Tarsier Pharma Ltd.

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.

TEL AVIV, Israel , Jan. 16, 2024 /PRNewswire/ -- Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial to evaluate TRS01 eye drops for the treatment of non-infectious uveitis including uveitic glaucoma. Continue Reading Daphne Haim-Langford, Ph.D, Founder & CEO Tarsier Pharma Ltd. A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application. "The SPA agreement with the FDA provides a clear regulatory path for TRS01. The approved protocol of the upcoming Tarsier-04 trial was designed to replicate the TRS4Vision trial, with revised endpoints that are aimed to emphasize the benefit/risk profile of TRS01, based on lessons learned from the TRS4Vision trial", said Daphne Haim-Langford, Ph.D, Founder and CEO of Tarsier. "The primary endpoint in this FDA approved protocol is one that achieved an alpha <0.01 in the TRS4Vision trial, thus we have strong reasons to believe that the endpoints of Tarsier-04 will be met, and this SPA agreement with the FDA is bringing TRS01 much closer to patients in need". "Patients dealing with non-infectious uveitis endure a lifelong struggle to safeguard their vision. Despite current treatments, a majority of patients eventually suffer vision loss, significantly impacting their quality of life. The fear of blindness, affecting 22% of patients, adds another layer of devastation," stated Prof. Palestine. Director, Center for Ocular Inflammation at the University of Colorado Department of Ophthalmology. "Presently, there are no FDA-approved, steroid-free topical medications for this condition. An eye drop product that effectively resolves inflammation without raising intraocular pressure is a long standing, so far unachievable, goal in our field. After over 40 years of treating non-infectious uveitis and actively participating in efforts to develop new therapies, drawing confidence from the positive outcomes of the TRS4Vision trial I'm optimistic that we're closer than ever to controlling inflammation without increasing the risk of glaucoma and that TRS01 can serve as a new first-line-treatment for non-infectious uveitis replacing topical steroids." Tarsier received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the Tarsier-04 Phase 3 trial of TRS01 address objectives supporting regulatory submission and a potential future marketing application in this indication. Tarsier-04 will be a multi-center, randomized, double-masked, active-controlled Phase 3 trial designed to evaluate the efficacy and safety of TRS01 eye drops in non-infectious uveitis including patients with uveitic glaucoma, and is planned to enroll up to 300 patients in the U.S. "We are grateful for the FDA's professional support and guidance", said Ms. Zohar Milman, M.Sc, COO of Tarsier. "With this swift agreement, we are now focused on gearing up preparations toward the trial start-up activities.". About Tarsier Pharma Tarsier Pharma is a clinical stage biopharmaceutical company, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat immune-mediated blinding diseases in the front and back of the eye. About TRS01 Dazdotuftide (formerly known as TRS) 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). Tarsier is developing dazdotuftide as an eye drop formulation (TRS01) for front-of-the-eye indications and as a slow-release biodegradable intravitreal injection (TRS02) targeting back-of-the-eye blinding indications with an underlying inflammatory pathology, such as Diabetic Macular Edema, Non-Proliferative Diabetic Retinopathy, and others. Due to dazdotuftide's unique mechanism of action of immunomodulation, we believe it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. About Uveitic Glaucoma Non-infectious uveitis is a chronic autoimmune disease of the eye and the third leading cause of blindness. Despite available treatment options, 67% of patients suffering from non-infectious uveitis reaching visual impairment and 22% are meeting a legal blindness criterion. The current treatment for active non-infectious anterior uveitis is topical steroids. Since their introduction to the eye 70 years ago, topical steroids have been used as first line treatment due to their potency in resolving inflammation. While potent in resolving inflammation, topical steroids carry a high risk of intraocular pressure (IOP) elevation mediated by steroids' receptors, and often if treatment is ceased without long tapering period, a recurrent rebound inflammation occurs. In some patients, IOP elevation leads to glaucoma (i.e., uveitic glaucoma). Uveitic glaucoma is a challenging disease to treat, with a unique pathophysiology, disease course, prognosis, and a significantly more difficult clinical course to manage than anterior uveitis without glaucoma. The overall prevalence of glaucoma in eyes with uveitis (i.e., uveitic glaucoma) varies from 10 to 20 percent but is much more common in chronic uveitis and can be as high as 46 percent. For more information, visit . Contact: Daphne Haim-Langford, Ph.D Founder & CEO [email protected] Photo - SOURCE Tarsier Pharma

Agreement on registrational program's primary and key secondary Endpoint to reflect TRS01 positive risk/benefit profile for patients with noninfectious uveitis and uveitic glaucomaTRS01 has the potential to be the first line treatment option for noninfectious uveitis and specifically uveitic glaucoma TEL-AVIV, Israel, Nov. 13, 2023 /PRNewswire/ -- Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced the successful outcome of a Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of TRS01 eye drop formulation for the treatment of noninfectious uveitis into a registrational program based on the recently completed TRS4Vision trial. Continue Reading Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine, and Pediatrics at the Byers Eye Institute, Stanford University School of Medicine, and the President of the International Ocular Inflammation Society (IOIS) "We are pleased to have FDA agreement on the primary and key secondary endpoints for the registrational program of TRS01 which we believe has the potential to be first-in-class first line treatment for noninfectious uveitis and specifically in uveitic glaucoma" said Zohar Milman, MSc. Chief Operational Officer of Tarsier. "We are grateful for the FDA's support and guidance and look forward to continue the professional discussions as we advance TRS01 development." The Type C meeting was supported by results from the previously completed TRS4Vision trial – a randomized, double-masked, active-controlled Phase 3 trial that was designed to evaluate the efficacy and safety of TRS01 eye drop formulation in noninfectious uveitis patients including uveitic glaucoma patients. In the TRS4Vision trial, TRS01 was found to be active in clearing inflammation, reducing ocular pain and exhibited a compelling risk/benefit profile, minimizing the concerns of Intraocular Pressure (IOP) increase during the course of treatment. The upcoming trial is intended to replicate the TRS4Vision trial, with a revised endpoints in accordance with FDA discussions. The revised endpoints specifically designed to emphasize the risk/benefit profile of TRS01. The primary endpoint chosen has already attained statistical significance in the TRS4Vision trial, with a p-value <0.01. "The results from the TRS4Vision trial demonstrates that TRS01 has a positive risk/benefit profile for the most vulnerable eyes that already reached the stage of uveitic glaucoma," stated Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine, and Pediatrics at the Byers Eye Institute, Stanford University School of Medicine, and who is an international leader in Uveitis and Ocular Inflammatory Diseases and the President of the International Ocular Inflammation Society (IOIS) "There is growing evidence on the substantial risk of increased IOP in uveitis and a clear understanding that we need a steroid-free first line treatment for the active phase of anterior non-infectious uveitis. The data thus far support that the TRS01 profile has the potential to slow or prevent clinically meaningful progression of glaucoma in noninfectious uveitis and serve as first line treatment in uveitic glaucoma," said Professor Nguyen. About Tarsier Pharma Tarsier Pharma is a clinical stage biopharmaceutical company, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat immune-mediated blinding diseases in the front and back of the eye. About TRS01 Dazdotuftide (formerly known as TRS) 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). Tarsier is developing dazdotuftide as an eye drop formulation (TRS01) for front-of-the-eye indications and as a slow-release biodegradable intravitreal injection (TRS02) targeting back-of-the-eye blinding indications with an underlying inflammatory pathology, such as Diabetic Macular Edema, Non-Proliferative Diabetic Retinopathy, and others. Due to dazdotuftide's unique mechanism of action of immunomodulation, we believe it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. About Uveitic Glaucoma Non-infectious uveitis is a chronic autoimmune disease of the eye and the third leading cause of blindness. Despite available treatment options, 67% of patients suffering from non-infectious uveitis reaching visual impairment and 22% are meeting a legal blindness criterion. The current treatment for active non-infectious anterior uveitis is topical steroids. Since their introduction to the eye 70 years ago, topical steroids have been used as first line treatment due to their potency in resolving inflammation. While potent in resolving inflammation, topical steroids carry a high risk of intraocular pressure (IOP) elevation mediated by steroids' receptors, and often if treatment is ceased without long tapering period, a recurrent rebound inflammation occurs. In some patients, IOP elevation leads to glaucoma (i.e., uveitic glaucoma). Uveitic glaucoma is a challenging disease to treat, with a unique pathophysiology, disease course, prognosis, and a significantly more difficult clinical course to manage than anterior uveitis without glaucoma. The overall prevalence of glaucoma in eyes with uveitis (i.e., uveitic glaucoma) varies from 10 to 20 percent but is much more common in chronic uveitis and can be as high as 46 percent. For more information, visit Contact: Investor Relations Tarsier Pharma [email protected] Photo - SOURCE Tarsier Pharma