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

/ Completed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: Torrejon, Karen Y. ; Unser, Andrea ; Ahmed, Feryan ; Torrejon, Karen Y ; Impagnatiello, Francesco ; Hubatsch, Douglas A ; Bastia, Elena ; Hubatsch, Douglas A. ; 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.

124

项与 Bimatoprost grenod 相关的新闻（医药）

2026-04-30

·BioSpace

Nicox Provides Full Year 2025 Financial Results and Corporate Update

Press Release Nicox Provides Full Year 2025 Financial Results and Corporate Update Revenue of €16.8 million (€7.9 million in 2024) Net loss significantly reduced to €2.4 million (€22.4 million in 2024) NCX 470 U.S. New Drug Application (NDA) submission on track for summer 2026, with associated milestone payment Regulatory milestones anticipated to extend cash runway beyond 2027 April 30, 2026 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced its financial results for the full year of 2025, as approved by the Board of Directors on 29 April 2026, and provided an update on key future milestones. “2025 marked a pivotal turning point for Nicox,” said Gavin Spencer, Chief Executive Officer of Nicox. “We have significantly strengthened our financial position, reduced our net loss and eliminated secured debt, removing a number of long-term obligations on the Company. Our priorities are clear for 2026: supporting the submissions of the NCX 470 New Drug Applications in the U.S. and China along with our partners, which are expected to facilitate a new future long-term revenue stream for the company, and on exploring strategic opportunities to maximise our value . ” Key Future Milestones NCX 470 NDA submission in the United States: expected summer 2026. NCX 470 NDA submission in China: expected shortly after submission in the U.S. NCX 470 Phase 3 clinical program in Japan: initiated summer 2025. Full Year 2025 Financial Results for Nicox SA The Financial Statements for 2025 are provided in the appendix to this Press Release. Revenue for the full year of 2025 was €16.8 million versus €7.9 million for the full year 2024, principally consisting of milestone payments from Kowa related to the NCX 470 license agreements outside China and Southeast Asia. The revenue for 2025 also includes €1.2 million of intercompany billings compared to €0.2 million for 2024. Revenue in 2024 included €3.0 million of VYZULTA royalties, recognized up to 30 June 2024 prior to their sale to Soleus Capital; a €3.0 million upfront payment from Kowa for the Japanese rights to NCX 470 and a non-cash amount of €1.5 million previously recognized as deferred income. Operating expenses for the full year 2025 were €14.3 million compared to €18.7 million for the full year 2024, reflecting the completion of the second pivotal Phase 3 trial (Denali) for NCX 470, with initial results released in August 2025. No exceptional income was recognized in 2025 compared to €13.7 million recorded in 2024 following the sale of the future milestones and royalty of VYZULTA to Soleus Capital. Nicox recorded a net loss of €2.4 million in 2025, compared to a net loss of €22.4 million in 2024, reflecting a significant improvement driven by higher revenues, primarily from milestone payments, and lower operating expenses following the completion of the Phase 3 Denali trial for NCX 470. As of 31 December 2025, Nicox had cash and cash equivalents of €4.1 million compared to €10.5 million as of 31 December 2024. Including the regulatory milestone payments expected for NCX 470 and assuming a standard 12-month review period after the NDA filing, the Company estimates it is funded beyond 2027. The Company remains committed to cost control and optimizing resource allocation to support our strategic objectives. If any of the assumptions around estimated income or costs change, this may impact the cash runway. The Company is pursuing business development discussions and continuing to evaluate a number of strategic growth opportunities, including collaborations or business combinations. Potential proceeds from existing warrants are not included in the above cash runway calculation. Details of the warrants from the June 2024 financing are given in our Q&A section of . Post-reporting period events The remaining €1.0 million from the financing announced in our Press Release of January 5, 2026, has just been released. As previously anticipated, the Company has decided, with the holders’ agreement, to convert the ordinary bonds established in January 2026 into convertible bonds (OCs) of the same nature and with the same characteristics as the OCs issued in January 2026, and to which they have been assimilated 1 . The ordinary bonds were converted into OCs pursuant to the decision of the Board of Directors taken at its meeting of 29 April 2026. 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 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 2025 ” which are available on Nicox’s website ( ). 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 Income Statement (in thousands of euros) December 31, 2025 December 31, 2024 Net sales (revenue) 16,771 7,859 Reversals of depreciation, impairment and provisions 2,000 444 Proceeds from disposals of intangible and tangible fixed assets 1 - Other income 176 574 OPERATING INCOME 18,948 8,877 Other purchases and external expenses (10,233) (14,552) Taxes, duties and similar payments (other than on income) (44) (72) Salaries (1,220) (2,092) Social charges (580) (651) Depreciation and impairment of intangible and tangible fixed assets (10) (17) Provision expense (44) (12) Net book value of disposed intangible and tangible fixed assets (2,003) - Other expenses (188) (1,335) OPERATING EXPENSES (14,322) (18,731) OPERATING PROFIT (LOSS) 4,626 (9,854) Income from equity investments - 3,050 Income from other long-term securities and receivables 240 244 Other interest and similar income 506 601 Reversals of impairment and provisions 16,152 13 Foreign exchange gains 47 371 FINANCIAL INCOME 16,945 4,279 Amortization, depreciation and financial provisions (20,363) (27,776) Interest and similar expenses (2,950) (1,557) Foreign exchange loss (671) (45) FINANCIAL EXPENSES (23,984) (29,378) FINANCIAL PROFIT (LOSS) (7,039) (25,099) PRE-TAX INCOME (LOSS) (2,413) (34,952) Exceptional income on management operations - 13,743 Exceptional income on capital operations - 3 EXCEPTIONAL INCOME - 13,746 Exceptional charges on management operations - (2) Exceptional charges on capital operations - (922) EXCEPTIONAL EXPENSES - (924) EXCEPTIONAL INCOME (LOSS) - 12,822 Research Tax Credit - (259) NET PROFIT & LOSS (2,413) (22,390) Balance sheet (in thousands of euros) December 31, 2025 December 31, 2024 ASSETS Intangible assets 6 13 Property, plant and equipment 5 11 Financial assets 139 725 TOTAL FIXED ASSETS 150 749 Trade receivables and related accounts 936 1,643 Other receivables 2,268 9,349 Prepaid expenses 1,280 1,515 Cash and cash equivalents 4,147 10,542 TOTAL CURRENT ASSETS 8,631 23,049 Unrealized foreign exchange losses and valuation differences - Assets 1,592 13 Bond redemption premiums - 610 TOTAL REGULARISATION ACCOUNTS 1,592 623 TOTAL ASSETS 10,373 24,421 LIABILITIES Issued Capital 884 692 Share premium 538,377 533,549 Retained earnings (530,828) (508,438) Net loss for the period (2,413) (22,390) TOTAL SHAREHOLDERS' EQUITY 6,020 3,413 Provisions for liabilities 1,591 13 Provisions for charges 312 268 TOTAL PROVISIONS FOR LIABILITIES AND CHARGES 1,903 281 Loans and debts from lending institutions 337 15,064 Loans and other financial debts 67 82 Accounts payable and related accounts 675 1,651 Tax and social security liabilities 751 603 Deferred income 617 735 TOTAL LIABILITIES 2,447 18,135 Unrealized foreign exchange gains and valuation differences - Liabilities 3 2,592 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 10,373 24,421 1 For illustrative purposes, if all the convertible bonds announced today were converted based on the Nicox share price at the close market on April 29, 2026 and of outstanding shares as of April 29, 2026, a shareholder holding 1.00% of Nicox's share capital prior to the transaction would see their holding reduced to 0.97% of the share capital on a non-diluted basis and to 0.74% on a fully diluted basis (taking into account existing dilutive instruments). Attachment EN_FY2025_PR_FINAL

财报临床3期引进/卖出

2026-04-20

·GlobeNewswire-Health Care

Reminder: Last Exercise Day for Nicox June 2024 Warrants is June 19, 2026

Press Release Reminder: Last Exercise Day for Nicox June 2024 Warrants is June 19, 2026April 20, 2026 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today reminds holders of the warrants issued in June 2024 as part of the Company’s equity offering with preemptive rights that these warrants will expire on June 20, 2026. June 20 being a Saturday, the last effective date for trading or exercising the warrants will be Friday, June 19, 2026, close of market day.Reminder of the main features of the warrants Listing of the warrants: The warrants are listed on Euronext Growth ParisISIN code: FR001400QEQ3Exercise period: from June 21, 2024 to June 19, 2026 (close of market)Exercise parity: 5 warrants give the holder the right to subscribe to 2 new Nicox sharesExercise price: €0.275 per new share Any warrants not exercised by the close of market day on Friday, June 19, 2026 will automatically expire, will no longer be exercisable and will no longer have any value. As of March 31, 2026, 10,022,595 June 2024 warrants remain outstanding and exercisable, representing a potential issuance of 4,009,038 new shares upon exercise. For illustrative purposes, if all outstanding June 2024 warrants were exercised, a shareholder holding 1% of the capital (calculated on the basis of the number of outstanding shares as of March 31, 2026) prior to the exercise of the outstanding warrants would hold 0.96% of the capital on a non-diluted basis and 0.75% on a fully diluted basis. Exercise procedureTo exercise their warrants, holders should contact the financial intermediary holding their securities account (bank or broker). Details of the warrants from the June 2024 financing are given in the Q&A section of our website: www.nicox.com.About NicoxNicox 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.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.comDisclaimerThe 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” and in section 4 of the “Rapport semestriel 2025” which are 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 Attachment EN_WarrantsReminder_FINAL

2026-03-18

·动脉网

【里程碑】眼压最大降幅10mmHg！青光眼双重机制新药中美NDA在即

近日，法国眼科生物技术公司Nicox SA（巴黎泛欧交易所代码：FR0013018124，ALCOX，下称Nicox）在美国青光眼学会年会（AGS 2026）上公布了其主要候选药物NCX 470的III期临床研究最新数据。结果显示，在关键性DENALI试验中，0.1%浓度的NCX 470在治疗开角型青光眼或高眼压症患者时表现出显著且持续的降眼压效果，与基线相比最大降幅达到10 mmHg，并在所有评估时间点达到对拉坦前列素（Latanoprost）的非劣效性终点。 01 从单通路到双通路的机制创新青光眼是一种以视神经损伤为核心特征的慢性眼病，而升高的眼内压（IOP）是目前唯一被证实可以通过治疗有效控制的危险因素。因此，几乎所有青光眼药物研发的核心目标都集中在一个方向：更有效地降低眼内压。当前临床一线药物主要是前列腺素类似物，例如拉坦前列素、比马前列素（Bimatoprost）、曲伏前列素（Travoprost）等，这些药物通过增加葡萄膜-巩膜通路（uveoscleral outflow）促进房水外流，从而降低眼内压。凭借每日一次给药、疗效稳定以及安全性成熟等优势，前列腺素类药物已经成为全球青光眼治疗的标准一线方案。然而，其降压能力通常在25%–30%左右。对于相当一部分患者而言，这一降压幅度仍不足以达到目标眼压，因此往往需要加用第二种甚至第三种药物。而多一种药物，就是给患者药物依从性上难度。 NCX 470的设计理念正是针对这一临床痛点。该药物本质上是比马前列素与一氧化氮供体（NO-donor）的结合分子。滴眼后，药物在眼部组织中代谢释放两种活性成分。一方面，比马前列素部分延续了传统前列腺素类药物的作用机制，促进葡萄膜-巩膜通路房水外流；另一方面，释放的一氧化氮则能够松弛小梁网和平滑肌结构，降低Schlemm管（施莱姆氏管）阻力，从而增强小梁网通路（trabecular outflow）。换句话说，NCX 470同时作用于两条主要房水外流通道，实现所谓的“双通路降压”。这一策略在理论上具有明显优势。传统前列腺素类药物主要作用于葡萄膜通路，而青光眼患者房水外流受阻的主要位置恰恰往往在小梁网。通过一氧化氮介导的小梁网松弛，NCX 470 有望在保证安全性的同时进一步增强降眼压效果。事实上，一氧化氮供体技术在眼科领域并非完全陌生。公司此前上市的另一款产品Vyzulta®便采用类似机制。但NCX 470在分子设计上选择了比马前列素作为前列腺素骨架，这一选择本身就具有潜在优势，因为比马前列素在临床实践中普遍被认为降压能力略强于拉坦前列素。因此，可以说NCX 470的核心目标明确：在保持前列腺素类药物良好耐受性的基础上，打造更强降眼压能力的单药治疗。 02 眼压最大降幅达到10 mmHg NCX 470的关键III期研究主要包括MONT BLANC与DENALI两项全球多中心临床试验。这些研究将NCX 470与标准剂量的比马前列素进行直接比较，以评估其降眼压能力。试验入组患者主要为原发性开角型青光眼或高眼压症患者，这也是目前降眼压药物最常见的治疗人群。美国受试者的基线人口统计学特征与眼部特征 DENALI是一项随机、双盲、多中心III期临床研究，旨在评估NCX 470在开角型青光眼（OAG）或高眼压症（OHT）患者中的疗效与安全性。该研究由美国杜克大学医学中心的Sanjay Asrani 博士在大会上进行报告。美国亚组III期denali试验的研究设计，主要疗效终点评估时间点为第2周、第6周及第3个月研究结果显示，0.1% NCX 470在所有主要评估时间点均达到相对于0.005%拉坦前列素的预设非劣效性标准。与此同时，在6个时间点中的3个时间点，NCX 470 实现了统计学意义上的更大眼压下降幅度。第2周、第6周及第3个月时，NCX 470与拉坦前列素在眼压降低方面的均值差异从整体疗效表现来看，NCX 470在研究期间展现出快速、强效且持续的降眼压作用，更重要的是，与基线相比最大降幅达到10 mmHg。这一降压幅度在目前单药治疗方案中具有较强竞争力。美国受试者中使用NCX 470 0.1%与使用拉坦前列素的平均眼压随时间变化在安全性方面，NCX 470整体耐受性与前列腺素类药物相似。最常见的不良反应包括结膜充血和轻度眼部刺激，但总体发生率处于可接受范围内。相比之下，一些新机制药物（例如Rho激酶抑制剂）往往会出现较高比例的结膜充血，从而影响患者依从性。从临床角度来看，这一点尤为重要。青光眼是一种需要长期甚至终身用药的慢性疾病，任何影响患者依从性的因素都会在真实世界中放大。因此，NCX 470的临床数据不仅展示了更强的降压能力，同时也维持了前列腺素类药物成熟的安全性特征。这种“疗效增强但安全性不显著恶化”的平衡，正是改良型眼科药物成功的重要因素。 03 中美NDA申报在即，FDA反馈总体积极除临床数据外，Nicox近期还披露了NCX 470的监管进展。2026年2月16日，公司宣布已与美国FDA完成新药申请（NDA）递交前会议。根据FDA提供的书面反馈，监管机构认为目前已有的临床数据以及公司计划提交的NDA内容和格式总体符合申报要求。FDA仅建议补充一项药代动力学（PK）数据，该数据将来自日本开展的一项小规模临床研究。 Nicox表示，该补充数据不会影响整体申报时间表，公司仍计划在2026年夏季向FDA提交 NCX 470的NDA。在商业合作方面，Nicox已将NCX 470的全球主要市场商业化权利授权给日本制药企业 Kowa Company。在中国及部分亚洲地区，该产品的权益则授权给了欧康维视，目前中国正在进行III期临床。根据协议，若产品成功上市，Nicox有望获得里程碑付款以及未来销售收入分成。青光眼是全球最主要的致盲性疾病之一。据流行病学研究估计，到2040年全球青光眼患者数量可能超过1亿人。庞大的患者基数，使得降眼压药物市场长期保持稳定规模。目前全球青光眼药物市场规模约为70–80亿美元。其中，前列腺素类药物仍占据最大的市场份额。与此同时，在这一市场中，大量核心药物已经专利到期，仿制药竞争激烈，价格普遍较低。因此，新药想要获得商业成功，往往需要在临床定位上形成明确差异，而不是单纯依靠“全新机制”。 NCX 470的潜在定位正是如此。它很可能不会取代传统PGA（前列腺素衍生物）作为首选初始治疗，而是成为传统前列腺素单药治疗后的升级方案。从长期来看，NCX 470的商业潜力主要取决于其在真实世界中的降压效果是否能够持续优于传统前列腺素类药物，此外，就是医生是否愿意将其作为“强化型单药”纳入治疗路径。如果这两点能够得到保证，NCX 470有望在青光眼药物市场中占据稳定份额。关于Nicox Nicox SA 是一家总部位于法国的跨国眼科公司，专注于利用其一氧化氮供体技术来开发眼科药物，提供维持视力和改善眼部健康的创新方案。该公司处于临床研发阶段，核心产品包括用于治疗青光眼的 NCX 470，并有已商业化的产品VYZULTA®和ZERVIATE®，后者已于2024年9月19日在中国获批上市。 VYZULTA®，0.024%，是一种一氧化氮供体前列腺素F2a类似物，适用于降低开角型青光眼或高眼压患者的眼压。该产品在全球范围内独家授权给全球领先的眼科健康公司Bausch + Lomb。VYZULTA®已在包括美国在内的超15个国家完成商业化，并且在其他多个国家获得批准。Nicox已于2024年10月将VYZULTA的版税收入出售给Soleus Capital。 ZERVIATE®，0.24%，适用于治疗过敏性结膜炎引起的眼痒，由公司的合作伙伴Harrow负责在美国的商业化。此外，在中国，则由欧康维视销售。公司已经将ZERVIATE独家授权给欧康维视，后者正负责产品在中国及大部分东南亚市场的开发和商业化。在研管线NCX 1728是一种处于临床前研究阶段的“一氧化氮供体型磷酸二酯酶-5 (PDE5) 抑制剂”类新药。和NCX 470一样，它具有双重作用机制：释放一氧化氮和抑制 PDE5，从而增强并延长降低眼压和神经保护的作用，有望治疗青光眼和视网膜疾病。如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。动脉网，未来医疗服务平台

临床3期临床2期临床结果

100 项与 Bimatoprost grenod 相关的药物交易

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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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04630808 (Denali, NEWS) 人工标引	临床3期	开角型青光眼 \| 高眼压症	696	NCX 470 0.1%	鏇艱觸廠積糧構獵鹹醖(獵艱築網餘鏇鹹獵鑰憲) = Mean IOP reductions from baseline ranged from 7.9 to 10.0 mmHg with NCX 470 0.1% compared to 7.1 to 9.8 mmHg with latanoprost, measured at 8 AM and 4 PM across week 2, week 6, and month 3 visits. In a prespecified secondary analysis, NCX 470 achieved statistically significant superiority (p<0.05) at 3 of 6 timepoints, and numerically greater reductions at 5 of 6 timepoints, with differences up to 0.8 mmHg in favor of NCX 470. 網蓋醖獵製築襯願獵醖 (繭鬱願憲網蓋築廠觸齋 ) 更多	非劣	2025-08-21
				Latanoprost 0.005%
NCT04445519 (MONT BLANC, CTgov)	临床3期	开角型青光眼	691	NCX 470 0.1% (initial phase of trial) (NCX 470 0.1%)	選襯廠廠製網艱衊壓鹹(繭鏇淵範蓋築廠簾壓憲) = 襯糧廠積鏇艱糧製鑰積築廠壓範艱獵壓製願憲 (窪衊簾獵鏇願鏇繭淵艱, 3.443) 更多	-	2025-05-30
				Latanoprost (Latanoprost 0.005%)	選襯廠廠製網艱衊壓鹹(繭鏇淵範蓋築廠簾壓憲) = 餘製構願網蓋顧憲鏇鹹築廠壓範艱獵壓製願憲 (窪衊簾獵鏇願鏇繭淵艱, 3.349) 更多
NCT05938699 (Whistler, GlobeNewswire) 人工标引	临床3期	高眼压症	18	NCX 470	選餘夢窪膚遞糧願衊鬱(襯鏇選鏇艱壓鏇襯製艱) = 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). 鹹範齋觸積獵鑰衊構醖 (鏇製憲網憲願憲選築觸 )	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 470NCX 470 0.065 %	築範衊鑰窪夢積繭艱淵(艱範糧積艱積獵積積鹽) = 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). 蓋醖鏇膚餘蓋衊醖襯窪 (範構觸憲鬱襯艱衊醖遞 )	积极	2024-12-01
				NCX 470NCX 470 0.1 %
NCT03657797 (Dolomites, CTgov)	临床2期	开角型青光眼	656	NCX 470 (NCX 470 0.021%)	積壓壓鏇餘夢繭膚獵鏇(襯鑰醖憲獵鹹範醖餘膚) = 廠構選鏇憲鏇鬱構範觸壓構壓鹹範憲艱範製衊 (壓範顧鹹簾艱獵襯蓋夢, 2.606) 更多	-	2022-12-08
				NCX 470 (NCX 470 0.042%)	積壓壓鏇餘夢繭膚獵鏇(襯鑰醖憲獵鹹範醖餘膚) = 鹽築襯觸壓鑰憲願醖觸壓構壓鹹範憲艱範製衊 (壓範顧鹹簾艱獵襯蓋夢, 2.511) 更多
NCT04445519 (Mont Blanc, Corporate Publications) 人工标引	临床3期	青光眼	691	NCX 470	淵積顧網鹹製構鏇廠觸(憲膚蓋醖淵製齋願餘顧) = 鹹襯簾餘壓願襯願鬱衊壓蓋餘構積糧網夢鏇構 (繭鏇窪襯顧窪淵淵觸選 ) 更多	非劣	2022-10-31
				Latanoprost	淵積顧網鹹製構鏇廠觸(憲膚蓋醖淵製齋願餘顧) = 簾鏇繭餘遞齋襯壓簾網壓蓋餘構積糧網夢鏇構 (繭鏇窪襯顧窪淵淵觸選 ) 更多
NCT03657797 (Dolomites, AAO2020)	临床2期	低眼压	433	NCX 470 0.021%	鑰襯積蓋鬱壓遞鹽廠廠(齋鬱夢醖鹹製鏇夢觸襯) = The most common adverse event was conjunctival hyperemia. There were no treatment-related serious adverse events or treatment-related systemic adverse events 醖艱膚構艱襯繭獵膚顧 (糧夢廠積繭顧壓襯鹽構 )	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	網餘鹹淵衊壓憲蓋構壓(蓋製膚蓋廠網鹽襯廠顧) = 衊鏇襯壓構鹽築繭醖範簾選鑰鏇觸夢繭淵製壓 (淵醖構網簾憲鹹壓構糧 ) 更多	积极	2019-10-02
				Latanoprost	網餘鹹淵衊壓憲蓋構壓(蓋製膚蓋廠網鹽襯廠顧) = 築蓋壓獵蓋範顧艱醖衊簾選鑰鏇觸夢繭淵製壓 (淵醖構網簾憲鹹壓構糧 ) 更多