January 30, 2023 Cranbury, New Jersey iVIEW Therapeutics Inc., a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics, today announced that the company completed a successful pre-IND meeting with FDA and received the agency’s full agreement on all CMC, non-clinical and clinical development plans to develop IVW-1001 for the treatment of sign and symptoms of dry eye disease (DED).The company is targeting to initiate phase I/II clinical trials for dry eye patients in the end of 2023.
Until recently, DED, also known as Dry Eye Syndrome (DES) and keratoconjunctivitis sicca (KCS) has been considered a multifactorial, progressive disorder of the ocular surface resulting from insufficient tear coverage of the cornea and conjunctiva accompanied by ocular surface inflammation. Global dry eye diseases market size is expected to reach US $8.21 billion by 2028 according to Business Wire. Currently available topical therapeutics for DED that target underlying pathophysiology generally do so through anti-inflammatory effects. However, these approaches deliver variable benefits since each drug impacts different steps in the inflammatory cascade, thus with limited fundamental therapeutic value. iVIEW Therapeutics is developing a new chemical entity (NCE), IVW-1001 to treat signs and symptoms of dry eye disease (DED). IVW-1001 is a TRPM8 receptor agonist which selectively activates TRPM8 receptors and their activation has the potential to reduce discomfort. Evidence from clinical studies showed that topical TRPM8 activation reduced eye discomfort and increased tear secretion in those with DED.
This successful Pre-IND meeting is a meaningful milestone for iVIEW that will advance IVW-1001 to the next stage of development” said George Ousler, Senior Vice President for Ora Inc., the premier ophthalmic development firm which aided in this achievement.
Dr. Bo Liang, Co-founder, Chairman and CEO of iVIEW Therapeutics Inc. commented: " We are very pleased to have the Agency’s full agreement on our plans to develop this novel compound. This shows confidence in our team and our preclinical and clinical plans to advance IVW-1001 to treat dry eye disease. We are on track for Phase I/II IND filing in 2023 and plan to initiate trials to dose dry eye patients directly in the first-in-human (FIH) clinical trials."
About iVIEW Therapeutics Inc.
iVIEW Therapeutics Inc. is a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics. We are driven by the pursuit of innovative science that leads to differentiated products to fulfill unmet medical needs. We invest in novel mechanisms of action, and differentiated drug delivery technology platforms that allow us to bring forward assets with potentially superior target product profiles. The company's innovative portfolio of small molecules and gene therapy assets cover dry eye, myopia, conjunctivitis, glaucoma, presbyopia。The company adheres to the vision: Bright Science, Clear Vision!
【美国东部时间2023年1月30日】总部位于美国新泽西州克兰伯里Cranbury的iVIEW Therapeutics公司，一家专注于创新眼科治疗的临床阶段生物技术公司，今天宣布已成功完成了与FDA的pre-IND会议，FDA全面同意公司提交的用于治疗干眼症症状和体征的IVW-1001的CMC/非临床/临床的开发计划。公司的目标是在2023年底开始进行针对干眼症患者的I/II期临床试验。
至今为止，DED（也称为干眼综合症（DES）和干燥性角膜结膜炎（KCS））一直被认为是一种多因素的、进行性的眼表疾病，其原因是角膜和结膜的泪液覆盖不足，并伴有眼表炎症。据美国商业资讯报道，预计到2028年，全球干眼症市场规模将达到82.1亿美元。目前可及的针对DED潜在病理生理学的局部治疗通常通过抗炎作用得以实现。然而，由于每种药物都会影响炎症级联反应的不同步骤，因此这些方法带来的疗效各不相同，这也造成了有限的基本治疗价值。IVIEW Therapeutics正在开发的这个全新小分子化学物（NCE）IVW-1001，直接改善DED的症状。IVW-1001是一种选择性激活TRPM8受体的TRPM8激动剂。来自在韩国完成的100例IIT临床研究的证据表明，TRPM8激活TRPM8受体，五分钟赋予病人凉爽感觉，一周后显著降低了DED患者的眼部不适感并增加了泪液分泌。
“此次Pre-IND会议的成功，将IVW-1001项目研发推进到更进一步的发展阶段，是iVIEW发展的一个重要里程碑。” 帮助公司此次PIND申报的美国专业眼科CRO开发公司Ora Inc.的高级副总裁George Ousler先生说道。
“此次Pre-IND会议的成功，将IVW-1001项目研发推进到更进一步的发展阶段，是iVIEW发展的一个重要里程碑。” 帮助公司此次PIND申报的美国专业眼科CRO开发公司Ora Inc.的高级副总裁George Ousler先生说道。
iVIEW Therapeutics公司联合创始人、董事长兼首席执行官Bo Liang梁波博士表示：” 我们非常高兴，FDA全部同意我们开发这个全新化合物的计划，这表明FDA对我们团队和我们推进的IVW-1001治疗干眼症的临床前/临床试验计划的信心和认可。我们正计划在2023年进行I期/II期IND申报，并计划在首次人体（FIH）临床试验中启动对干眼症患者给药的试验。”
关于 iVIEW Therapeutics Inc.
iVIEW Therapeutics公司是一家处于临床开发阶段的眼科创新药物研发公司。公司致力于追求带来差异化产品，填补未满足医学需求的创新科学专注于差异化的产品，以满足眼科临床的医疗需求。我们专注于开发新颖的作用机制和差异化的药物递送技术平台，拥有能够提供具有潜在商业差异化优势的产品管线。公司创新的小分子和基因治疗产品管线组合涵盖干眼症、近视眼、急性结膜炎、青光眼、老花眼等的创新治疗。
有关更多信息，请访问以下：
美国网站：www.iviewtherapeutics.com 电话：+1 609 773 8580
美国地址：5 CedarBrook Drive, Cranbury, NJ 08512 USA 新泽西州克兰伯里（近普林斯顿）
中国网站：www.iview-cn.com电话：+86 756 8826758
中国地址：中国广东省横琴粤澳深度合作区创意谷20栋D座二层
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