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.

项目概要/摘要 第二阶段提案的目标是进一步开发一种新型无毒眼部消毒剂。玻璃体内 注射疗法 (IVT) 是所有医学中最常进行的手术之一，大约有 2016 年美国注射了 600 万次。为了患者安全，需要进行眼部消毒，多项研究表明 结果显示，未接受眼表治疗的患者致盲性眼部感染的发生率显着升高 IVT 前绝育。唯一经 FDA 批准的眼用消毒剂是聚维酮碘 5%（PI，品牌 名称：Betadine® 5%；爱尔康，沃斯堡，德克萨斯州）。 PI 会导致人类显着的角膜上皮毒性，从而导致 导致衰弱的副作用，包括视力下降和 IVT 后持续超过 3 天的疼痛 为了解决 Betadine 的局限性，IRX-101 被开发为一种新型无毒防腐剂，用于 眼睛。专有的作用机制避免使用碘，碘是 PI 中的活性剂，负责 眼毒性。 IRX-101的临床前测试显示30秒内接近完全的杀菌效果 与 Betadine 的 2 分钟暴露时间相比。此外，IRX-101被发现具有优越的杀伤力 耐甲氧西林金黄色葡萄球菌和表皮葡萄球菌，鉴于 这些耐药菌株的增加。最后，与 PI 形成鲜明对比的是，IRX-101 展示了 临床前兔子研究中明显缺乏眼部毒性。 在该提案中，我们的目标是将 IRX-101 推进人体临床试验。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 IRX-101 两种配方的安全性。 1/2期试验的结果将指导选择 最终的 IRX-101 配方，使我们能够启动我们的 3 期临床试验计划。如果成功的话，这 该项目将为 IRX-101 的 FDA 批准和商业化奠定基础，IRX-101 是一种有潜力的药物 改变美国和世界各地患者 IVT 的安全性和耐受性。