The primary objective of this study is to determine the effect of latanoprostene bunod (LBN) ophthalmic solution 0.024% (a single dose and 7 days of once daily [QD] dosing) on 2 aspects of aqueous humor (AqH) dynamics (episcleral venous pressure [EVP] and outflow facility) in participants with ocular hypertension (OHT).

Start Date13 May 2022

Sponsor / Collaborator

Bausch & Lomb, Inc.

NCT03931317 / CompletedNot ApplicableIIT

A Randomized, Single Center, Masked, Crossover Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity in Patients With Ocular Hypertension or Primary Open Angle Glaucoma

The purpose of this research study is to compare the effect of Latanoprostene Bunod and Timolol on eye pressure and blood vessels of the back of the eye.

Start Date03 Dec 2018

Sponsor / Collaborator

University of California San Diego

[+1]

NCT01895972 / CompletedPhase 3

A Single-Arm, Multicenter, Open-Label Study Evaluating the Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024%, in Japanese Subjects With Open-Angle Glaucoma or Ocular Hypertension

The objective of this study is to demonstrate the clinical safety of latanoprostene bunod 0.024% once daily (QD) over a 1-year treatment period.

Start Date05 Jul 2013

Sponsor / Collaborator

Bausch & Lomb, Inc.

100 Clinical Results associated with Latanoprostene Bunod

100 Translational Medicine associated with Latanoprostene Bunod

100 Patents (Medical) associated with Latanoprostene Bunod

Literatures (Medical) associated with Latanoprostene Bunod

01 Feb 2024·Current opinion in pharmacology

Currently available prostanoids for the treatment of glaucoma and ocular hypertension: A review

Review

Author: Anter, Abdelrahman M ; Bhattacharya, Sanjoy K ; Arcuri, Jennifer ; Benitez, Betsy

Recent advancements in prostaglandin analogs (PGAs) have reinforced their role in managing intraocular pressure (IOP). Latanoprost excels in 24-h IOP control, while various PGAs offer similar effectiveness and side effects, generic PGAs perform as well as branded ones, and a notable IOP rise observed upon PGA discontinuation. Formulations with or without preservatives show comparable IOP reduction and adherence, often surpassing benzalkonium chloride (BAK)-preserved options. Emergent PGAs, such as latanoprostene bunod, fixed-dose netarsudil combined with latanoprost, and omidenepag Isopropyl, offer enhanced or non-inferior IOP reduction. The bimatoprost implant introduces a novel administration method with effective IOP reduction. These developments underscore ongoing progress in PGA-focused ophthalmological research. This article offers a comprehensive review of available prostanoid analogs and explores new developments.

17 Jan 2024·Journal of current glaucoma practice

Ocular Surface Evaluation after Switch from Latanoprost 0.005% to Latanoprostene Bunod 0.024%

Article

Author: Zanutigh, Virginia ; Valvecchia, Florencia ; Logioco, Celina ; Galetto, Leila

Aim and background:

To evaluate the ocular surface of patients treated with latanoprost (LT) 0.005% who switched to latanoprostene bunod (LBN) 0.024%.

Materials and methods:

A prospective and nonrandomized clinical study of a case series was performed, including patients with chronic open-angle glaucoma who were on previous LT-only treatment and, after a washout period, switched to LBN, with a 3-month follow-up. The main parameter to be evaluated was the ocular surface disease index (OSDI) test. In addition, best-corrected visual acuity (BCVA), intraocular pressure (IOP), biomicroscopic aspect of the ocular surface, measuring tear breakup time, fluorescein staining (grading performed on Oxford scale) and Schirmer I test were evaluated.

Results:

A total of 36 patients (72 eyes) were included, 21 women (58.3%) and 15 men (41.7%, with a mean age of 65.6 ± 10.9 years (37-86). The initial OSDI score was 17.8 ± 12.1 and improved to 11.1 ± 10.5 (p < 0.01). From the data evaluated at biomicroscopy, an improvement was observed in the Oxford scale from 0.6 ± 0.7 to 0.2 ± 0.8 (p: 0.01), but no statistically significant changes were observed in the break-up time (BUT) and Schirmer. BCVA remained stable, as did IOP, which was initially 13.4 ± 2.1 mm Hg and, after performing the LBN treatment change, went to 13.1 ± 1.7 mm Hg.

Conclusion:

After the change of treatment from LT 0.005% to LBN 0.024%, the patients had an improvement in the ocular surface, maintaining control of their IOP. The need to investigate possible beneficial mechanisms on the ocular surface in glaucoma patients treated with LBN, potentially related to nitric oxide, is raised.

Clinical significance:

Patients treated with LT 0.005% who switched to LBN 0.024% had an improvement in ocular surface symptoms and signs, keeping IOP under control.Latanoprostene bunod (LBN) 0.024% may have beneficial effects on the ocular surface, which should be further studied.

How to cite this article:

Zanutigh V, Galetto L, Valvecchia F, et al. Ocular Surface Evaluation after Switch from Latanoprost 0.005% to Latanoprostene Bunod 0.024%. J Curr Glaucoma Pract 2023;17(4):205-209.

01 Jan 2024·Journal of cataract and refractive surgery

Difficult decisions, filtration surgery, and the heartbreak of the numerator

Article

Author: Gedde, Steven J ; Zhang, Amy D. ; Grover, Davinder S ; Brubaker, Jacob W. ; Paranjpe, Vikram R. ; Fellman, Ronald L. ; Singh, Kuldev ; Paranjpe, Vikram R ; Barton, Keith ; Ahmed, Iqbal Ike K ; De Francesco, Ticiana ; Samuelson, Thomas W. ; Gedde, Steven J. ; Brubaker, Jacob W ; Grover, Davinder S. ; Zhang, Amy D ; Fellman, Ronald L ; Ahmed, Iqbal Ike K.

A 70-year-old man had progressive and severe glaucoma in each eye. He was intolerant to dorzolamide, brimonidine, and netarsudil. Each eye had prior selective laser trabeculoplasty (SLT) as well as phacoemulsification plus minimally invasive glaucoma surgery (MIGS) 6 years before current presentation (iStent [Glaukos Corp.] in the right eye and Cypass [Alcon Laboratories, Inc.] in the left eye). Postoperative acuities were 20/20 and 20/25 in the right and left eyes, respectively.When his left eye progressed with loss of central acuity despite peak intraocular pressures (IOPs) in the middle to upper teens, neuro-ophthalmology consultation was obtained (Figure 1 JOURNAL/jcrs/04.03/02158034-202401000-00017/figure1/v/2023-12-22T124801Z/r/image-tiff ). That workup included magnetic resonance imaging scan and hematologic screening, but all results were negative, and the neuro-ophthalmic consultant concluded that the vision loss was likely on the basis of glaucoma. Accordingly, a trabeculectomy was performed in the left eye achieving consistent IOPs in the range of 7 to 10 mm Hg without medications, rending the left eye stable since the filtration surgery nearly 2 years previously.The right eye continued to progress both subjectively and objectively, and on recent examination, the IOP measured 20 mm Hg and 09 mm Hg in the right and left eyes, respectively (Figure 2 JOURNAL/jcrs/04.03/02158034-202401000-00017/figure2/v/2023-12-22T124801Z/r/image-tiff ). Medications included timolol and latanoprostene bunod in the right eye only. Central corneal thickness was 526 μm and 527 μm in the right and left eyes, respectively. The visual acuity now measured 20/25 in the right eye and 20/250 in the left eye. The vertical cup-to-disc ratio was 0.9 in the right eye and 1.0 in the left eye. Gonioscopy revealed a wide open angle in each eye with a patent sclerostomy superiorly in the left eye. The conjunctiva and sclera were healthy and without scarring in the right eye. The bleb in the left eye was diffuse, lightly vascularized, and seidel negative. Axial length (AL) was 26.88 μm in the right eye and 26.77 μm in the left eye. The patient was in good health and was not anticoagulated.An extensive discussion ensued about the best course of action for the right eye.How would you proceed in managing definite progression in this individual's right eye, knowing that he had lost fixation in his left eye at similar pressures?

News (Medical) associated with Latanoprostene Bunod

02 Dec 2024

·www.globenewswire.com

Nicox’s Denali Phase 3 Trial of NCX 470 Fully Enrolled in China Earlier than Expected

Press ReleaseNicox’s Denali Phase 3 Trial of NCX 470 Fully Enrolled in China Earlier than Expected Confirms topline results expected to be reported Q3 2025 NCX 470 demonstrated robust efficacy and safety in topline results from first Phase 3 trial, Mont BlancNCX 470 partnering efforts will focus on routes for bringing the product to market in the U.S.Results from the NCX 470 Phase 3b Whistler Mechanism of Action trial expected in Q1 2025 December 2, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension, is now fully enrolled in China and screening has been closed. Completion of recruitment of patients in the U.S. for the trial was announced in July 2024 and therefore the target number of patients to be enrolled in the Denali trial has been met. Topline results are expected in Q3 2025.“Following completion of the recruitment of the Denali trial in the United States, we have seen an acceleration in the number of Chinese patients randomized in this multi-center international trial, allowing us to close Chinese patient recruitment earlier than expected.” said Doug Hubatsch, Chief Scientific Officer of Nicox. “I would like to thank the teams at both Nicox and Ocumension and the clinical staff and patients at our sites, as well as our partner organisations for their dedication through the final stages of the recruitment. We look forward to announcing the topline results in Q3 next year. Whilst we continue the final stages of this trial, we are also completing the additional development steps necessary to support the preparation of New Drug Applications in both the United States and China to ensure that these could be submitted as soon as possible after the receipt of the Denali topline data.” “NCX 470 continues to generate interest from potential commercialisation partners. With strong collaborations in Japan, China, Korea and Southeast Asia already in place, we are focussing on the route to commercialisation for NCX 470 in the United States, with potential for regional partnerships elsewhere.” added Emmet Purtill, VP Business Development. The Denali trial is evaluating the intraocular pressure (IOP) lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the Mont Blanc trial, was designed to fulfill the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. The company estimates that a U.S. NDA for NCX 470 could potentially be submitted in H1 2026, subject to the company entering into a partnership for the commercialization of NCX 470 in the U.S. or obtaining appropriate financing.Topline results from the first Phase 3 trial, Mont Blanc, showed the IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost. Statistical non-inferiority was met vs. latanoprost in the primary efficacy analysis and 4 out of 6 timepoints additionally demonstrated superiority; the trial therefore met the efficacy requirements for approval in the U.S. NCX 470 was well tolerated and discontinuation rates were low. The results of the Mont Blanc trial have been published in the prestigious American Journal of Ophthalmology, and numerous post hoc analyses have been presented. Full details of all presentations and publications can be found at nicox.com/pipeline-markets-and-science/#publications.About NCX 470NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that leverages the potent IOP lowering effects of NO and prostaglandin analogs (PGAs). NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule. NCX 470 is designed to release bimatoprost and NO into the eye to lower IOP by two different pathways in patients with open-angle glaucoma or ocular hypertension. NO is a well-known small, naturally occurring signaling molecule that plays a key role in the regulation of IOP through activation of soluble guanylate cyclase. NO brings additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action to that of PGAs. Bimatoprost, marketed under the brand name LUMIGAN® by AbbVie, Inc., is the leading branded PGA. PGAs are the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension.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 2023” and in section 4 of the “Rapport semestriel financier et d’activité 2024” 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_DenaliLastPatient_PR_20241202_FINAL

Phase 3Clinical ResultLicense out/in

19 Nov 2024

·www.globenewswire.com

Nicox Announces Publication of the Adaptive Design Period of the NCX 470 Mont Blanc Phase 3 Trial

Press Release Nicox Announces Publication of the Adaptive Design Period of the NCX 470 Mont Blanc Phase 3 Trial An adaptive design is a useful clinical trial design tool which allowed identification of the optimal dose of NCX 470 in the Mont Blanc trial, the first Phase 3 trial of NCX 470Both doses of NCX 470 ophthalmic solution tested, 0.065% and 0.1%, lowered intraocular pressure more than the comparator, latanoprost 0.005% ophthalmic solutionThe 0.1% NCX 470 concentration was chosen for the remainder of the Mont Blanc trial and the ongoing Denali trial based on a greater intraocular pressure reduction compared to the 0.065% concentration and a good safety profile November 18, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the design details and results of the adaptive design period of the NCX 470 Mont Blanc Phase 3 trial evaluating the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension have been published online in Contemporary Clinical Trials, Volume 147, 2024, 107730 (online pre-publication https://doi.org/10.1016/j.cct.2024.107730). A portion of this data has previously been presented as a poster at the 2023 World Glaucoma Congress. The dose finding Phase 2 trial (Dolomites) tested NCX 470 at several concentrations and the results suggested that a higher dose than those tested might provide even better efficacy and safety profile. To test this, concentrations of 0.065% and 0.1% were included in an adaptive dose selection period of the Phase 3 Mont Blanc trial, which compared the safety and efficacy of NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution in adult subjects with open-angle glaucoma or ocular hypertension. At the Week 2 timepoint, the least-squares mean difference in diurnal intraocular pressure (IOP) compared to latanoprost were 1.51 mmHg for NCX 470 0.065 % group (p = 0.0308) and 1.71 mmHg for NCX 470 0.1 % group (p = 0.0123), in favor of NCX 470. 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).The adaptive dose selection period was used in place of additional dose ranging studies to select the 0.1% concentration of NCX 470 for the completion of the Mont Blanc clinical trial as well as the second Phase 3 trial, Denali.The results of the Mont Blanc trial were announced in October 2022. The second Phase 3 trial of NCX 470, Denali, is ongoing and topline results are expected in the third quarter of 2025.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.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 2023” and in section 4 of the “Rapport semestriel financier et d’activité 2024” 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_MontBlancAdaptiveDesignPublication_PR_FINAL

Phase 3Clinical ResultPhase 2

17 Oct 2024

·www.globenewswire.com

Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results

Press Release Nicox Provides Third Quarter 2024 update and First Half 2024 Financial Results Topline results from the NCX 470 (bimatoprost grenod) Phase 3 Denali clinical trial expected in Q3 2025Cash of €19.7 million on September 30, 2024, including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024The Company estimates that it is financed into Q3 2025 October 17, 2024 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the revenue and cash position for Nicox SA and its subsidiaries (the “Nicox Group”) for the third quarter of 2024 and financial results for Nicox SA (the “Company”) for the first half of 2024, as approved by the Board of Directors on October 16, 2024 and provided an update on key future milestones. As previously announced, the Company is no longer reporting consolidated accounts under IFRS standards and figures communicated for the Nicox Group are for information only. “The first 9 months of 2024 have been a period of significant strategic progress for Nicox, in which we have stabilized our financial situation with a royalty sale, optimised our cost structure to focus on our lead asset and partnerships, renewed the Board of Directors and increased our institutional shareholder base through targeted financing activities. Our development team has also continued driving the NCX 470 Denali clinical trial with the completion of recruitment in the United States in July, and the target date for topline results now advanced to Q3 2025.” said Gavin Spencer, Chief Executive Officer of Nicox. “We have also seen major progress in our partnership activity, with our Chinese licensee Ocumension Therapeutics obtaining approval for ZERVIATE in China, where we are now awaiting the commercial launch, and the signature of a new research agreement, including a pre-agreed license option, for NCX 1728 with leading ophthalmic pharmaceutical and medical technology company Glaukos. Going forward we will be focussing on the completion of the Denali trial and partnerships for the commercialisation of NCX 470 in the United States and elsewhere.” Key Future Milestones Launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: Approval obtained in September 2024. Whistler Phase 3b clinical trial, initiated in December 2023, investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: results are currently expected in the first quarter of 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: recruitment of the last patient in the U.S. in the Denali trial was in July when overall recruitment was approaching the 95% level, with recruitment continuing in China and topline results are expected in Q3 2025. Management ChangeEmmet Purtill, Vice President of Business Development at Nicox, has joined the Executive Committee. Emmet has been with the company since 2006 and has played a significant role in establishing our partnerships, notably the relationships with Ocumension and Kowa, and had led many of our recent deals. Emmet joins Sandrine Gestin, VP Finance and HR, Doug Hubatsch, Chief Scientific Officer and Gavin Spencer, Chief Executive Officer, who are the other Executive Committee members.Revenue, Cash Position for the Nicox Group for the Third Quarter 2024 and post-period events Due to the sale of the VYZULTA royalty, the Nicox Group received no material revenue in the third quarter of 2024 compared to €1.8 million (net revenue1 €1.1 million, entirely composed of net royalties) for the first quarter 2023.$16.5 million Royalty and Equity Financing with Soleus announced on October 14, 2024.Cash of €19.7 million at 30 September 2024 including the estimated net proceeds from the VYZULTA royalty sale and accompanying investment mentioned above, after deduction of legal, banking and other fees, compared to €7.7 million at 30 June 2024. Based on this cash position, expected milestone income from existing agreements, and accounting for the €5.2 million debt repayments by June 2025, the Company estimates that it is financed into Q3 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. The Company cannot guarantee that it is financed to the topline results of the Denali trial, and completion of the Denali clinical trial may require additional financing.As of September 30, 2024, the Nicox Group had financial debt of €20.4 million (entirely held by Nicox SA), consisting of €19.4 million in the form of a bond financing agreement with Kreos Capital (an affiliate of BlackRock), and a €1.0 million credit agreement guaranteed by the French State, and granted in the context of the COVID-19 pandemic. Nicox will be repaying €5.2 million of the Kreos Capital debt by June 2025.The Company continues to evaluate all options for non-dilutive and dilutive financing to extend its cash runway. In particular the Company is actively exploring multiple strategic options which could facilitate the development and commercialization of its product candidate NCX 470 and the future growth of the Company. First Half 2024 Financial Results for Nicox SA Net revenue1 for the first half of 2024 was €4.9 million (including €1.7 million of net royalty payments and a license payment of €3.0 million) versus €1.7 million (consisting entirely of net royalty payments) for the first half of 2023. Operating expenses for the first half of 2024 were €10.1 million compared to €14.8 million for the first half of 2023. The decrease in operating expenses for the first half of 2024 compared with the first half of 2023 is explained by the costs related to the finalization of the Mont-Blanc study which had an impact on the first half of 2023. In addition, operating expenses for the first half of 2023 included a €3.5 million adjustment relating to the rebilling of services performed in 2022 by the U.S. subsidiary.Net loss for the six months ended June 30, 2024, was €4.4 million, compared to a net loss of €12.5 million for the same period in 2023. The reduction in the net loss for the first half of 2024 is mainly due to the increase in revenues following the signature of the agreement with Kowa for Japan for which the Company has received an initial payment of €3 million, and to the reduction in operating expenses as explained above.As of June 30, 2024, Nicox SA had cash and cash equivalents of €7.7 million as compared with €11.3 million as of December 31, 2023. Including the estimated net proceeds of the VYZULTA royalty sale and equity investment announced on October 14, 2024 and exclusively on the basis of the development of NCX 470, the Company estimates it is currently funded into Q3 2025. As of June 30, 2024, Nicox SA had financial debt of €20.5 million, consisting of (i) €19.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and (ii) a €1.1 million credit agreement guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.Only the figure related to the cash position and the debt of Nicox SA as of December 31, 2023, 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 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 2023” 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) June 30, 2024June 30, 2023Sales of services – Various re-invoicing 23Royalties for patent grants 6 0672 721REVENUE 6 0692 724Reversals of depreciation, amortization, provisions and transfers of expenses 4497Other income 10577TOTAL OPERATING INCOME 6 6232 807Other purchases and external charges (6 853)(12 049)Taxes, duties and similar payments (42)(63)Salaries and wages (1 548)(918)Social security expenses (412)(361)Amortization (9)(11)Provisions for liability and charges -(108)Other expenses (1 190)(1 189)Exchange loss on receivables and debts (57)(130)TOTAL OPERATING EXPENSES (10 111)(14 829) OPERATING PROFIT (LOSS) (3 488)(12 022)Other interest and similar income 398550Reversal of provisions, impairment losses and transfer of expenses 1339Foreign exchange gains 23110TOTAL FINANCIAL INCOME 434699Amortization, depreciation and financial provisions (311)(306)Interest and similar expenses (789)(790)Foreign exchange loss -(212)Interests on loan (28)(29)Net expense from sales of investments securities (72)(185)TOTAL FINANCIAL EXPENSES (1 200)(1 522) FINANCIAL PROFIT (LOSS) (766)(823) PRE-TAX LOSS (4 254)(12 845)Exceptional income on management operations 3-Exceptional income from previous financial year -63EXCEPTIONAL INCOME 363 EXCEPTIONAL INCOME (LOSS) (23)63Research tax credit -251NET PROFIT & LOSS (4 277)(12 531) Balance sheet June 30, 2024December 31, 2023(in thousands of euros) ASSETS Intangible fixed assets1824Tangible fixed assets1426Financial fixed assets1 7291 805 FIXED ASSETS1 7611 855 Trade receivables and related accounts3 0223 424Other receivables (1)34 98434 324Cash assets7 65411 259Prepaid expenses1 207886 CURRENT ASSETS46 86749 893 Unrealized foreign exchange losses and valuation differences – Assets713Loan redemption premiums9141 218 TOTAL REGULARISATION ACCOUNTS9211 231 TOTAL ASSETS49 54952 979 LIABILITIES Share Capital63550 170Premiums related to share capital532 068529 478Retained earnings(508 438)(537 354)Net loss for the financial year(4 277)(20 881) Total shareholders' equity19 98821 413 Provisions for liabilities713Provisions for charges256700 Total provisions for liabilities and charges263713 Loans and debts from lending institutions20 53620 895Loans and other financial debts3 1564 258Accounts payable and related accounts1 5802 498Tax and social security debts515648Deferred income1 9951 919 Total current liabilities27 78230 218 Unrealized exchange gains1 516635 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY49 54952 979 1 Net revenue consists of revenue from collaborations less royalty payments Attachment EN_H1&Q32024_PR_FINAL

License out/inPhase 3Financial Statement

100 Deals associated with Latanoprostene Bunod

External Link

KEGG	Wiki	ATC	Drug Bank
D10441	Latanoprostene Bunod	S01EE06	DB11660

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Glaucoma	CA	Bausch & Lomb, Inc.	17 May 2019
Glaucoma, Open-Angle	US	Bausch & Lomb, Inc.	02 Nov 2017
Ocular Hypertension	US	Bausch & Lomb, Inc.	02 Nov 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glaucoma 1, Open Angle, A	Phase 2	US	Bausch & Lomb, Inc.	01 Mar 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03931317 (Pubmed \| Am J Ophthalmol) Manual	Not Applicable	Glaucoma, Open-Angle \| Ocular Hypertension	50	Latanoprostene Bunod	nwsojfutqq(jdxcxzxsfd) = obactsunlm fflrteknid (lkvespvwdw )	Positive	05 May 2022
				Timolol	-
ARVO2022	Not Applicable	Glaucoma, Open-Angle	65	Vyzulta	bfjcqkqfet(hbiixmdkng) = arwugaxkdp sqnwbldqmj (pidocntgbk )	-	01 May 2022
				Latanoprost	bfjcqkqfet(hbiixmdkng) = nnrnrfcieg sqnwbldqmj (pidocntgbk )
ARVO2022	Not Applicable	-	-	Latanoprostene bunod ophthalmic solution	tuodavuhpf(ukkicsvcmc) = Both latanoprostene bunod and latanoprost administration resulted in mild to moderate conjunctival hyperemia zhvidfccmi (wxeesgdqoq )	Positive	01 May 2022
ARVO Annual Meeting (ARVO2021)	Not Applicable	Glaucoma	36	Latanoprostene bunod	grmjpjeqnh(ucwmrmhycn) = rwhnwutkyx usbbuxnbjo (uqjjjonfxq ) View more	Positive	01 Jun 2021
AAO2020	Not Applicable	-	80	Latanoprostene Bunod	ekynsdotcm(iplenmeqvx) = Four patients discontinued for adverse effects mudwamzvyj (ojqbthfray )	-	13 Nov 2020
NCT00595101 (CTgov)	Phase 2	Glaucoma, Open-Angle	117	PF-0318 (PF-0318 0.006%)	rpiaeewdsa(ohujqnnzda) = themzaccby sowxfqdqka (uuzuilscem, qmleqlawdt - ebhylqardw) View more	-	27 Aug 2020
				PF-0318 (PF-0318 0.024%)	rpiaeewdsa(ohujqnnzda) = kulzomtefo sowxfqdqka (uuzuilscem, llfhyppqds - ginxbndhtl) View more
NCT00441883 (CTgov)	Phase 2	Glaucoma 1, Open Angle, A	176	PF-03187207 (PF-03187207 0.024% AM)	bqaxnjujsh(nzlugsscnw) = ilwdxmbuor ygcewawwtz (sykvkzrcvz, rjchcqkkeh - kqiguxcepy) View more	-	27 Aug 2020
				PF-03187207 (PF-03187207 0.040% AM)	bqaxnjujsh(nzlugsscnw) = chfigfhnyy ygcewawwtz (sykvkzrcvz, frvnwgxnjs - dwktgbvsxl) View more
2020 ARVO Annual Meeting (ARVO2020)	Not Applicable	Glaucoma	-	Netarsudil 0.02%	hudimgytyg(ruxaeejjaq) = wlsugjgcwh igmtwbsocj (sogubztuyq ) View more	Positive	01 Jun 2020
				Latanoprostene Bunod 0.024%	hudimgytyg(ruxaeejjaq) = ocljdowurk igmtwbsocj (sogubztuyq )
ARVO2020	Not Applicable	Ocular Hypertension \| Glaucoma	65	Latanoprostene bunod 0.024%	yjlewilqdq(qbrvnxxqgc) = one patient reported ocular redness in one eye (0.8%) bgvptlffro (gkjzhljdxt )	-	01 Jun 2020
2019 ARVO Annual Meeting (ARVO2019)	Not Applicable	Glaucoma, Open-Angle	11	Latanoprostene bunod	asibqewafl(hnguogetsh) = maxsnjsihs lbqtzyprob (pnxtkkqpuw, ± 447)	Positive	01 Jul 2019

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