Delving into the Latest Updates on Diquafosol Sodium with Synapse

Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28

Start Date15 Aug 2024

Sponsor / Collaborator

Liaoning He Eye Hospital Group Co., Ltd.

JPRN-UMIN000052920 / SuspendedIIT

Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops: A Prospective Randomized Non-Blind Intervention Study - Comparison of Adherence Between Diquas LX3% Eye Drops and Diquas 3% Eye Drops

Start Date01 Feb 2024

Sponsor / Collaborator

Juntendo University

NCT05682547 / Not yet recruitingNot Applicable

A Single Center, Randomized, Controlled Trial Comparing the Clinical Efficacy of 3% Diquafosol Tetrasodium and 0.1 % Hyaluronic Acid 0.1% in Diabetic Patients With Dry Eye Disease

Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells. Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function. While it has been observed that 0.1 percent hyaluronate (HA) in artificial tears promotes corneal re-epithelium and improves corneal healing.This prospective, open label pilot study will include 60 eyes of 30 diabetic patients diagnosed with DED and will be randomly assigned to either DQS (n=30 eyes) or ATD group (n=30 eyes). Participants in the DQS group will receive 3% Diquafosol ophthalmic solution, while HA group will receive 0.1% Sodium hyaluronate artificial tears. The dosage for both drugs will be one drop, six times per day for 4 weeks. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), meibum gland (MG), conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.

Start Date01 Nov 2023

Sponsor / Collaborator

Liaoning He Eye Hospital Group Co., Ltd.

100 Clinical Results associated with Diquafosol Sodium

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100 Translational Medicine associated with Diquafosol Sodium

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100 Patents (Medical) associated with Diquafosol Sodium

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201

Literatures (Medical) associated with Diquafosol Sodium

01 Sep 2024·Journal of Controlled Release

Rosmarinic acid-grafted gelatin nanogels for efficient diquafosol delivery in dry eye disease therapy

Article

Author: Zhou, Tinglian ; Yao, Ke ; Han, Haijie ; Lv, Zeen ; Zhu, Jiayan ; Zhang, Mingxuan ; Li, Su ; Zeng, Guixiang

Dry eye disease (DED) is a prevalent ocular disorder characterized by unstable tear film condition with loss of aqueous or mucin, excessive oxidative stress, and inflammation, leading to discomfort and potential damage to the ocular surface. Current DED therapies have shown restricted therapeutic effects such as frequent dosing and temporary relief with potential unwanted side effects, urgently necessitating the development of innovative efficient therapeutic approaches. Herein, we developed rosmarinic acid (RosA) conjugated gelatin nanogels loading diquafosol sodium (DQS), DRGNG, for simultaneous ROS-scavenging and mucin-secreting DED treatment. Mechanically, DRGNG suppressed the ROS production, reduced inflammatory factors, and prompted mucin secretion in vitro and in vivo. The whole transcriptome RNA sequencing in vitro further provided a detailed analysis of the upregulation of anti-oxidant, anti-inflammatory, and mucin-promotion pathways. Therapeutically, both in evaporative DED and aqueous deficient DED models, the dual-functional DRGNG could prolong the retention time at the ocular surface, efficiently suppress the oxidative stress response, reverse ocular surface morphology, and recover tear film homeostasis, thus alleviating the DED when the dosage is halved compared to the commercial Diquas®. Our findings contribute to developing innovative therapies for DED and offer insights into the broader applications of nanogels in ocular drug delivery and oxidative stress-related conditions.

01 Aug 2024·Journal of Ocular Pharmacology and Therapeutics

Effects of Diquafosol Sodium Ophthalmic Solution on Tear Film Matrix Metallopeptidase-9 and Corneal Nerve Density in Patients with Type 2 Diabetic Dry Eye

Article

Author: Wu, Yi ; Moutari, Salissou ; Xu, Ling ; He, Xingru ; Qin, Guanghao ; Li, Liangzhe ; You, Yue ; Bu, Shaochong ; Pazo, Emmanuel Eric ; Moore, Jonathan E ; Yang, Lanting ; He, Wei ; Zhang, Qing ; Chen, Yimeng ; Yu, Sile ; Guo, Naici ; Chen, Jiayan ; Qi, Yifan

Purpose: Diabetes mellitus has been associated with increased dry eye disease (DED) and exacerbates DED's pathology. This preliminary short-term study aimed to evaluate the effects of 3% Diquafosol Sodium ophthalmic solution (DQS) on ocular surface inflammation and corneal nerve density in diabetic dry eye (DDE) patients. Methods: In this perspective, participants used 1 drop of 3% DQS (Diquas; Santen Pharmaceutical Co., Ltd., Osaka, Japan) 6 times daily for 8 weeks. Non-invasive tear breakup time (NITBUT), tear film lipid layer (TFLL), conjunctival hyperemia [redness score (RS)], corneoconjunctival staining (CFS), corneal sensitivity (CS), Meibomian gland quality (MGQ) and Meibomian gland expressibility (MGEx), corneal nerve fiber density (CNFD), and Standard Patient Evaluation Eye Dryness (SPEED) questionnaire were assessed at baseline, at weeks 4, and up to 8 weeks. Matrix metalloproteinase-9 (MMP-9) of tear samples was measured at baseline and weeks 8. Results: The mean age was 61.27 ± 11.68 years. At baseline NITBUT = 5.89 ± 2.81 s, tear meniscus height = 0.17 ± 0.05 mm, TFLL = 2.74 ± 0.51, CFS = 4.35 ± 0.68, CS = 53.83 ± 9.63 mm, MMP-9 = 49.10 ± 10.42 ng/mL, RS = 1.65 ± 0.44, MGEx = 1.85 ± 0.72, MGQ = 2.65 ± 0.50, CNFD = 20.36 ± 8.20 no./mm², and SPEED = 12.62 ± 3.91. At week 4, significant improvements were found in all parameters except RS (1.59 ± 0.46, P = 0.172) and CNFD (21.46 ± 8.41, P = 0.163). Finally, at week 8, all parameters had significant improvements. Conclusion: Preliminary short-term findings suggest that treatment of DDE patients with DQS was found to be safe and efficacious in improving dry eye parameters. In addition, inflammatory marker and corneal nerve density were significantly improved. This study was registered with ClinicalTrials.gov (NCT05193331).

10 Jul 2024·ACS Applied Materials & Interfaces

Multifunctional Cerium Oxide Nanozyme for Synergistic Dry Eye Disease Therapy

Article

Author: Xu, Baoqi ; Lin, Quankui ; Wang, Yajia ; Hong, Yueze ; Wang, Mengting ; Xie, Hongying ; Zou, Haoyu

Dry eye disease (DED) is a chronic multifactorial ocular surface disease mainly caused by the instability of tear film, characterized by a series of ocular discomforts and even visual disorders. Oxidative stress has been recognized as an upstream factor in DED development. Diquafosol sodium (DQS) is an agonist of the P2Y₂ receptor to restore the integrity/stability of the tear film. With the ability to alternate between Ce³⁺ and Ce⁴⁺, cerium oxide nanozymes could scavenge overexpressed reactive oxygen species (ROS). Hence, a DQS-loaded cerium oxide nanozyme was designed to boost the synergistic treatment of DED. Cerium oxide with branched polyethylenimine-graft-poly(ethylene glycol) as nucleating agent and dispersant was fabricated followed with DQS immobilization via a dynamic phenylborate ester bond, obtaining the DQS-loaded cerium oxide nanozyme (defined as Ce@PBD). Because of the ability to mimic the cascade processes of superoxide dismutase and catalase, Ce@PBD could scavenge excessive accumulated ROS, showing strong antioxidant and anti-inflammatory properties. Meanwhile, the P2Y₂ receptors in the conjunctival cells could be stimulated by DQS in Ce@PBD, which can relieve the incompleteness and instability of the tear film. The animal experiments demonstrated that Ce@PBD significantly restored the defect of the corneal epithelium and increased the number of goblet cells, with the promotion of tear secretion, which was the best among commercial DQS ophthalmic solutions.

2

News (Medical) associated with Diquafosol Sodium

27 Apr 2023

·www.biospace.com

Yuyu Pharma, Dry Eye Pipeline Mechanism of Action and Pre-clinical Results Published

SEOUL, South Korea, April 27, 2023 /PRNewswire/ -- At ARVO 2023, Yuyu Pharma unveiled the results of its mechanism of action and head-to- head studies for its dry eye treatment peptide (project name: YP-P10). ARVO is the world's largest ophthalmic society and held its annual meeting in New Orleans, Louisiana, USA in April of this year. A study conducted by Dr. Virginia Calder of the University College London (UCL) found that YP-P10 significantly reduces inflammatory Th2 and Th17 cells. In particular, the YP-P10 model reduced Th17 cells 25% more effectively when compared to the control group. The YP-P10 pre-clinical head-to-head study, jointly conducted by five people including Dr. Kyungho Park of Naason Science, showed statistically significant reduction of corneal damage by measuring Corneal Fluorescein Staining (CFS). The study compared the efficacy of YP-P10 to that of several competing dry eye treatment products such as Lifitegrast, Cyclosporine, Diquafosol, and Hyaluronic Acid. The results showed that YP-P10 had 12% better efficacy than Lifitegrast, 7% better than Cyclosporine, 9 % better than Hyaluronic Acid, and showed similar efficacy to Diquafosol. Yuyu Pharma's Director of Business Development, Laxmikant Neil Gharat said, "Through this ARVO presentation, ophthalmologists and global pharmaceutical companies have once again confirmed their interest in YP-P10. We plan to announce the results of YP-P10's phase 2 clinical trial in the first half of this year." Yuyu Pharma anticipates that YP-P10 will be an effective treatment and has completed patent registration in 4 countries (USA, Korea, Australia, Russia) with patent applications pending in 11 other countries. About YP-P10 Ophthalmic Solution YP-P10 is a novel, patented, synthetic peptide with anti-inflammatory properties being explored for the potential treatment of dry eye disease (DED). In April 2022, Yuyu received clearance from the U.S. Food & Drug Administration (FDA) that enabled the company to initiate the phase 2 clinical study, ICECAP, to evaluate the safety, tolerability and efficacy of YP-P10 Ophthalmic Solution in patients with DED. ICECAP is Yuyu's first biopharmaceutical clinical trial within the United States. About Yuyu Pharma With over 80 years in the healthcare industry, Yuyu Pharma (KRX: 000220) is a rapidly scaling global pharmaceutical company founded in Seoul, South Korea. Yuyu is committed to developing innovative therapeutics in the areas of neurology, dermatology, urology, and ophthalmology. For additional information about Yuyu Pharma and YP-P10, please visit YuyupharmaUS.com. Media contact: Sean Yoon, hjyoon@yuyu.co.kr View original content to download multimedia: SOURCE Yuyu Pharma Company Codes: Korea:000220

Clinical ResultPhase 2Phase 1

21 Jun 2022

·www.biospace.com

Opus Genetics Appoints Ben Yerxa, Ph.D., as Permanent Chief Executive Officer

Industry veteran and experienced CEO will continue to lead the company as its AAV-based gene therapies for inherited retinal diseases approach the clinic RESEARCH TRIANGLE PARK, N.C., June 21, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first gene therapy company developing treatments for inherited retinal diseases, today announced the appointment of Ben Yerxa, Ph.D., as Chief Executive Officer (CEO). Dr. Yerxa previously served as acting CEO of Opus, in addition to former roles as CEO of the Foundation Fighting Blindness and the Retinal Degeneration (RD) Fund, the venture arm of the Foundation focused on making venture philanthropy investments to further the Foundation’s mission of accelerating research for preventing, treating and curing blinding diseases. Opus is the first spin-off company internally conceived and launched by the RD Fund, and combines unparalleled insight and commitment to patient need with wholly owned AAV-based gene therapy programs in inherited retinal diseases, while creating novel manufacturing scale and efficiencies tailored for producing rare disease therapeutics. “I’m exceptionally proud of the progress we’ve made toward our mission during my nearly five years at the Foundation, including the launch of the RD Fund to further the Foundation’s mission through venture philanthropy,” said Dr. Yerxa. “Stepping into the permanent CEO role at Opus Genetics – a company that we created and launched through the RD Fund – enables me to be on the front line of bringing potentially life-changing treatments to the patients who so urgently need them.” Dr. Yerxa continued, “More than 280 genes are known to cause inherited retinal diseases, and it’s estimated that over 180,000 patients are waiting for treatments for their individual genetic conditions. Opus is combining the best instruments of science with patient need to grow and advance our pipeline of AAV-based gene therapies for inherited retinal diseases, and I’m pleased to continue leading the Opus team in this important work.” Dr. Yerxa has more than 25 years’ experience in biotechnology, nonprofit and drug development and in translating promising research discoveries into clinical milestones and commercial launches in the ophthalmology, pulmonary, rare disease, cardiovascular and HIV fields. He has been involved with the discovery and development of nine investigational new drugs, four Phase 3 clinical programs, two new drug applications and two drug approvals. Prior to joining the Foundation, Dr. Yerxa served as president and co-founder of Envisia Therapeutics, a company focused on developing novel ocular sustained delivery therapies for the front and back of the eye. He also has previously held founding and executive positions in several ophthalmology-based R&D organizations, including Liquidia Technologies, Clearside Biomedical, Parion Sciences and Inspire Pharmaceuticals. “Opus is entering a pivotal time in its evolution as our first program, OPGx-001 to address mutations in the LCA5 gene, is expected to enter the clinic this year, bringing a potential treatment another step closer to patients in need,” said Jean Bennett, M.D., Ph.D., Opus scientific founder, board director and scientific advisory board member. “As a founder of the RD Fund and Opus, Ben is uniquely well-suited to realize Opus’ potential to tackle some of the most neglected forms of inherited blindness and make a real difference in the lives of patients.” Dr. Yerxa holds 60 U.S. patents and is an inventor of DIQUAS™, an innovative treatment for dry eye approved in Japan. Dr. Yerxa earned his Ph.D. in organic chemistry from University of California, Irvine, and BA in chemistry from the University of California, San Diego. About Opus Genetics Opus Genetics is a groundbreaking gene therapy company for inherited retinal diseases with a unique model and purpose. Backed by Foundation Fighting Blindness’s venture arm, the RD Fund, Opus combines unparalleled insight and commitment to patient need with wholly owned programs in numerous orphan retinal diseases. Its AAV-based gene therapy portfolio tackles some of the most neglected forms of inherited blindness while creating novel orphan manufacturing scale and efficiencies. Based in Research Triangle Park, N.C., the company leverages knowledge of the best science and the expertise of pioneers in ocular gene therapy to transparently drive transformative treatments to patients. For more information, visit . Media Contact: Heather Anderson 6 Degrees 919-827-5539 handerson@6degreespr.com

Gene Therapy

100 Deals associated with Diquafosol Sodium

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KEGG	Wiki	ATC	Drug Bank
D03864	Diquafosol Sodium	S02AA	DB15919

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dry Eye Syndromes	KR	Santen Pharmaceutical Co., Ltd.	30 Dec 2011
Xerophthalmia	JP	Santen Pharmaceutical Co., Ltd.	16 Apr 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cataract	Phase 2	ID	Santen Pharmaceutical Co., Ltd.	02 Oct 2022
Dry Eye Syndromes	Preclinical	US	Inspire Pharmaceuticals, Inc.	-
Dry Eye Syndromes	Preclinical	SG	Santen Pharmaceutical Co., Ltd.	-
Pulmonary Disease, Chronic Obstructive	Preclinical	US	-	-
Pulmonary Disease, Chronic Obstructive	Preclinical	GB	-	-
Kerato conjunctivitis sicca	Discovery	-	Merck Sharp & Dohme Corp.	01 Apr 2002

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05193331 (Pubmed \| J Ocul Pharmacol Ther)	Not Applicable	Matrix metalloproteinase-9 (MMP-9)	-	3% Diquafosol Sodium ophthalmic solution	nyygubercl(enguieospo) = kixepkhgch snfgcmvbyh (pprxmzmdzd ) View more	Positive	13 Dec 2023
WCD2023	Not Applicable	Dermatitis, Atopic	-	Diquafosol group	(eippoemsnj) = voltxxdqka ohlhtbgecf (zsxgrddgin )	-	03 Jul 2023
NCT04980144 (Pubmed \| Am J Ophthalmol)	Not Applicable	Xerophthalmia \| Diabetes Mellitus, Type 2	30	Diquafosol ophthalmic solution	(fsshfuvvtq) = zuqklngher opwlltajdn (gtyauhuouj ) View more	Positive	19 Jan 2022
				Hyaluronate	(fsshfuvvtq) = zncwbtepzk opwlltajdn (gtyauhuouj ) View more
ARVO2018	Not Applicable	Dry Eye Syndromes	-	3% diquafosol ophthalmic solution	(ynkgrileyy) = dtbcqkluye onizjjykmg (mwtuxtelap )	-	01 Jul 2018
				Artificial tears	(ynkgrileyy) = zoezavspsz onizjjykmg (mwtuxtelap )
NCT04980144 \| NCT05682547 \| NCT05193331 (Pubmed)	Not Applicable	Dry Eye Syndromes \| Meibomian Gland Dysfunction	-	Topical 3% diquafosol sodium	ewsxluunfu(seewmhosbv) = izktayqnno megceyhjog (nrvjynlebu )	-	01 Jan 2017
NCT02608489 (CTgov)	Not Applicable	Dry Eye Syndromes	86	Diquafosol (Diquas) (Diqufosol)	txnzzgrcsa(nfircxmvjh) = xxevnzcoan ulvkkkvgaw (xrcclntjaq, ndfsyofhuu - gknecdtjqj) View more	-	17 Oct 2016
				Sodium Hyaluronate (Hyalein) (Hyaluronate)	txnzzgrcsa(nfircxmvjh) = mnscimuieh ulvkkkvgaw (xrcclntjaq, ldiucwmjbf - jxktehfzmr) View more
PO048 (AAO2015)	Not Applicable	Dry Eye Syndromes	-	3% Diquafosol Ophthalmic Solutions	hsyranlome(hnuhupkret) = tupyaipdix eqnkbagbws (hqyyhbsomm, 2.0)	Positive	15 Nov 2015
				Normal Saline	hsyranlome(hnuhupkret) = hfipyscxvy eqnkbagbws (hqyyhbsomm, 2.2)
NCT01101984 (Pubmed \| Br J Ophthalmol) Manual	Not Applicable	Dry Eye Syndromes	497	diquafosol ophthalmic solution	cxkbhronmn(vdrjvgvhjl) = glnezvipnt cghryweetb (iyhedpcgfu, 1.5) View more	Positive	01 Jul 2015
				sodium hyaluronate ophthalmic solution	(ixqbdpfxpo) = phhhwcxonu kzpwrzfrrt (ujlabhirgy ) View more
NCT01189032 (CTgov)	Phase 2	Dry Eye Syndromes	320	Placebo ophthalmic solution (Placebo)	sdzdpcgalg(knjqhzvbwy) = vuevylkesb kdozskdfhn (vndavxfwcx, hfduoplbyv - entvdnxlgc) View more	-	08 Aug 2014
				DE-089 ophthalmic solution (Low Concentration)	sdzdpcgalg(knjqhzvbwy) = gnjetaeqar kdozskdfhn (vndavxfwcx, tjwqlzztyb - kfxskychtx) View more
NCT01240382 (CTgov)	Phase 3	Dry Eye Syndromes	332	3% DE-089 ophthalmic solution (3% DE-089)	jskwstuuaa(bcgexqbozk) = ejkoljiphk ryhubuthpp (bcburqnsmp, anwgonajth - wnpdbpwbww) View more	-	08 Aug 2014
				0.1% sodium hyaluronate ophthalmic solution (0.1% HA)	jskwstuuaa(bcgexqbozk) = yeepdsoict ryhubuthpp (bcburqnsmp, biiluvnylg - awfgyjtxyg) View more