Novel, Non-Toxic Ocular Antiseptic For Intravitreal Injection Therapy

项目摘要/摘要 这一第二阶段提案的目标是进一步开发一种新型的、无毒的眼部防腐剂。玻璃体内 注射疗法(IVT)是所有医学中最常见的程序之一，大约有 2016年，美国有600万例注射。为了患者的安全，眼部消毒是必要的，多项研究已经 在没有接受眼表治疗的患者中显示出显著更高的盲眼感染率 IVT前的消毒。FDA批准的唯一眼部防腐剂是聚维酮碘5%(PI，品牌 名称：Betadine®5%；德克萨斯州沃斯堡阿尔康)。PI导致人类明显的角膜上皮毒性，导致 在衰弱的副作用中，包括视力下降和IVT后可持续3天以上的疼痛 为了解决倍他定的局限性，IRX-101已被开发为一种新型、无毒的防腐剂，用于 眼睛。专有的作用机制避免了碘的使用，碘是PI中负责 眼部毒性。IRX-101的临床前测试在30秒内显示出几乎完全的杀菌效果 与之相比，倍他定的暴露时间为2分钟。此外，IRX-101已被发现具有更好的杀伤力 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 这些耐药菌株的数量不断上升。最后，与PI形成鲜明对比的是，IRX-101展示了 在临床前兔研究中，明显缺乏眼部毒性。 在这项提案中，我们的目标是将IRX-101推进到人体临床试验中。为了实现这一目标，我们打算 向FDA提交研究新药申请，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 最终的IRX-101配方，并允许我们启动我们的第三阶段临床试验计划。如果成功，这将是 该项目将为FDA批准IRX-101并将其商业化奠定基础，IRX-101是一种具有 改变美国和世界各地患者接受IVT的安全性和耐受性。 好了！

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. !