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

• 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
• 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

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. !

项目总结/摘要 该第2阶段提案的目的是进一步开发一种新型、无毒的眼部防腐剂。玻璃体 注射疗法（IVT）是所有医学中最常进行的程序之一，大约 2016年在美国有600万次注射。为了患者的安全，需要进行眼部消毒，多项研究表明， 在没有接受眼表治疗的患者中， 在IVT之前进行灭菌。FDA批准的唯一眼用防腐剂是聚维酮碘5%（PI，品牌 名称：Betadine® 5%; Alcon，沃斯堡，TX）。PI在人体中导致显著的角膜上皮毒性， 使人衰弱的副作用，包括视力下降和IVT后持续3天以上的疼痛 为了解决Betadine的局限性，IRX-101已被开发为一种新型无毒防腐剂，用于 the eye.专有的作用机制避免了碘的使用，碘是PI中负责 眼毒性IRX-101的临床前测试已证明在30秒内几乎完全杀菌 与聚维酮碘的2分钟相比，此外，已发现IRX-101具有上级杀灭作用 耐甲氧西林金黄色葡萄球菌和表皮葡萄球菌，这是特别重要的，因为 这些耐药菌株的增加。最后，与PI形成鲜明对比的是，IRX-101已经证明了 在临床前兔研究中显著缺乏眼毒性。 在这项提案中，我们的目标是推进IRX-101进入人体临床试验。为了实现这一目标，我们打算 向FDA提交研究性新药申请，然后启动1/2期临床试验 研究两种IRX-101制剂的安全性。1/2期试验的结果将指导选择 最终IRX-101配方的最终版本，并允许我们启动我们的3期临床试验计划。如果成功，这 该项目将为FDA批准和商业化IRX-101奠定基础，IRX-101是一种有潜力的药物， 改变IVT在美国和世界各地患者的安全性和耐受性。 !