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.

Start Date12 Dec 2023

Sponsor / Collaborator

Nicox Ophthalmics, Inc.

CTR20223164

/ CompletedPhase 1

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

[Translation] Study on the systemic pharmacokinetics, safety and tolerability of 0.1% NCX 470 eye drops in Chinese healthy volunteers

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

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of single and multiple administrations of 0.1% NCX 470 eye drops in healthy Chinese subjects Secondary objective: To evaluate the safety and tolerability of single and multiple administrations of 0.1% NCX 470 eye drops in healthy Chinese subjects

Start Date22 Feb 2023

Sponsor / Collaborator

Nicox Ophthalmics, Inc.

[+2]

NCT04630808

/ CompletedPhase 3

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.

Start Date09 Nov 2020

Sponsor / Collaborator

Nicox Ophthalmics, Inc.

100 Clinical Results associated with Bimatoprost grenod

100 Translational Medicine associated with Bimatoprost grenod

100 Patents (Medical) associated with Bimatoprost grenod

Literatures (Medical) associated with Bimatoprost grenod

01 Dec 2024·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

Author: 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.

01 Aug 2024·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

Author: Unser, Andrea ; Torrejon, Karen Y. ; Impagnatiello, Francesco ; Hubatsch, Douglas A ; Torrejon, Karen Y ; Ahmed, Feryan ; 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.

01 Aug 2024·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

Author: 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.

100

News (Medical) associated with Bimatoprost grenod

23 Oct 2025

·www.globenewswire.com

Nicox Provides First Half 2025 Financial Results

Press Release Nicox Provides First Half 2025 Financial Results New Drug Application (NDA) submissions for NCX 470 expected in 2026 in the U.S. and ChinaCompany believes that it can finance its existing operations for at least 12 months and expects to fully repay existing financial debts in 2026 October 23, 2025 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the financial results for Nicox SA (the “Company”) for the first half of 2025, as approved by the Board of Directors on October 22, 2025, and provided an update on key future milestones. “Our recent licensing payments, financing and careful cost control have positioned us with over 12 months of operational runway and the ability to repay all existing financial debts. In addition, NCX 470 marketing authorisation preparation and filing costs are taken on by our partners, who will also be responsible for the commercialisation of NCX 470 worldwide in the over $7 billion glaucoma market. This is a significant achievement for the Company, allowing us to move forward on a solid footing. Our double focus is now on both accompanying our partners in obtaining regulatory approval for NCX 470 and exploring future growth opportunities for the company.” said Gavin Spencer, Chief Executive Officer of Nicox. Key Future Milestones NCX 470 NDA submission in the United States: expected in H1 2026.NCX 470 NDA submission in China: expected shortly after submission in the U.S. NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025. Managed and financed by Kowa. Subsequent eventsThe Company received license payments in August and September totalling €12.5 million relating to the signature of the NCX 470 license to Kowa and the Denali clinical trial results, in addition to €2 million related to the initiation of clinical trails on NCX 470 in Japan. Part of these payments has been used to reduce the Company’s financial debt, which amounted to €7.4 million as of 30 September 2025 and which is expected to be fully repaid in 2026.First Half 2025 Financial Results for Nicox SA Revenue for the first half of 2025 was €1.5 million (consisting principally of license payments) versus €6.1 million (including €3.1 million of net royalty payments and a license payment of €3.0 million) for the first half of 2024. The decrease mainly reflects the sale of the VYZULTA royalty stream to Soleus in the second half of 2024.Operating expenses for the first half of 2025 were €6.8 million compared to €10.1 million for the first half of 2024. The decrease primarily reflects lower payroll expenses following the cost reductions initiated in 2024, and the end of Pfizer royalty payments after the sale of the VYZULTA royalties to Soleus.Net loss for the six months ended June 30, 2025 was €8.9 million, compared to a net loss of €4.3 million for the same period in 2024. The net loss for the first half of 2025 includes a €3.0 million foreign exchange loss on US dollar-denominated receivables and cash, versus an insignificant amount in 2024.As of June 30, 2025, Nicox SA had cash and cash equivalents of €5.7 million (excluding receipt of €12.5 million of license payments and partial debt repayment after the reporting period, as set out above) as compared with €10.5 million as of December 31, 2024. Based on the expected upcoming milestones and the repayment of all existing financial debts, the Company is financed for at least 12 months. The Company remains committed to cost control and optimizing resource allocation while maintaining the capabilities required to support our strategic objectives. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company.As of June 30, 2025, Nicox SA had financial debt of €14.8 million as compared with €15.1 million as of December 31, 2024. Only the figure related to the cash position and the debt of Nicox SA as of December 31, 2024, is audited; all other figures in this press release are non-audited. 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.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” 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 Balance sheet(in thousands of euros)June 30, 2025December 31, 2024 ASSETS Intangible fixed assets1013Tangible fixed assets911Financial fixed assets703725 FIXED ASSETS722749 Trade receivables and related accounts1,0471,643Other receivables3,5269,349Cash assets5,70510,542Prepaid expenses1,7961,515CURRENT ASSETS12,07423,049 Unrealized foreign exchange losses and valuation differences – Assets1,50813Loan redemption premiums306610TOTAL REGULARISATION ACCOUNTS1,814623 TOTAL ASSETS14,61024,421 LIABILITIES Share Capital729692Premiums related to share capital534,264533,549Retained earnings(530,828)(508,438)Net loss for the financial year(8,948)(22,390) Total shareholders' equity(4,783)3,413 Provisions for liabilities1,50913Provisions for charges280268 Total provisions for liabilities and charges1,789281 Loans and debts from lending institutions14,81315,064Loans and other financial debts3382Accounts payable and related accounts1,4841,651Tax and social security debts414603Deferred income852735 Total current liabilities17,59618,135 Unrealized exchange gains and valuation differences - Liabilities82,592 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY14,61024,421 Income Statement(in thousands of euros)June 30, 2025June 30, 2024 Sales of services5262Sales of finished products1,0006,067 REVENUE1,5266,069 Reversals of depreciation, amortization, provisions and transfers of expenses-449Other income144105 TOTAL OPERATING INCOME1,6706,623 Other purchases and external charges(5,795)(6,853)Taxes, duties and similar payments(44)(42)Salaries and wages(590)(1,548)Social security expenses(253)(412)Amortization(5)(9)Impairment and provisions(12)-Other expenses(124)(1,247) TOTAL OPERATING EXPENSES(6,823)(10,111) OPERATING PROFIT (LOSS)(5,153)(3,488) Other interest and similar income373398Reversal of provisions, impairment losses and transfer of expenses-13Foreign exchange gains4623 TOTAL FINANCIAL INCOME419434 Amortization, depreciation and financial provisions(2,993)(383)Interest and similar expenses(546)(817)Foreign exchange loss(676)- TOTAL FINANCIAL EXPENSES(4,215)(1,200) FINANCIAL PROFIT (LOSS)(3,796)(766) PRE-TAX LOSS(8,949)(4,254) Exceptional income from previous financial year-3EXCEPTIONAL INCOME-3 Exceptional charges from previous fiscal year-(12)EXCEPTIONAL EXPENSES-(12) EXCEPTIONAL INCOME (LOSS)-(9) Research Tax credit-- NET PROFIT & LOSS(8,949)(4,263) Attachment EN_H12025_PR_FINAL

Financial StatementLicense out/inPhase 3

14 Oct 2025

·www.globenewswire.com

Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations

Additional pre-planned analysis of the NCX 470 Denali trial completed NCX 470 maintains robust intraocular pressure lowering at 6, 9 and 12 months Other analyses broadly in line with the trends seen for Mont Blanc Data presentations planned for upcoming ophthalmology conferences October 2, 2025 – 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. NCX 470 NDA submission in the United States: expected in H1 2026. NCX 470 NDA submission in China: expected shortly after submission in the U.S. NCX 470 Phase 3 clinical program in Japan: Program initiated in summer 2025. Managed and financed by Kowa. 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. 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). The content above comes from the network. if any infringement, please contact us to modify.

Clinical Study

04 Sep 2025

·www.globenewswire.com

Nicox Expects to Fully Repay Financial Debts with NCX 470 De-Risked and Globally Licensed

Press Release Nicox Expects to Fully Repay Financial Debts with NCX 470 De-Risked and Globally Licensed Company expects to fully repay existing financial debts in 2026NCX 470 NDA submissions in U.S. (H1 2026) and subsequently in China Milestones payable on U.S. NDA submission and on approvalGlaukos extends NCX 1728 research agreement Future strategic options under consideration including collaborations or business combinationsQ&A for shareholders available on the Nicox website: Q&A September 4, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it expects to be able to fully repay all existing financial debts in 2026 and provided an update on its portfolio and financial situation. This follows the recent announcements of the licensing of NCX 470 to Kowa, completing our global coverage, and the positive results from our second pivotal Phase 3 clinical trial, Denali. NCX 470 has met the requirements for New Drug Applications (NDA) in the U.S. and China, with NDA submission expected in H1 2026 in the U.S., and subsequently in China. Based on these submissions, the Company expects to have recurrent revenue from 2027, in addition to milestone payments on NDA submission and approval. Costs of the NDA submissions are the responsibility of our partners.“Nicox is a revenue generating biotech with a deep and proven expertise in ophthalmology development, transactions and corporate operations. Following the recent announcement of the licensing deal for NCX 470 with Kowa, which fulfils our global licensing plans, we have also completed the second pivotal Phase 3 clinical trial, Denali, for NCX 470 in the U.S. and China. Our team will be supporting our partners, Kowa and Ocumension, in submitting the NCX 470 New Drug Applications and ensuring broad communication of the product profile and data.” said Gavin Spencer, Chief Executive Officer of Nicox. “We have demonstrated that Nicox can deliver on both the development of major clinical assets and the associated financing, whilst simultaneously implementing commercial solutions. In doing so, we have created long-term revenue streams for the Company, addressed our short-term financial needs and expect to fulfil our obligations to creditors. We believe we are now in a strong position to explore strategic options, including collaborations or business combinations.”Key Future Milestones NCX 470 New Drug Application (NDA) filing in the United States: expected in H1 2026.NCX 470 New Drug Application (NDA) filing in China: expected after submission in the U.S. Results from NCX 470 Phase 3 clinical program in Japan: Program initiated in summer 2025. Managed and financed by Kowa. Financial UpdateNCX 470 is now licensed globally, with milestone payments expected in 2026 and 2027. Royalties on net sales are expected from 2027. Based on the expected upcoming milestones and the repayment of all existing financial debts, the Company is financed into Q3 2026. The Company remains committed to cost control, optimizing resource allocation while maintaining the capabilities required to support our strategic objectives. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company.Portfolio update NCX 470, Nicox’s lead product candidate, is licensed globally to two top-tier pharma partners, Kowa and Ocumension Therapeutics. The first two Phase 3 trials, Mont Blanc and Denali, have met the requirements for submission of NDAs in the U.S. and China. U.S. – based on Nicox’s projections, an NDA with the U.S. Food and Drug Administration (FDA) is expected to be submitted in H1 2026. Kowa is responsible for the costs of the NDA submission.China – an NDA is expected to be filed with the Chinese regulatory authorities by our partner, Ocumension, after the U.S. submission. The costs of filing the NDA are the responsibility of Ocumension.Japan – a Phase 3 confirmatory efficacy and a Phase 3 safety trial have been initiated in Japanese patients. Kowa is responsible for managing the trials, at their cost, and expect to be able to file for a marketing authorisation in Japan based on these trials.Europe – the regulatory strategy is being evaluated. NCX 1728, an NO-donating PDE-5 inhibitor, is being evaluated in a pre-clinical research program exploring indications for the treatment of glaucoma, including neuroprotection, and in the treatment of retinal diseases, under an exclusive research and option to license agreement with Glaukos. Glaukos has paid an extension fee to prolong the period of evaluation of NCX 1728 for the treatment of glaucoma. Evaluation for retinal conditions is also continuing, and is subject to different option conditions.ZERVIATE® (cetirizine ophthalmic solution), 0.24%, is currently commercialized through exclusive licensing agreements in the U.S. by Harrow, Inc. and in China by Ocumension Therapeutics for ocular itching associated with allergic conjunctivitis. VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, is exclusively licensed worldwide to Bausch + Lomb. Nicox sold the royalty revenue from VYZULTA to Soleus Capital in October 2024.NCX 4251: Changes in the U.S. dry eye market suggest that the investment in development may not be justified. NCX 4251 remains available for licensing outside the Chinese market.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.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 Attachment EN_NicoxPipelineAndStrategyUpdateSeptember2025_PR_FINAL

Phase 3License out/inNDA

100 Deals associated with Bimatoprost grenod

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ocular Hypertension	Phase 3	China	Ocumension Suzhou Biotech Co., Ltd.	30 Jan 2022
Glaucoma, Open-Angle	Phase 3	United States	Nicox Ophthalmics, Inc.	01 Jun 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04630808 (Denali, NEWS) Manual	Phase 3	Glaucoma, Open-Angle \| Ocular Hypertension	696	NCX 470 0.1%	ezdyvenmbr(ktcrdvwxpj) = 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. rduhlyiqgw (sujitywlyf ) View more	Non-inferior	21 Aug 2025
				Latanoprost 0.005%
NCT04445519 (MONT BLANC, CTgov)	Phase 3	Glaucoma, Open-Angle	691	NCX 470 0.1% (initial phase of trial) (NCX 470 0.1%)	cswwbndtlg(nrspzdseyg) = wxfnintvuy xwspdtxror (kuqyeyeona, 3.443) View more	-	30 May 2025
				Latanoprost (Latanoprost 0.005%)	cswwbndtlg(nrspzdseyg) = hahijpkvam xwspdtxror (kuqyeyeona, 3.349) View more
NCT05938699 (Whistler, GlobeNewswire) Manual	Phase 3	Ocular Hypertension	18	NCX 470	vknxeieikr(olmifgkrrb) = 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). diebhselrg (eqirckxdvd )	Positive	14 May 2025
				Placebo
NCT04445519 (MONT BLANC, Literature) Manual	Phase 3	Glaucoma, Open-Angle \| Ocular Hypertension	103	NCX 470NCX 470 0.065 %	pbqazrtzpt(mtgzxciget) = 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). ashaszkmff (ddalutmjkc )	Positive	01 Dec 2024
				NCX 470NCX 470 0.1 %
NCT03657797 (Dolomites, CTgov)	Phase 2	Glaucoma, Open-Angle	656	NCX 470 (NCX 470 0.021%)	gnnpasqsdg(dcttyqazip) = xgawaammlv ymzcqzguff (fzacnpxgxk, 2.606) View more	-	08 Dec 2022
				NCX 470 (NCX 470 0.042%)	gnnpasqsdg(dcttyqazip) = ardhowqerr ymzcqzguff (fzacnpxgxk, 2.511) View more
NCT04445519 (Mont Blanc, Corporate Publications) Manual	Phase 3	Glaucoma	691	NCX 470	tobeliklks(opitjjayxg) = npasikyenm ydkwxrxxbq (hlwtgqtotu ) View more	Non-inferior	31 Oct 2022
				Latanoprost	tobeliklks(opitjjayxg) = azsgyubsga ydkwxrxxbq (hlwtgqtotu ) View more
NCT03657797 (Dolomites, AAO2020)	Phase 2	Ocular Hypotension	433	NCX 470 0.021%	vlaaenjnyj(zfnqbztoot) = The most common adverse event was conjunctival hyperemia. There were no treatment-related serious adverse events or treatment-related systemic adverse events hewonjayfu (lnjsuqqnpn )	Positive	13 Nov 2020
				NCX 470 0.065%
NCT03657797 (Dolomites, GlobeNewswire) Manual	Phase 2	Glaucoma	433	NCX-470	xglnuqjrph(otkwwcilvh) = lqkhkglbpj iphlpousmr (alfypfuxco ) View more	Positive	02 Oct 2019
				Latanoprost	xglnuqjrph(otkwwcilvh) = zmzbwwcplv iphlpousmr (alfypfuxco ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Bimatoprost grenod

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation