsch, Douglas A ; Impagnatiello, Francesco ; Torrejon, Karen Y ; Bastia, Elena ; Galli, Corinna ; Toris, Carol ; Fan, Shan

Purpose: To determine NCX 470 (0.1%) and Lumigan^® (bimatoprost ophthalmic solution, 0.01%-LUM) intraocular pressure (IOP)-lowering activity after single or repeated (5 days) dosing along with changes in aqueous humor (AH) dynamics. Methods: Ocular hypotensive activity of NCX 470 and LUM was compared with vehicle (VEH) in Beagle dogs using TonoVet^®. Non-human primates (NHP) and bioengineered three-dimensional (3D) human Trabecular Meshwork/Schlemm's Canal (HTM/HSC™) constructs exposed to transforming growth factor-β2 (TGFβ2) were used to monitor NCX 470 and LUM-induced changes in AH dynamics. Results: NCX 470 (30 μL/eye) showed greater IOP reduction compared with LUM (30 μL/eye) following single AM dosing [maximum change from baseline (CFB_max) = -1.39 ± 0.52, -6.33 ± 0.73, and -3.89 ± 0.66 mmHg (mean ± standard error of the mean) for VEH, NCX 470, and LUM, respectively]. Likewise, repeated 5 days daily dosing of NCX 470 resulted in lower IOP than LUM across the duration of the study (average IOP decrease across tests was -0.45 ± 0.22, -6.06 ± 0.15, and -3.60 ± 0.22 mmHg for VEH, NCX 470, and LUM, respectively). NCX 470 increased outflow facility (Cfl) in vivo in NHP (Cfl_VEH = 0.37 ± 0.09 μL/min/mmHg and Cfl_NCX470 = 0.64 ± 0.17 μL/min/mmHg) as well as in vitro (C_HTM/HSC) in HTM/HSC constructs (C_HTM/HSC__VEH = 0.47 ± 0.02 μL/min/mm²/mmHg and C_HTM/HSC__NCX470 = 0.76 ± 0.03 μL/min/mm²/mmHg). In addition, NCX 470 increased uveoscleral outflow (Fu_VEH = 0.62 ± 0.26 μL/min and Fu_NCX470 = 1.53 ± 0.39 μL/min with episcleral venous pressure of 15 mmHg) leaving unaltered aqueous flow (AHF_VEH = 2.03 ± 0.22 μL/min and AHF_NCX470 = 1.93 ± 0.31 μL/min) in NHP. Conclusions: NCX 470 elicits greater IOP reduction than LUM following single or repeated dosing. Data in NHP and 3D-HTM/HSC constructs suggest that changes in Cfl and Fu account for the robust IOP-lowering effect of NCX 470.

2024-08-01·AMERICAN JOURNAL OF OPHTHALMOLOGY

A Randomized, Controlled Comparison of NCX 470, a Nitric Oxide-Donating Bimatoprost, and Latanoprost in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The MONT BLANC Study

Article

作者: Mansberger, Steven ; Ziebell, Sara ; Lopez, Krisi ; Hubatsch, Doug ; Fechtner, Robert ; Mulaney, Jay ; Branch, James

PURPOSE:

To compare intraocular pressure (IOP)-lowering efficacy and safety of NCX 470, a nitric oxide (NO)-donating bimatoprost, to latanoprost in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

DESIGN:

Prospective, phase 3, randomized, adaptive dose-selection, double-masked, parallel-group trial.

METHODS:

691 subjects with OAG or OHT and unmedicated IOP ≥26 mmHg at 8AM, ≥24 mmHg at 10AM, and ≥22 mmHg at 4PM in the study eye were randomized to NCX 470 0.065%, NCX 470 0.1%, or latanoprost 0.005%. An interim analysis was performed to select the final dose of NCX 470. We evaluated noninferiority of NCX 470 versus latanoprost, based on IOP reduction from baseline at 8AM and 4PM at 2 weeks, 6 weeks, and 3 months.

RESULTS:

661 subjects were analyzed; IOP was significantly reduced at all on-treatment time points, with reductions ranging from 8.0 to 9.7 mmHg (P < .0001 at each time point) in the NCX 470 0.1% group. Mean IOP reductions were greater with NCX 470 0.1% than latanoprost 0.005% at all 6 time points and significantly greater (P < .05) at 4 of the 6 time points. The most common adverse event was conjunctival/ocular hyperemia.

CONCLUSION:

The NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with OAG or OHT at all 6 time points. With a dual mechanism of action that enhances both uveoscleral and trabecular outflow, NCX 470 could become an important first-line therapy for IOP reduction in glaucoma.

项与 Bimatoprost grenod 相关的新闻（医药）

2025-05-27

·EINPresswire

Nicox Announces up to €3 million in Milestone Payments from Kowa in 2025 as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan

Press Release Nicox Announces up to €3 million in Milestone Payments from Kowa in 2025 as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan Exclusive Japanese partner Kowa has received regulatory approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan Milestone payments from Kowa totaling €3 million expected to be received by Nicox in 2025 Extends Nicox’s cash runway until the end of 2025 May 27, 2025 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Japanese partner for NCX 470, Kowa, has received Clinical Trial Notification (equivalent of a U.S. Investigational New Drug, IND) approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan, triggering a €1 million milestone payment to Nicox. The clinical trials are expected to be initiated in H2 2025, which would trigger a second milestone payment of €2 million. “ This important achievement, which enables the initiation of phase 3 clinical development of NCX 470 for Japanese patients, demonstrates the effective collaboration established between the Kowa and Nicox teams and represents a significant advance by Kowa in the delivery of their accelerated development plan. As a result, we expect to receive a total of €3 million in development milestones from Kowa in 2025, extending our cash runway until at least the end of 2025 . ” said Gavin Spencer, Chief Executive Officer of Nicox. “ We congratulate our Japanese partner on the swift progress and look forward to continuing to work with them to bring NCX 470 to the Japanese market. ” Cash Runway Based on the current cash position, estimated revenue and anticipated milestone payments (including the Kowa milestones mentioned above) Nicox now estimates that it is financed until the end of 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. Key Future Milestones Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025 NCX 470 Phase 3 clinical trial in Japan: Initiation expected in H2 2025 Kowa NCX 470 License Nicox licensed the rights to develop and commercialize NCX 470 in Japan to Kowa in February 2024. Nicox may receive a further €7 million in development and regulatory milestones, up to €17.5 million in sales milestones and tiered royalties from 7% to 12% on net sales of NCX 470 in Japan. Kowa is responsible for all development, regulatory and commercialization costs for NCX 470 in Japan. About NCX 470 NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in Q3 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. 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 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 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) and is part of the CAC Healthcare index. For more information www.nicox.com Analyst coverage H.C. Wainwright & Co Yi Chen New York, U.S. 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 Nicox Gavin Spencer Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com 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. Nicox S.A. Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France T +33 (0)4 97 24 53 00 Attachment EN_NCX470JapanINDApprovalMay2025_PR_FINAL Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床3期

2025-05-14

·GlobeNewswire-Health Care

Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial

Press Release Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial Several aqueous humor parameters stimulated by nitric oxide were statistically significant or trended in favor of NCX 470; likewise those that respond to prostaglandin analogsEpiscleral venous pressure changes did not show a trend vs. placeboSafety profile is consistent with that of the first Phase 3 trial, Mont BlancNCX 470 intraocular pressure lowering efficacy and safety have already been demonstrated in the Phase 3 glaucoma trial, Mont BlancTimeline and planning for New Drug Application submissions remain on track May 14, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the results of the Whistler Phase 3b exploratory clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering in healthy volunteers and ocular hypertensive patients.“We believe that the outcomes in favor of NCX 470 in several trabecular meshwork aqueous humour dynamics parameters are due to nitric oxide. These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure.” said Doug Hubatsch, Chief Scientific Officer of Nicox. “The therapeutic characteristics of NCX 470 demonstrated in the Phase 3 program so far shows that we have an approvable and differentiated asset with a promising clinical profile. We look forward to announcing the safety and efficacy results from our ongoing Phase 3 trial, Denali, expected in the third quarter of this year.” The Whistler Phase 3b exploratory trial was a double-masked, placebo-controlled study designed to further our understanding of the action of NCX 470 ophthalmic solution, 0.1%, on various aqueous humor dynamic parameters in 18 healthy volunteers or subjects with ocular hypertension. Measurements were taken at baseline and after 8 days at 1 pm and, for some parameters, at 3 pm. Changes in aqueous humor flow rate trended towards significance vs. placebo (p=0.072). Outflow facility was positive at 1 pm (p=0.081), significant at 3 pm (p=0.001), as was the diurnal outflow (p=0.004). We believe this change is due to the effect of nitric oxide on the trabecular meshwork1. IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, whilst episcleral venous pressure did not show a notable trend. These findings support the dual mechanism of action for IOP lowering of NCX 470 through both the conventional (nitric oxide-stimulated) and the uveoscleral (prostaglandin-stimulated) pathways. The safety profile observed was consistent with that of the first Phase 3 trial, Mont Blanc. The Whistler trial was an exploratory trial and is not a requirement for the submission of New Drug Applications for NCX 470 and therefore does not impact the development timeline. The patient population in the Whistler trial was primarily normotensive healthy volunteers with mean baseline IOPs of 16.6 mmHg and 16.9 mmHg for NCX 470 and placebo treated patients, respectively. This is not the same patient profile as in the Phase 3 glaucoma program. Safety and efficacy have already been demonstrated in the first Phase 3 clinical trial, Mont Blanc. The results of the Mont Blanc trial are available on the Company’s website, www.nicox.com. About NCX 470NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in Q3 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. About NicoxNicox 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 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 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) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. 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 NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe 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.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 For examples of the role of nitric oxide on these parameters, see Dismuke WM, Liang J, Overby DR, Stamer WD. Concentration-related effects of nitric oxide and endothelin-1 on human trabecular meshwork cell contractility. Exp Eye Res. 2014;120:28–35 and Wiederholt M, Sturm A, Lepple-Wienhues A. Relaxation of trabecular meshwork and ciliary muscle by release of nitric oxide. Invest Ophthalmol Vis Sci. 1994;35:2515–2520. Attachment EN_WhistlerResultsMay2025_PR_FINAL

临床3期临床结果

2025-04-30

·GlobeNewswire-Health Care

Nicox Provides Full Year 2024 Financial Results

Press Release Nicox Provides Full Year 2024 Financial Results Nicox SA revenue of €7.9 million for full year 2024 Exceptional income of €13.7 million following the transfer of VYZULTA’s future revenue stream to Soleus CapitalNicox SA cash of €10.5 million on 31 December 2024 and the Company estimates it is currently financed into the fourth quarter of 2025 Topline results from NCX 470 second Phase 3 clinical trial, Denali, expected in the third quarter of 2025Ongoing discussions and business development outreach underway for NCX 470 U.S. partnership April 30, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided its financial results for the full year of 2024, as approved by the Board of Directors on 28 April 2025, and provided an update on key future milestones. Following the sale of the VYZULTA royalty in October 2024, the Company will no longer be providing quarterly revenue reports.“The achievements of 2024 by the Nicox team and our partners have allowed us to keep our product development on track and prepared to deliver two clinical readouts on NCX 470 in 2025. Our focus is now on ensuring that the Company is in the optimal position to exploit those results through ongoing partnership, business and corporate development discussions.” said Gavin Spencer, Chief Executive Officer of Nicox.Key Future Milestones Whistler Phase 3b clinical trial investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: Results are expected in May 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025.   Full Year 2024 Financial Results for Nicox SARevenue for the full year of 2024 was €7.9 million versus €6.9 million for the full year of 2023, including €3.0 million of VYZULTA royalties, recognized up to 30 June 2024 prior to the sale of the royalties to Soleus Capital, versus €6.6 million, consisting principally of royalty payments, for the full year of 2023. The revenue for 2024 also includes the upfront payment of €3.0 million from Kowa for the Japanese rights to NCX 470 and a non-cash amount of €1.5 million previously recognized as prepaid income. The revenue for 2024 also includes €0.2 million of internal rebilling compared to €0.3 million for 2023.Operating expenses for the full year of 2024 were €18.7 million compared to €24.2 million for the full year of 2023.Exceptional income in 2024 was €13.7 million compared to €0.1 million in 2023. In 2024 this revenue corresponds to the sale of the future milestones and royalty of VYZULTA to Soleus Capital.Nicox SA recorded a net loss of €22.4 million for year ended 31 December 2024, compared to a net loss of €20.9 million for the same period in 2023. The 2024 loss includes a non-cash amount of €27.1 million due to the impairment of an intercompany receivable held by Nicox SA on its U.S. affiliate Nicox Ophthalmics, Inc. The recoverability of this receivable depends on the future royalties the subsidiary is expected to receive from the commercialization of ZERVIATE. In accordance with French GAAP, the Company has adopted a prudent approach based on the most conservative sales forecast amongst other, more favorable scenarios. This led to a downward revaluation of the value of ZERVIATE following a new analysis for the Chinese market. This analysis highlighted developments that reduce the probability of achieving the initially anticipated annual peak sales target of US$100M. Since ZERVIATE is the sole revenue-generating asset in Nicox Ophthalmics, Inc., the intercompany receivable has consequently been impaired. The details concerning this impairment are given in Note 2.4.1 of the statutory accounts of the Company which are available on the Company’s website on the page “Financial and Regulatory Information”.As of 31 December 2024, Nicox SA had cash and cash equivalents of €10.5 million compared to €11.3 million as of 31 December 2023. The Company is currently funded until at least into the fourth quarter of 2025, based on focusing exclusively on the development of NCX 470. As of 31 December 2024, Nicox SA had financial debt of €15.1 million, consisting of €14.2 million in the form of a bond financing agreement with Kreos Capital (an affiliate of BlackRock), and a €0.9 million credit agreement guaranteed by the French State, and granted in the context of the COVID-19 pandemic. The Company is pursuing business development discussions, including the sale or license of certain assets, and exploring multiple other strategic options which could further extend the cash runway. The Company is evaluating all options for financing and will use the most appropriate at the time. About NicoxNicox 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 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 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) and is part of the CAC Healthcare index. For more information www.nicox.com Analyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. 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 NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe 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.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Income Statement (in thousands of euros)December 31, 2024December 31, 2023 Sales of services - misc. Chargeback3,315257Patent royalties4,5446,646 REVENUE7,8596,903 Reversals of depreciation, amortization, provisions, expense transfers45313Other income from ordinary activities574225 TOTAL OPERATING INCOME8,8867,141 Other purchases and external expenses(14,552)(18,406)Taxes, duties and similar payments (other than on income)(72)(99)Salaries and wages(2,092)(1,764)Social charges(660)(739)Depreciation and amortisation of tangible and intangible assets(17)(21)Provision of expenses for risks and charges(12)(122)Other expenses(1,335)(3,046) TOTAL OPERATING EXPENSES(18,740)(24,197) OPERATING PROFIT (LOSS)(9,854)(17,056) Other interest and similar income8451,099Income from participating interests3,050-Reversal of provisions and transfer of expenses1339Foreign exchange gains371117 TOTAL FINANCIAL INCOME4,2791,255 Amortization, depreciation and financial provisions(27,776)(3,743)Interest and similar expenses(1,557)(1,633)Foreign exchange loss(45)(244) TOTAL FINANCIAL EXPENSES(29,378)(5,621) FINANCIAL PROFIT (LOSS)(25,099)(4,366) PRE-TAX LOSS(34,952)(21,422) Exceptional income on management operations13,74363Exceptional income on capital operations3- EXCEPTIONAL INCOME13,74663 Exceptional charges on management operations(2)-Exceptional charges on capital operations(922)- EXCEPTIONAL EXPENSES(924)- EXCEPTIONAL INCOME (LOSS)12,82263 Research Tax Credit(259)478 NET PROFIT & LOSS(22,390)(20,881) Balance sheet (in thousands of euros)December 31, 2024December 31, 2023 ASSETS Intangible assets1324Property, plant and equipment1126Financial assets7251,805 TOTAL FIXED ASSETS7491,855 Trade receivables and related accounts1,6433,424Other receivables9,34934,323Cash and cash equivalents10,54211,259Prepaid expenses1,515886 TOTAL CURRENT ASSETS23,04949,893 Unrealized foreign exchange losses and valuation differences - Assets1313Bond redemption premiums6101,218 TOTAL REGULARISATION ACCOUNTS6231,231 TOTAL ASSETS24,42152,980 LIABILITIES Issued Capital69250,170Share premium533,549529,478Retained earnings(508,438)(537,354)Net loss for the period(22,390)(20,881) TOTAL SHAREHOLDERS' EQUITY3,41321,413 Provisions for liabilities1313Provisions for charges268700 TOTAL PROVISIONS FOR LIABILITIES AND CHARGES281713 Loans and debts from lending institutions15,06420,895Loans and other financial debts824,258Accounts payable and related accounts1,6512,499Tax and social security liabilities603648Deferred income7351,919 TOTAL LIABILITIES18,13530,218 Unrealized foreign exchange gains and valuation differences - Liabilities2,592635 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY24,42152,980 Attachment EN_FY2024_PR_FINAL

财报临床3期引进/卖出

100 项与 Bimatoprost grenod 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
高眼压症	临床3期	中国	苏州欧康维视生物科技有限公司	2022-01-30
开角型青光眼	临床3期	美国	Nicox Ophthalmics, Inc.	2020-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05938699 (Whistler, GlobeNewswire) 人工标引	临床3期	高眼压症	18	NCX 470	淵憲鹹繭繭淵範鬱範觸(淵糧衊鑰願遞製網築艱) = Changes in aqueous humor flow rate trended towards significance vs. placebo (p=0.072). Outflow facility was positive at 1 pm (p=0.081), significant at 3 pm (p=0.001), as was the diurnal outflow (p=0.004). 廠壓鏇積壓淵憲簾願廠 (範壓構齋簾鑰憲繭顧襯 )	积极	2025-05-14
				Placebo
NCT04445519 (MONT BLANC, Literature) 人工标引	临床3期	开角型青光眼 \| 高眼压症	103	NCX 470 0.065 %	窪鹹醖鏇廠醖簾壓鑰衊(鏇範製製鬱積鬱鬱餘夢) = The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (p > 0.05). 衊鏇淵選製齋築顧糧鑰 (簾鑰衊壓鑰膚簾憲膚壓 )	积极	2024-12-01
				NCX 470 0.1 %
ARVO2023	N/A	氧自由基损伤	-	NCX 470 (0.1% bid)	襯壓糧鏇鹽襯鏇鹹蓋鹹(觸糧憲選襯選獵願窪齋) = 蓋糧積壓糧鹹餘網餘選繭顧鏇範廠壓醖窪鹽淵 (糧製簾齋淵簾鹹糧選觸 )	-	2023-04-23
				Lumigan® (bimatoprost 0.01%, ophthalmic solution)	襯壓糧鏇鹽襯鏇鹹蓋鹹(觸糧憲選襯選獵願窪齋) = 構鹽鹽壓製獵淵遞齋願繭顧鏇範廠壓醖窪鹽淵 (糧製簾齋淵簾鹹糧選觸 )
NCT03657797 (Dolomites, CTgov)	临床2期	开角型青光眼	656	NCX 470 (NCX 470 0.021%)	積壓鏇鹽遞鏇夢憲蓋鹹(淵網衊選鑰艱夢觸網製) = 壓醖積遞糧鑰選鹹鹹衊構蓋範積築獵製鹽積艱 (繭鹹夢鑰鹹築鹽遞鑰簾, 2.606) 更多	-	2022-12-08
				NCX 470 (NCX 470 0.042%)	積壓鏇鹽遞鏇夢憲蓋鹹(淵網衊選鑰艱夢觸網製) = 醖襯艱醖淵齋遞網鏇窪構蓋範積築獵製鹽積艱 (繭鹹夢鑰鹹築鹽遞鑰簾, 2.511) 更多
NCT04445519 (Mont Blanc, Corporate Publications) 人工标引	临床3期	青光眼	691	NCX 470	範壓齋襯願獵構醖襯願(鏇鹹憲獵餘衊餘願鹽蓋) = 餘築鹹選齋簾簾遞願艱積遞鑰醖齋鏇壓夢獵繭 (壓鹹積蓋淵選築廠積顧 ) 更多	非劣	2022-10-31
				Latanoprost	範壓齋襯願獵構醖襯願(鏇鹹憲獵餘衊餘願鹽蓋) = 壓憲餘繭鑰鏇鑰膚襯糧積遞鑰醖齋鏇壓夢獵繭 (壓鹹積蓋淵選築廠積顧 ) 更多
ARVO2022	N/A	-	-	NCX 470 0.1%	淵壓壓觸壓觸淵鑰齋膚(鏇醖觸鹽繭製艱顧鏇衊) = 獵憲廠選簾繭願遞範製鏇構網衊艱鬱淵廠網糧 (衊簾廠鏇繭襯鬱廠蓋餘 ) 更多	-	2022-05-01
				Vehicle	淵壓壓觸壓觸淵鑰齋膚(鏇醖觸鹽繭製艱顧鏇衊) = 顧築憲餘積憲鏇築願艱鏇構網衊艱鬱淵廠網糧 (衊簾廠鏇繭襯鬱廠蓋餘 ) 更多
NCT03657797 (Dolomites, AAO2020)	临床2期	低眼压	433	NCX 470 0.021%	蓋壓糧襯壓醖遞窪鏇積(製觸廠夢積簾襯廠鹽製) = The most common adverse event was conjunctival hyperemia. There were no treatment-related serious adverse events or treatment-related systemic adverse events 觸鏇繭衊顧願醖鏇醖獵 (壓艱廠構膚選壓鑰遞鏇 )	积极	2020-11-13
				NCX 470 0.065%
NCT03657797 (Dolomites, GlobeNewswire) 人工标引	临床2期	青光眼	433	NCX-470	構製製繭鑰獵顧鏇蓋艱(積獵選糧遞醖蓋淵願淵) = 構夢簾齋獵選積壓憲鑰觸選積膚鑰膚構醖醖廠 (餘鬱鏇積願艱鹹糧襯築 ) 更多	积极	2019-10-02
				Latanoprost	構製製繭鑰獵顧鏇蓋艱(積獵選糧遞醖蓋淵願淵) = 鏇餘衊膚鑰憲簾願獵衊觸選積膚鑰膚構醖醖廠 (餘鬱鏇積願艱鹹糧襯築 ) 更多