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.

NCT03949244

/ CompletedPhase 4IIT

Effect of Nailfold Application of Latanoprostene Bunod on Nailfold Capillary Blood Flow

The purpose of this study is to look at the relationship of small blood vessels irregularities observed with an imaging system called video nailfold capillaroscopy in people with primary open-angle glaucoma. Nailfold capillaroscopy (NFC) is a video camera with a magnifying lens used for studying the movement of blood in small blood vessels. It is simple, safe and does not penetrate the skin. The skin fold that is at the tip of the finger is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.

Start Date15 Aug 2019

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

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]

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 Sep 2025·Medical Gas Research

Corrigendum: Latanoprostene bunod: the first nitric oxide-donating antiglaucoma medication

Article

01 Jun 2025·Ophthalmology and Therapy

Latanoprostene Bunod 0.024% Early Experience Program (LEEP): A Canadian Initiative for Open-Angle Glaucoma and Ocular Hypertension

Article

Author: Harasymowycz, Paul ; Hutnik, Cindy M L ; Yan, David

INTRODUCTION:

Here we report the intraocular pressure (IOP) changes following treatment with latanoprostene bunod (LBN) 0.024% in patients in Canadian ophthalmology practices.

METHODS:

This real-world, open-label, 6-week, observational study collected data from 59 Canadian ophthalmologists and a total of 653 patients. Eligibility was open to all patients treated with LBN 0.024% instilled once daily for open-angle glaucoma or ocular hypertension. IOP was assessed prior to initiating LBN and after a planned 6 weeks of treatment. Patient demographics, prior treatment(s), IOP, and patient/physician satisfaction ratings were recorded. Subgroup analyses included (1) patients naïve to prior IOP-lowering medication (with or without prior selective laser trabeculoplasty [SLT]) initiating LBN; (2) patients switching from a pre-existing medication to LBN; and (3) patients adding LBN to existing medications.

RESULTS:

Of 653 patients included, 251 were naïve to previous medical antihypertensive therapy, 369 were switched to LBN from a previous medication, and 26 added LBN on top of existing medications (seven patients did not indicate status). Mean baseline IOP was 19.5 mmHg in the overall cohort and follow-up occurred over a period of 37.9 ± 7.9 days. Mean IOP was reduced by 16.3% (95% confidence interval 14.9-17.7) across all included patients. Overall IOP reduction from baseline was largest for naïve patients with no prior SLT (29.3%), with age and baseline IOP key determinants of outcomes in this group. Patient and physician satisfaction scores were high.

CONCLUSION:

This initial Canadian clinical experience of LBN in diverse patient and physician populations reflected its use in a real-world context, and demonstrated a significant IOP-lowering effect with LBN across patient groups seen in routine practice. Patient and physician satisfaction scores were high and in notable agreement.

01 Jun 2025·Medical Gas Research

Latanoprostene bunod: the first nitric oxide-donating antiglaucoma medication

Review

Author: Shalaby, Wesam Shamseldin ; Razeghinejad, Reza ; Soltani, Ghazaleh

Glaucoma is a chronic optic neuropathy that causes characteristic visual field defects and is considered one of the leading causes of irreversible vision loss worldwide. Lowering intraocular pressure is the only proven treatment for glaucoma. Medical therapy is usually the first-line treatment for open-angle glaucoma and ocular hypertension. Latanoprostene bunod ophthalmic drop 0.024% is a nitric oxide-donating prostaglandin F2α analog. It lowers the intraocular pressure via a dual mechanism of enhancing aqueous humor outflow through both the trabecular meshwork and uveoscleral pathways. Additionally, the nitric oxide component has shown promise in regulating ocular blood flow and promoting the survival of retinal ganglionic cells. Herein, the mechanism of action, efficacy, safety, and tolerability of the latanoprostene bunod and its effects on ocular blood flow are reviewed. Latanoprostene bunod has demonstrated strong efficacy and a favorable safety profile in both clinical trials and real-world studies. Given the promising results of latanoprostene bunod and advancements in drug delivery, topical fixed-combination and sustained-release formulations containing latanoprostene bunod and other agents targeting different intraocular pressure-lowering mechanisms may become available in the future.

100

News (Medical) associated with Latanoprostene Bunod

27 May 2025

·www.einpresswire.com

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

Press Release Nicox Announces up to €3 million in Milestone Payments from Kowa in 2025 as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan Exclusive Japanese partner Kowa has received regulatory approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan Milestone payments from Kowa totaling €3 million expected to be received by Nicox in 2025 Extends Nicox’s cash runway until the end of 2025 May 27, 2025 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Japanese partner for NCX 470, Kowa, has received Clinical Trial Notification (equivalent of a U.S. Investigational New Drug, IND) approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan, triggering a €1 million milestone payment to Nicox. The clinical trials are expected to be initiated in H2 2025, which would trigger a second milestone payment of €2 million. “ This important achievement, which enables the initiation of phase 3 clinical development of NCX 470 for Japanese patients, demonstrates the effective collaboration established between the Kowa and Nicox teams and represents a significant advance by Kowa in the delivery of their accelerated development plan. As a result, we expect to receive a total of €3 million in development milestones from Kowa in 2025, extending our cash runway until at least the end of 2025 . ” said Gavin Spencer, Chief Executive Officer of Nicox. “ We congratulate our Japanese partner on the swift progress and look forward to continuing to work with them to bring NCX 470 to the Japanese market. ” Cash Runway Based on the current cash position, estimated revenue and anticipated milestone payments (including the Kowa milestones mentioned above) Nicox now estimates that it is financed until the end of 2025. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. Key Future Milestones Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025 NCX 470 Phase 3 clinical trial in Japan: Initiation expected in H2 2025 Kowa NCX 470 License Nicox licensed the rights to develop and commercialize NCX 470 in Japan to Kowa in February 2024. Nicox may receive a further €7 million in development and regulatory milestones, up to €17.5 million in sales milestones and tiered royalties from 7% to 12% on net sales of NCX 470 in Japan. Kowa is responsible for all development, regulatory and commercialization costs for NCX 470 in Japan. About NCX 470 NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in Q3 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.com Analyst coverage H.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts Nicox Gavin Spencer Chief Executive Officer T +33 (0)4 97 24 53 00 communications@nicox.com Disclaimer The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “ Rapport Annuel 2024 ” which is available on Nicox’s website (www.nicox.com). Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox S.A. Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France T +33 (0)4 97 24 53 00 Attachment EN_NCX470JapanINDApprovalMay2025_PR_FINAL Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3

14 May 2025

·www.globenewswire.com

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

Press Release Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial Several aqueous humor parameters stimulated by nitric oxide were statistically significant or trended in favor of NCX 470; likewise those that respond to prostaglandin analogsEpiscleral venous pressure changes did not show a trend vs. placeboSafety profile is consistent with that of the first Phase 3 trial, Mont BlancNCX 470 intraocular pressure lowering efficacy and safety have already been demonstrated in the Phase 3 glaucoma trial, Mont BlancTimeline and planning for New Drug Application submissions remain on track May 14, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the results of the Whistler Phase 3b exploratory clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering in healthy volunteers and ocular hypertensive patients.“We believe that the outcomes in favor of NCX 470 in several trabecular meshwork aqueous humour dynamics parameters are due to nitric oxide. These positive exploratory results suggest that further investigation may be warranted into the dual mechanism effect of NCX 470 on intraocular pressure.” said Doug Hubatsch, Chief Scientific Officer of Nicox. “The therapeutic characteristics of NCX 470 demonstrated in the Phase 3 program so far shows that we have an approvable and differentiated asset with a promising clinical profile. We look forward to announcing the safety and efficacy results from our ongoing Phase 3 trial, Denali, expected in the third quarter of this year.” The Whistler Phase 3b exploratory trial was a double-masked, placebo-controlled study designed to further our understanding of the action of NCX 470 ophthalmic solution, 0.1%, on various aqueous humor dynamic parameters in 18 healthy volunteers or subjects with ocular hypertension. Measurements were taken at baseline and after 8 days at 1 pm and, for some parameters, at 3 pm. Changes in aqueous humor flow rate trended towards significance vs. placebo (p=0.072). Outflow facility was positive at 1 pm (p=0.081), significant at 3 pm (p=0.001), as was the diurnal outflow (p=0.004). We believe this change is due to the effect of nitric oxide on the trabecular meshwork1. IOP lowering and uveoscleral outflow were statistically significant at all timepoints measured, whilst episcleral venous pressure did not show a notable trend. These findings support the dual mechanism of action for IOP lowering of NCX 470 through both the conventional (nitric oxide-stimulated) and the uveoscleral (prostaglandin-stimulated) pathways. The safety profile observed was consistent with that of the first Phase 3 trial, Mont Blanc. The Whistler trial was an exploratory trial and is not a requirement for the submission of New Drug Applications for NCX 470 and therefore does not impact the development timeline. The patient population in the Whistler trial was primarily normotensive healthy volunteers with mean baseline IOPs of 16.6 mmHg and 16.9 mmHg for NCX 470 and placebo treated patients, respectively. This is not the same patient profile as in the Phase 3 glaucoma program. Safety and efficacy have already been demonstrated in the first Phase 3 clinical trial, Mont Blanc. The results of the Mont Blanc trial are available on the Company’s website, www.nicox.com. About NCX 470NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in Q3 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” which is available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 For examples of the role of nitric oxide on these parameters, see Dismuke WM, Liang J, Overby DR, Stamer WD. Concentration-related effects of nitric oxide and endothelin-1 on human trabecular meshwork cell contractility. Exp Eye Res. 2014;120:28–35 and Wiederholt M, Sturm A, Lepple-Wienhues A. Relaxation of trabecular meshwork and ciliary muscle by release of nitric oxide. Invest Ophthalmol Vis Sci. 1994;35:2515–2520. Attachment EN_WhistlerResultsMay2025_PR_FINAL

Phase 3Clinical Result

30 Apr 2025

·www.pharmaindustrial-india.com

Gland Pharma Secures USFDA Approval for Latanoprostene Bunod Ophthalmic Solution

Gland Pharma Ltd., a generic injectable and ophthalmic-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Latanoprostene Bunod Ophthalmic Solution, 0.024 percent. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024 percent, of Bausch and Lomb, Inc. This Product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Gland Pharma is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity. According to IQVIA, the product had US sales of approximately USD 171 million for the twelve months ending February 2025.

Drug Approval

100 Deals associated with Latanoprostene Bunod

External Link

KEGG	Wiki	ATC	Drug Bank
D10441	Latanoprostene Bunod	S01EE06	DB11660

R&D Status

10 top approved records.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

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	hbvodyrsrz(bvhvvlbwqd) = fgqxeucwvd oqxkzcpwev (oftbgdyjcc )	Positive	05 May 2022
				Timolol	-
ARVO2022	Not Applicable	Glaucoma, Open-Angle	65	Vyzulta	laafdxzmij(vxcszwwoud) = hdgfkdyark keptwefshe (eojfnyfenx )	-	01 May 2022
				Latanoprost	laafdxzmij(vxcszwwoud) = anuepaecfj keptwefshe (eojfnyfenx )
ARVO2022	Not Applicable	-	-	Latanoprostene bunod ophthalmic solution	izygbrolfw(mmduzxnpla) = Both latanoprostene bunod and latanoprost administration resulted in mild to moderate conjunctival hyperemia dvuuvvftta (oyvvrwmpng )	Positive	01 May 2022
NCT03949244 (CTgov)	Phase 4	Glaucoma, Open-Angle	47	Nailfold capillaroscopy+Latanoprost 0.005% (Latanoprost 0.005%)	nomsalvgbk(fsphrshxwh) = ckkjlrbeii ctsptyipvl (oqpbzjbexx, 37.76) View more	-	23 Aug 2021
				Nailfold capillaroscopy+Latanoprost bunod 0.024% (Latanoprost Bunod 0.024%)	nomsalvgbk(fsphrshxwh) = fjjciiupvg ctsptyipvl (oqpbzjbexx, 78.31) View more
ARVO Annual Meeting (ARVO2021)	Not Applicable	Glaucoma	36	Latanoprostene bunod	eodwzpvatt(oxlekjuxqf) = gftffvavdm ezgnrlibyq (qktceqsgic ) View more	Positive	01 Jun 2021
AAO2020	Not Applicable	-	80	Latanoprostene Bunod	pkhlwuxcuc(egpxshdunj) = Four patients discontinued for adverse effects equlgqfpnn (lkirkupfwx )	-	13 Nov 2020
NCT00595101 (CTgov)	Phase 2	Glaucoma, Open-Angle	117	PF-0318 (PF-0318 0.006%)	sojyuolvlu(ngdgqrquyg) = bkbczoejdn ggazfpfeft (sgyanvsvzb, 2.55) View more	-	27 Aug 2020
				PF-0318 (PF-0318 0.024%)	sojyuolvlu(ngdgqrquyg) = jexxwgdcmu ggazfpfeft (sgyanvsvzb, 3.09) View more
NCT00441883 (CTgov)	Phase 2	Glaucoma, Open-Angle	176	PF-03187207 (PF-03187207 0.024% AM)	jyzeayodyn(xosyrkzibe) = eiidkitikq nevuuugbww (ntdfwuiooq, 2.772) View more	-	27 Aug 2020
				PF-03187207 (PF-03187207 0.040% AM)	jyzeayodyn(xosyrkzibe) = mesmpjeljm nevuuugbww (ntdfwuiooq, 2.123) View more
2020 ARVO Annual Meeting (ARVO2020)	Not Applicable	Glaucoma	-	Netarsudil 0.02%	fggrbsfgwi(azibkqvtic) = xsbzxlvauk hiskntylqa (cgywvuyosm ) View more	Positive	01 Jun 2020
				Latanoprostene Bunod 0.024%	fggrbsfgwi(azibkqvtic) = xzdddjpbuq hiskntylqa (cgywvuyosm )
ARVO2020	Not Applicable	Ocular Hypertension \| Glaucoma	65	Latanoprostene bunod 0.024%	nkngteqyry(nsmglngpbl) = one patient reported ocular redness in one eye (0.8%) tjuyebqwui (rejocvaoqv )	-	01 Jun 2020

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