Retinal Neovascularization

SEATTLE--(BUSINESS WIRE)-- Kubota Vision Inc. (“Kubota Vision” or the “Company”), a clinical-stage specialty ophthalmology company and a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), announced today the execution of a collaborative research agreement between Kubota Vision and China Medical University Hsinchu Hospital, Department of Ophthalmology, for a study using Kubota Glass in Taiwan, led by Dr. Ying-Shan Chen. The prospective study will evaluate the effectiveness of Kubota Glass technology in myopic children as compared with a 0.01% low-dose atropine control group, including an arm which will evaluate the potential for a synergistic effect with combination therapy. Dr. Chen is a globally renowned leader in myopia research and treatment, serving as the chief of Ophthalmology at China Medical University Hsinchu Hospital. Dr. Chen stated, “Progressive myopia poses a heavy burden to individuals and society as a whole. I am always seeking new and effective ways to treat progressive myopic patients, so I am excited to work with Kubota Vision to evaluate Kubota Glass technology.” Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc., stated, “As recent studies have shown limited effectiveness in some patient populations with 0.01% atropine monotherapy1,2, the use of combination treatments for slowing the progression of myopia has been suggested as a next step for evaluating optical strategies such specialized glasses3. We are excited to explore this important area with Dr. Chen, who is one of the foremost experts in myopia treatment, as we continue to work toward our goal of revolutionizing myopia therapy around the world.” Zadnik K, Schulman E, Flitcroft I, et al. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jun 1:e232097. Repka MX, Weise KK, Chandler DL, et al. Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. Published online July 13, 2023. About Kubota Glass™ Technology Kubota Glass technology works to aid vision in myopia by projecting specially focused images generated using micro-LEDS in the peripheral visual field. The Company has been conducting and publishing research evaluating the device for the management of myopia. Kubota Glasses technology leverages nanotechnology in its electronic glasses-based illumination device and seeks to help manage myopia by providing specially focused illumination while maintaining high-quality central vision. About Kubota Vision Inc. Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Tokyo 4596), committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota Glass technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients. ; Cautionary Statements: “Kubota Vision,” the Kubota Vision logo, and “Kubota” are registered trademarks or trademarks of Kubota Vision Inc. or Kubota Pharmaceutical Holdings in various jurisdictions. View source version on businesswire.com: Contacts Media and Investor Relations Contact: Keiko Yoshino Phone: +81-3-6550-8928 Email: pr@kubotaholdings.co.jp Source: Kubota Vision Inc. View this news release online at:

Mylight study met its primary efficacy endpoint and showed no clinically meaningful differences to reference aflibercept Results offer hope of new affordable option for patients with nAMD, a leading cause of visual impairment and progressive vision loss for older adults1 Aflibercept is one of four high-value biosimilars that Sandoz plans to launch over next few years, further expanding patient access to high-quality biologics Sandoz, a global leader in off-patent medicines, today releases positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need. Mylight (ClinicalTrials.gov NCT04864834) is part of a comprehensive biosimilar development program that encompasses analytical, preclinical, and a clinical study. The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. Safety, immunogenicity, and pharmacokinetics results further confirm that there is no clinically meaningful difference between the products. The reference product Eylea® is indicated to improve and subsequently maintain visual acuity in patients with Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema, macular edema secondary to Retinal Vein Occlusion (RVO), and other specific neovascular retinal diseases. 2 These conditions cause blurring of central vision and, if untreated, can lead to permanent vision loss. nAMD affects over 200 million people worldwide and is one of the most widespread causes of blindness.3 Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “This important milestone, confirming therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology. It also underscores our ability to provide high-quality, affordable biologics to individuals to help the treatment of their disease, and highlights the rich Sandoz pipeline of biologics.” Sandoz is committed to helping millions of patients by providing affordable access to critical and potentially life-changing biologic medicines across a wide range of therapeutic areas including ophthalmology, immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 24 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has demonstrated that biosimilars can significantly expand patient access to highly effective and safe medicines while increasing healthcare savings and creating competition that fuels innovation and development of new and enhanced treatments in areas of unmet need. About aflibercept Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular retinal diseases, like neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression. About Mylight Mylight is a randomized, double-masked, parallel 2-arm study, which enrolled 485 patients across 16 countries. The Mylight study was conducted in nAMD (wet/exudative) as this is an adequately sensitive indication to demonstrate therapeutic equivalence to the reference biologic, Eylea®.2 Neovascular AMD patients were randomized 1:1 to receive either biosimilar aflibercept or Eylea® for 48 weeks followed by a safety follow-up period of four weeks. The total study duration was 52 weeks. The primary endpoint is the mean change in best corrected visual acuity (BCVA) score from baseline to week 8, using a standard test chart (EDTRS). The global development program for Sandoz biosimilar aflibercept was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory submissions. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our vision is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines covers major therapeutic areas. References National Eye Institute. Age-Related Macular Degeneration (AMD). Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration. Last accessed: July 2023. European Medicines Agency (EMA). Summary of Product Characteristics (SmPC) for Eylea (aflibercept). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/eylea. Last accessed: July 2023. Vyawahare H, and Pranaykumar S. Age-Related Macular Degeneration: Epidemiology, Pathophysiology, Diagnosis, and Treatment. Cureus. 2020;14(9):e29583. Last accessed: August 2023. The content above comes from the network. if any infringement, please contact us to modify.

Perceptive Advisors leads round to execute study in patients with wet age-related macular degeneration (wet AMD)BALTIMORE, July 26, 2023 (GLOBE NEWSWIRE) -- AsclepiX Therapeutics, Inc., a clinical-stage biotech company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, announced today that it has secured a $10 million Series A-3 financing. The round was led by Perceptive Advisors with participation from the existing investors Hibiscus Capital Management Fund II and Rapha Capital Management and its managed fund, Rapha Capital PE Life Sciences Fund VI, in addition to a new outside investor. “With the completion of this round, we are excited to embark into the next phase of our clinical development program,” said Dr. Amir Shojaei, Chief Scientific Officer and Executive Vice President, Clinical Development. “The DISCOVER study, utilizing AXT107 microparticulate suspension, will evaluate the safety and tolerability of three doses of AXT107 in patients with wet AMD. We look forward to announcing the initiation of enrollment in early 2024.” The lead clinical candidate, integrin regulating peptide AXT107 (gersizangitide), has a novel mechanism of action that inhibits neovascularization, reduces vascular permeability, and suppresses vascular inflammation. As presented in a microparticulate suspension, AXT107 may be capable of maintaining sustained biological activity with one injection well beyond current standard of care. “Despite the challenging investment climate, the successful raise is a testament to the technology,” said Chris Garabedian, Board Director. “We have great confidence in the AsclepiX leadership team, the potential of AXT107 as a novel approach to treat neovascular retinal diseases, and the financial return on our investment.” About AXT107 AXT107 inhibits pro-angiogenic vascular endothelial growth factor receptor 2 (VEGFR2) and activates the vessel stabilizing receptor tyrosine kinase (Tie2), the two validated pathways for the treatment of retinal vascular diseases. Both pathways are mediated by the interaction of AXT107 with integrin αvβ3 and integrin α5β1. AXT107 is presented as a microparticulate suspension suitable for intraocular injection. The Tie2 effects of AXT107 complement those of the anti-VEGF action, potentially offering greater improvement in vision gains as well as reduction of vascular permeability and suppression of inflammation. Due to its inherent low aqueous solubility, AXT107 administered intraocularly can potentially provide substantial durability, which could dramatically reduce the treatment burden associated with current standard of care. The intraocular injection of AXT107 microparticulate suspension will be explored in the DISCOVER study, an open label, single injection, dose escalating, 40-week, phase 1/2a clinical study in patients with wet AMD aiming to evaluate safety, tolerability, bioactivity and duration of action across three dose levels of AXT107. About AsclepiX Therapeutics, Inc. AsclepiX Therapeutics, Inc. is a clinical stage biopharmaceutical company using computational biology to identify potent peptide regulators of vascular homeostasis with the lead candidate, AXT107, in retinal diseases. AsclepiX was founded by Johns Hopkins University School of Medicine researchers, initially licensing their groundbreaking portfolio of vascular homeostatic peptides and technologies. For more information, please visit: www.asclepix.com. AsclepiX Media Contact:Christie Markowitzcmarkowitz@asclepix.com Source: AsclepiX Therapeutics, Inc.