Novel, Non-Toxic Ocular Antiseptic For Intravitreal Injection Therapy

用于玻璃体内注射治疗的新型无毒眼部消毒剂

基本信息

批准号：
9909201
负责人：
Thomas W Chalberg
金额：
$ 84.8万
依托单位：
IRENIX MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-01 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9909201
关键词：
Address Adverse effects Affect Aftercare Analgesics Anesthesia procedures Antisepsis Authorization documentation Blindness Clinical Clinical Data Clinical Trials Clinical trial protocol document Consumption Contralateral Cornea Cutaneous Data Diabetes Mellitus Dose Endophthalmitis Enrollment Eye Eye Infections FDA approved Formulation Funding Goals Gram-Positive Bacteria Grant Human Image Injection of therapeutic agent Injections Investigational Drugs Investigational New Drug Application Iodine Local Anti-Infective Agents Macular degeneration Masks Measures Medical Medicine Methods Names National Eye Institute Obesity Ophthalmology Oral Oryctolagus cuniculus Outcome Oxides Oxygen Pain Pain management Patient Care Patients Pharmaceutical Preparations Phase Phase I/II Clinical Trial Phase I/II Trial Phase III Clinical Trials Povidone-Iodine Preclinical Testing Procedures Process Randomized Reader Recurrence Retinal Diseases Retinal Vein Occlusion Safety Small Business Innovation Research Grant Stains Staphylococcus epidermidis Sterilization Technology Testing Time Toxic effect United States Vision Visual Visual Acuity aging population antimicrobial arm bacterial resistance bactericide base bevacizumab commercialization compliance behavior corneal epithelium diabetic efficacy evaluation experience human subject improved intravitreal injection macular edema methicillin resistant Staphylococcus aureus novel novel therapeutics ocular surface patient safety pre-clinical prevent primary endpoint primary outcome programs randomized controlled study research clinical testing secondary endpoint side effect slit lamp imaging

项目摘要

PROJECT SUMMARY / ABSTRACT The objective of this Phase 2 proposal is to further develop a novel, non-toxic ocular antiseptic. Intravitreal injection therapy (IVT) is one of the most commonly performed procedures in all of medicine, with approximately 6 million injections in the USA in 2016. Ocular antisepsis is required for patient safety, and multiple studies have shown dramatically higher rates of blinding eye infections in patients who did not receive ocular surface sterilization prior to IVT. The only FDA-approved antiseptic for ocular use is Povidone-Iodine 5% (PI, brand name: Betadine® 5%; Alcon, Fort Worth, TX). PI leads to marked corneal epithelial toxicity in humans, resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-IVT To address the limitations of Betadine, IRX-101 has been developed as a novel, non-toxic antiseptic for use on the eye. The proprietary mechanism of action avoids the use of iodine, the active agent in PI responsible for ocular toxicity. Pre-clinical testing of IRX-101 has demonstrated near-complete bactericidal effect in 30 seconds of exposure time compared to 2 minutes for Betadine. In addition, IRX-101 has been found to have superior kill of methicillin resistant staphylococcus aureus and epidermidis, which is of particular importance given the increasing rise of these resistant bacterial strains. Finally, in stark contrast to PI, IRX-101 has demonstrated a remarkable lack of ocular toxicity in preclinical rabbit studies. In this proposal, we aim to advance IRX-101 into human clinical trials. To accomplish this goal, we intend to submit an Investigational New Drug application with FDA, followed by initiation of a Phase 1/2 clinical trial investigating the safety of two formulations of IRX-101. The results of the Phase 1/2 trial will guide the selection of the final IRX-101 formulation and allow us to launch our Phase 3 clinical trial program. If successful, this project will lay the groundwork for FDA approval and commercialization of IRX-101, a drug with the potential to transform the safety and tolerability of IVT for patients in the USA and around the world. !

项目摘要 /摘要该阶段2提案的目的是进一步发展出一种新型的无毒眼杀性。玻璃体内注射疗法（IVT）是所有医学中最常见的手术之一，大约 2016年在美国进行了600万次注射。患者安全需要眼部反曲，多项研究具有在未接受眼表面的患者中显示出较高的盲目眼感染率 IVT之前的灭菌。唯一用于眼部使用的FDA批准的防腐剂是Povidone-iodine 5％（PI，Brand 名称：betadine®5％；德克萨斯州沃思堡的Alcon）。 PI导致人类角膜上皮毒性明显在使副作用令人衰弱的过程中，包括敏锐度和疼痛的降低，可以持续3天以上为了解决Betadine的局限性，IRX-101已被开发为一种新型的无毒防腐剂，可用于眼睛。行动的专有机制避免使用碘，PI中的活性剂负责眼毒性。 IRX-101的临床前测试已显示出30秒内接近完整的细菌作用曝光时间为betadine 2分钟。此外，已经发现IRX-101具有优越的杀戮甲氧西林金黄色葡萄球菌和表皮的抗甲氧西林的，这一点尤其重要这些抗性细菌菌株的增加。最后，与PI形成鲜明对比的是，IRX-101证明了一个临床前兔研究中明显缺乏眼毒性。在此提案中，我们旨在将IRX-101推进到人类的临床试验中。为了实现这一目标，我们打算通过FDA提交研究性新药应用，然后开始进行1/2期临床试验研究IRX-101的两个公式的安全性。第1/2阶段试验的结果将指导选择最终的IRX-101公式，使我们能够启动3阶段临床试验计划。如果成功，这项目将为FDA批准和商业化的IRX-101奠定基础，IRX-101有可能改变了美国和世界各地患者的IVT的安全性和耐受性。呢