A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

Start Date20 Sep 2021

Sponsor / Collaborator

Tarsier Pharma Ltd.

NCT04222725

/ CompletedPhase 1/2

A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.

Start Date01 Feb 2020

Sponsor / Collaborator

Tarsier Pharma Ltd.

NCT04222712

/ CompletedPhase 1/2

A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.

Start Date01 Feb 2020

Sponsor / Collaborator

Tarsier Pharma Ltd.

100 Clinical Results associated with Dazdotuftide

100 Translational Medicine associated with Dazdotuftide

100 Patents (Medical) associated with Dazdotuftide

Literatures (Medical) associated with Dazdotuftide

01 May 2025·European Journal of Pharmacology

Tropisetron attenuates high-glucose-induced vascular endothelial dysfunction via inhibition of calcineurin/NFAT signalling

Article

Author: Ghaffari-Bohlouli, Pejman ; Nadjafi, Shabnam ; Dehpour, Ahmad Reza ; Shafiei, Massoumeh ; Barzegar-Fallah, Anita ; Alimoradi, Houman ; Razmi, Ali ; Ghaffarian-Bahraman, Ali

Vascular endothelial dysfunction (VED) is considered an important initiating factor in pathogenesis of diabetic vascular disease. In this process, oxidative insult, cellular hypertrophy, and activation of the calcineurin/nuclear factor of activated T-cell (NFAT) pathway play key roles. Herein, we investigated the effects of tropisetron (TRS), a calcineurin inhibitor, on high glucose (HG)-induced hypertrophy and apoptosis in human umbilical vein endothelial cells (HUVECs). To this end, HUVECs and chorioallantoic membranes (CAMs) were exposed to HG with or without TRS or cyclosporine A (CsA), and the effects of the treatments were evaluated on oxidative stress generation, cell number (proliferation and apoptosis), cell size (hypertrophy), and vessel formation. We also explored the possible role of calcineurin-NFAT signalling in the potential protective effects of TRS on hypertrophy and apoptosis associated with HG. The average size and protein content of the cells exposed to HG for 48h were significantly increased compared with normal glucose (NG). HG significantly increased apoptosis, altered the cell cycle, and elevated oxidative and nitrosative stress in HUVECs. Further, exposing cells to HG resulted in elevated calcineurin activity and NFATc1 translocation to the nuclei. HG also caused a significant decrease in the formation of new blood vessels in CAMs. Inhibition of calcineurin/NFAT pathway by TRS or CsA protected against these pathological changes. Our data demonstrated that inhibition of calcineurin/NFAT signalling by TRS, as a safe calcineurin inhibitor, may ameliorate HG-induced VED. Further in vivo and clinical studies are required to fully determine the protective effects of TRS against VED in diabetes.

01 Mar 2025·Plant Physiology and Biochemistry

Comprehensive analysis of small RNA, transcriptome, and degradome sequencing: Mapping the miRNA-gene regulatory network for the development of sweet potato tuber roots

Article

Author: Xiao, Dong ; Bi, Wenqing ; Zhan, Jie ; He, Longfei ; Tong, Bin ; Wang, Aiqin ; Wu, Qiang ; Chen, Yuxi

As an important starch crop, sweet potato has significant practical importance for maintaining food security worldwide. This study identified differential expressed genes associated with the expansion of tuberous roots by comparing the transcriptome across tuberous roots at the initial period (initiated tuberous roots (ITRs), rapid expansion period (tuberous roots (TRs), fibrous roots (FRs) at the seedling stage, and fibrous roots at the adult stage (unexpanded FRs (UFRs)). sRNA-seq and degradome analyses were performed to reveal the role of miRNAs in tuberous root development in sweet potato. A total of 29,633 genes and 510 miRNAs were differential expressed among FRs, ITRs, TRs, and UFRs. Integrated analyses of these data revealed genes involved in metabolism, hormone response, and signal transduction that might participate in the induction of tuberous root formation, while genes involved in carbohydrate and energy metabolism that might participate in the tuberous root swelling. A joint analysis of miRNAs and DEGs related to tuber development revealed by degradome-seq identified twelve miRNA-target gene pairs involved in gene expression process, hormone response, and metabolism of secondary metabolites that might be key regulators of root tuber development in sweet potato. Moreover, the functions of many miRNA-target gene pairs involved in the initiation of root tuber were related to auxin signaling response, and an exogenous hormone treatment experiment was further performed. The results indicated that auxin treatment had the most significant effect on increasing sweet potato yield, suggesting a dominant role of the auxin pathway in the regulation of sweet potato tuberous root development. Additionally, two miRNA-target pairs, miR319-TCP4 and miR172-AP2, which were identified from the degradome, were verified via 5' RNA ligase-mediated rapid amplification of cDNA ends (RLR-RACE) and tobacco transient cotransformation tests, and their expression was impacted by auxin treatment, which further validated the reliability of our multiomics analysis results. Our research provides new insights into the role of miRNAs in sweet potato root tuber development.

27 Jan 2025·Angewandte Chemie International Edition

Constructing Tandem Fenton‐like Reaction Systems Based on Structure Adaption to Boost Water Contaminant Mineralization Efficiency

Article

Author: Yang, Tian ; Lei, Qiuxia ; Chen, Min ; Gan, Xue ; Zhao, Hongying ; Mao, Shun

AbstractMineralization of emerging contaminants by using advanced oxidation processes (AOPs) is a desirable option to ensure water safety, but still challenged by the excessive chemical and/or energy input. Here, we conceptually proposed the tandem reaction system (TRS) of different reactive oxygen species (ROS) based on structure adaption of target contaminants. To construct a model TRS, we first realized highly selective generation of three classical ROS (1O2, HO⋅ and SO4⋅−) by peroxymonosulfate activation in an electrochemical Fenton‐like system, where three replaceable Fe‐centered cathodes were rationally designed as electronic mediator. The 1O2+SO4⋅−‐TRS exhibited nearly 100 % mineralization of sulfamethoxazole (SMX), whereas only 34.2 %, 56.2 % and 60.8 % for each of the single 1O2/HO⋅/SO4⋅−‐AOP systems. Mechanism exploration of SMX degradation in TRS evidenced that the initial reaction with 1O2 selectively destructed the sulfonamide bridge of SMX to form p‐aminobenzenesulfonic acid, which will be vulnerable to sequent SO4⋅− attack to facilitate mineralization. Successful extendibility of 1O2+SO4⋅−‐TRS to other sulfonamide antibiotics and 1O2+HO⋅‐TRS to phenolic and arylcarboxylic compounds, as well as the demonstration of 1O2+SO4⋅−‐TRS in treatment of three actual pharmaceutical wastewaters strongly support that TRS is a powerful and sustainable strategy to enhance the mineralization of emerging contaminants in water.

News (Medical) associated with Dazdotuftide

16 Jul 2024

·www.prnewswire.com

Uveitis Treatment Market Size is Estimated at $1.4 Billion by 2034, Growing at a 7% CAGR, Says Fact.MR

Investments from Pharmaceutical Entities in R&D Endeavors Increasing to Enhance Uveitis Treatment Efficacy and Patient Outcomes ROCKVILLE, Md., July 16, 2024 /PRNewswire/ -- According to a recently released industry report by Fact.MR, the global Uveitis Treatment Market is poised to be valued at US$ 791 million in 2024 and further expand at 5.8% CAGR from 2024 to 2034. Technological advancements in therapy approaches, particularly in the creation of sustained-release drug delivery devices, are key factors driving uveitis treatment market growth. Advanced treatment methods, which include biodegradable microspheres and intravitreal implants, provide significant advantages since they directly administer prolonged pharmaceutical exposure to the affected eye tissues. Reducing the need for repeated injections or systemic medications lowers the risk of undesirable systemic effects while increasing patient compliance and convenience. The rising incidence of uveitis in some countries due to the increasing aging population, a rise in the prevalence of autoimmune disorders, and a focus on improving diagnostic capabilities are major aspects driving the growth of the market for uveitis treatment. Increased funding from pharmaceutical companies and organizations for research and development initiatives aimed at uveitis treatment is driving the exploration of new medicinal agents and treatment strategies. For More Insights into the Market, Request a Sample of this Report: Key Takeaways from the Market Study The global market for uveitis treatment is projected to reach US$ 1.4 billion by 2034-end. North America is estimated to hold 36.8% of the global market share in 2024. Demand for uveitis treatment in East Asia is estimated at a market value of US$ 117 million in 2024. The Canada market is evaluated to generate revenue of US$ 90 million by 2034-end. The market in South Korea is forecasted to expand at a CAGR of 9.4% from 2024 to 2034. Based on disease, the anterior uveitis segment is forecasted to hold 59.5% of the global market share by 2034. In the North American region, the United States is expected to lead the market with a 73.4% revenue share in 2024. "Revenue from uveitis treatment is growing at a steady pace as a result of ongoing advancements such as sustained-release medication delivery techniques that improve patient convenience and therapeutic efficacy," says a Fact.MR analyst. Leading Players Driving Innovation in the Uveitis Treatment Market Key players in the uveitis treatment industry are Sun Pharmaceutical Industries Ltd., EyePoint Pharmaceuticals, Inc., Ophthotech Corporation, Regeneron Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited, Inflammasome Therapeutics Inc., Graybug Vision, Inc., TopiVert Pharma Ltd., Pfizer Inc., Bausch Health Companies Inc. Hospital Pharmacies Account for Substantial Market Share Hospital pharmacies are generating substantial revenue compared to other distribution channels such as retail pharmacies, online pharmacies, and drug stores. Hospital pharmacies face a constant need for uveitis medications since uveitis is a fairly common condition that requires ongoing care and because hospitals often have a big patient base. Hospitals benefit financially from treating an increasing number of uveitis patients who require continuous access to the prescribed medications. Hospital pharmacies benefit from discounted rates on these medications due to contracts with specific suppliers of uveitis medications. Uveitis Treatment Industry News: Targeting non-infectious uveitis, including uveitic glaucoma, Tarsier Pharma received FDA permission in January 2024 for the Tarsier-04 Phase 3 trial of the TRS01 ocular solution under the Special Protocol Assessment (SPA). The FDA approved triamcinolone acetonide injectable suspension, or XIPER, in October 2021 for use as a suprachoroidal medication to treat retinal edema associated with uveitis. Targeting non-infectious posterior segment uveitis (NIPU) and diabetic macular edema (DME), Alimera Sciences Europe Ltd. launched ILUVIEN in the Netherlands in December 2020 to expand geographically to reach more doctors and patients. Get Customization on this Report for Specific Research Solutions: Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Treatment: Corticosteroids Immunosuppressants Monoclonal Antibodies Cycloplegic Agents Antibiotics Antivirals Antifungals Analgesics Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Disease: Anterior Uveitis Posterior Uveitis Intermediate Uveitis Panuveitis Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Cause: Infectious Uveitis Non-infectious Uveitis Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Distribution Channel: Hospital Pharmacies Retail Pharmacies Online Pharmacies Drug Stores More Valuable Insights: Fact.MR, in its new offering, presents an unbiased analysis of the uveitis treatment market, presenting historical demand data (2019 to 2023) and forecast statistics for 2024 to 2034. The study divulges essential insights into the market based on treatment (corticosteroids, immunosuppressants, monoclonal antibodies, cycloplegic agents, antibiotics, antivirals, antifungals, analgesics), disease (anterior uveitis, posterior uveitis, intermediate uveitis, panuveitis), cause (infectious uveitis, non-infectious uveitis), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies, drug stores), across seven major regions of the world (North America, Western Europe, Eastern Europe, East Asia, Latin America, South Asia & Pacific, and MEA). Check out More Related Studies Published by Fact.MR: Eye Health Supplements Market stands at US$ 1.9 billion in 2023 and is forecasted to reach US$ 3.5 billion by the end of 2033, increasing at a CAGR of 6.2%. Dry Eye Syndrome Treatment Market is anticipated to be worth US$ 4,027.2 million in 2024 and is expected to expand to an astounding size of US$ 10,961.2 million by 2034. Rare Neurological Disease Treatment Market is projected to expand at a stellar CAGR of over 8.5% and is anticipated to grow 2.3x between 2018 and 2028. Ophthalmic Drugs Market is valued at US$ 38 billion in 2023 and is thus anticipated to reach US$ 72 billion by 2033. Ocular Drug Delivery Technology Market is poised to flourish at a CAGR of 8.2% to reach a value of US$ 39 Billion by 2032. Refsum Disease Treatment Market is predicted to accelerate at a CAGR of 5.6% and reach a market valuation of US$ 2.56 billion by the end of 2033. About Us: Fact.MR is a distinguished market research company renowned for its comprehensive market reports and invaluable business insights. As a prominent player in business intelligence, we deliver deep analysis, uncovering market trends, growth paths, and competitive landscapes. Renowned for its commitment to accuracy and reliability, we empower businesses with crucial data and strategic recommendations, facilitating informed decision-making and enhancing market positioning. With its unwavering dedication to providing reliable market intelligence, FACT.MR continues to assist companies in navigating dynamic market challenges with confidence and achieving long-term success. With a global presence and a team of experienced analysts, FACT.MR ensures its clients receive actionable insights to capitalize on emerging opportunities and stay competitive. Contact: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 Sales Team: [email protected] Follow Us: LinkedIn | Twitter | Blog SOURCE Fact.MR

Drug ApprovalPhase 3

28 May 2024

·www.prnewswire.com

Tarsier Pharma Announces the Appointment of Emilee Fulcher as Vice President of Clinical Affairs

TEL-AVIV, Israel, May 28, 2024 /PRNewswire/ -- Tarsier Pharma, Ltd, a late-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases proudly announces the appointment of Emilee Fulcher as Vice President of Clinical Affairs. Continue Reading Emilee Fulcher, VP Clinical Affairs, Tarsier Pharma Ltd. In her new role, Emilee Fulcher will spearhead the execution of the TRS01 and TRS02 clinical programs towards the advancement of Tarsier Pharma's pipeline for Dazdotuftide (TRS). Dazdotuftide is a novel, multi-target drug with a unique mechanism of action in development for the treatment of ocular blinding diseases as an eye drop formulation (TRS01) and slow-release biodegradable intravitreal injection (TRS02). "We are thrilled to welcome Emilee to the Tarsier team as our Vice President of Clinical Affairs," said Daphne Haim-Langford CEO of Tarsier. "Emilee's exceptional leadership, proven track record, and deep understanding of ophthalmic research make her the ideal candidate to lead our clinical development efforts. She is knowledgeable, professional, deeply compassionate, and fully aligned with the company's vision to save sight, which makes her an invaluable asset to the team". Emilee has 20 years of experience in the pharmaceutical industry with a specialized background in executing ophthalmology clinical trials. Prior to joining Tarsier, Emilee was one of the first employees of Lexitas, an ophthalmic-focused CRO. During her 11-year tenure at Lexitas she successfully led trials spanning across multiple ophthalmic indications and phases, including all three trials in the TRS01 clinical program completed to-date. Prior to that, she held positions in preclinical drug development and in clinical operations at UCB Biosciences and Inspire Pharmaceuticals. Emilee stated "I am deeply honored to officially join the talented team at Tarsier and am excited to leverage my expertise as we strive to bring our innovative treatment to patients. I am passionate about our mission at Tarsier and eager to progress our clinical programs that have the potential to revolutionize the treatment paradigm for patients with debilitating and blinding conditions including uveitis and specifically uveitic glaucoma. As we embark on initiating the Tarsier-04 Phase 3 trial, we are poised to build on the momentum of our recently completed TRS4Vision Phase 3 trial that demonstrated the potential of TRS01 to serve as an effective and safe treatment in uveitis that meets the urgent need for a drug that resolves inflammation and with a superior IOP safety profile." Tarsier Pharma congratulates Emilee Fulcher on her appointment and looks forward to her leadership in driving the company's clinical development efforts forward. Photo: Contact: Investor Relations Tarsier Pharma [email protected] SOURCE Tarsier Pharma

Executive ChangePhase 3

06 Mar 2024

·www.businesswire.com

Global Anterior Uveitis (Iritis) Drug Pipeline Research Report 2024 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Anterior Uveitis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anterior Uveitis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anterior Uveitis pipeline landscape is provided which includes the disease overview and Anterior Uveitis treatment guidelines. The assessment part of the report embraces, in depth Anterior Uveitis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anterior Uveitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Anterior Uveitis R&D. The therapies under development are focused on novel approaches to treat/improve Anterior Uveitis Anterior Uveitis Emerging Drugs Chapters This segment of the Anterior Uveitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Anterior Uveitis Emerging Drugs TRS01: Tarsier Pharma Dazdotuftide (formerly known as TRS01) is a first-in-class drug with a new and unique mechanism of action, for the treatment of ocular blinding diseases of back- and front- of the eye. Dazdotuftide is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action. Dazdotuftide was found to modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2). Due to dazdotuftide's unique mechanism of action of immunomodulation, it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. Currently, the drug is Phase III stage of its clinical trial for the treatment of anterior uveitis. Anterior Uveitis Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anterior Uveitis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anterior Uveitis drugs. Anterior Uveitis Therapeutic Assessment Major Players in Anterior Uveitis There are approx. 3+ key companies which are developing the therapies for Anterior Uveitis. The companies which have their Anterior Uveitis drug candidates in the most advanced stage, i.e. Phase III include, Tarsier Pharma. Phases: The report covers around 3+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Anterior Uveitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Anterior Uveitis Report Insights Anterior Uveitis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Anterior Uveitis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Tarsier Pharma Oculis Pharma Novaliq Key Products TRS01 OCS 2 Tacrolimus For more information about this clinical trials report visit https://www.researchandmarkets.com/r/tkzvsx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Gene Therapy

100 Deals associated with Dazdotuftide

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Indication	Highest Phase	Country/Location	Organization	Date
Uveitis, Anterior	Phase 3	Israel	Tarsier Pharma Ltd.	30 Jan 2022
Non-infectious anterior uveitis	Phase 3	Germany	Tarsier Pharma Ltd.	20 Sep 2021
Non-infectious anterior uveitis	Phase 3	United States	Tarsier Pharma Ltd.	20 Sep 2021
Non-infectious anterior uveitis	Phase 3	France	Tarsier Pharma Ltd.	20 Sep 2021
Uveitic Glaucoma	Phase 3	France	Tarsier Pharma Ltd.	20 Sep 2021
Uveitic Glaucoma	Phase 3	Germany	Tarsier Pharma Ltd.	20 Sep 2021
Uveitic Glaucoma	Phase 3	United States	Tarsier Pharma Ltd.	20 Sep 2021
Diabetic macular oedema	Preclinical	Israel	Tarsier Pharma Ltd.	30 Jan 2022
dry age-related macular degeneration	Preclinical	Israel	Tarsier Pharma Ltd.	30 Jan 2022
Ocular inflammation	Discovery	United States	Tarsier Pharma Ltd.	01 Feb 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04222712 (CTgov)	Phase 1/2	Non-infectious anterior uveitis	16	TRS01 eye drops (TRS01 Low Dose)	nlmvpstkwn(oxoujzousx) = nkmmspaeha azxvcseeor (cigwtgbpam, kirieyhueb - xbxoqadhtl) View more	-	05 Oct 2023
				TRS01 eye drops (TRS01 High Dose)	nlmvpstkwn(oxoujzousx) = cohdujqpre azxvcseeor (cigwtgbpam, sjyqjkvsck - xuioaadifx) View more
NCT04222725 (CTgov)	Phase 1/2	Ocular inflammation	37	TRS01 eye drops (TRS01 Low Dose)	vlauchshed(inuzahbskm) = forhmwyogr djsplkngmh (ecnzucxsyd, ikwzyfngrf - ixfnfcpjih) View more	-	14 Oct 2021
				TRS01 eye drops (TRS01 Medium Dose)	vlauchshed(inuzahbskm) = phnqbbgrgd djsplkngmh (ecnzucxsyd, fbsimukreg - pqqlebyewj) View more

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