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: 10647916
• 负责人: Thomas W Chalberg
• 金额: $ 22.31万
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10647916
• 关键词: Address; Affect; Antisepsis; Clinical Trials; Cornea; Data; Eye; Eye Infections; FDA approved; Formulation; Goals; Human; Injection of therapeutic agent; Injections; Investigational New Drug Application; Iodine; Local Anti-Infective Agents; Medicine; Names; Oryctolagus cuniculus; Outcome; Pain; Patients; Pharmaceutical Preparations; Phase; Phase I/II Clinical Trial; Phase I/II Trial; Phase III Clinical Trials; Povidone-Iodine; Preclinical Testing; Procedures; Safety; Staphylococcus epidermidis; Sterilization; Time; Toxic effect; Vision; Visual Acuity; antimicrobial; bacterial resistance; bactericide; commercialization; corneal epithelium; improved; intravitreal injection; methicillin resistant Staphylococcus aureus; novel; ocular surface; patient safety; pre-clinical; programs; research clinical testing; side effect

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。