Visus Therapeutics Announces FDA Acceptance of IND for Presbyopia-Correcting Eye Drop

Visus Therapeutics宣布FDA接受IND用于老花眼矫正滴眼液

2021-03-16 21:30:07 BioSpace

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Acceptance Clears Path for Initiation of Phase 2 Clinical Trial for BRIMOCHOL SEATTLE--(BUSINESS WIRE)-- Visus Therapeutics Inc. (the “Company”), a clinical-stage pharmaceutical company in pursuit of developing the world’s first presbyopia-correcting eye drop with the potential to last a minimum of eight hours, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) to proceed with the clinical development program for BRIMOCHOL™, the company’s lead investigational asset. BRIMOCHOL, a proprietary combination of carbachol and brimonidine tartrate, is designed to be a once-daily eye drop to correct for the loss of near vision associated with presbyopia. Under this IND, Visus will initiate its planned Phase 2 clinical trial in the U.S. immediately. “The FDA’s acceptance of the IND for BRIMOCHOL represents an important step forward for Visus Therapeutics and, more importantly, for the estimated 123 million U.S. adults living with presbyopia,” said Ben Bergo, co-founder and chief executive officer of Visus. “We are excited to begin dosing patients in the Phase 2 clinical study, which we believe will validate BRIMOCHOL as a well-tolerated solution that meets patients’ desire for a long-lasting near vision treatment option.” Six clinical studies have been conducted in more than 200 patients evaluating the safety and efficacy of BRIMOCHOL.1 These studies demonstrated an average near visual acuity improvement of five lines or more on the Jaeger eye chart, with a duration of a minimum of eight hours post-dose.2 The most recent study, published in 2019 in the International Journal of Ophthalmic Research, evaluated 57 patients and reported that BRIMOCHOL’s proprietary combination of carbachol and brimonidine delivered sustained improvement in near visual acuity for a minimum of eight hours.2 It also showed an average improvement of more than five lines on the Jaeger eye chart and no reports of brow ache or loss in distance vision. Visus has confirmed a 505(b)(2) pathway with the FDA. About BRIMOCHOL BRIMOCHOL is an investigational drug designed to be a once-daily eye drop to correct for the loss of near vision associated with presbyopia. BRIMOCHOL is a combination eye drop with a proprietary and patent-protected formulation that combines carbachol (a cholinergic miotic agent) and brimonidine tartrate (an alpha-2 agonist), two well-studied and FDA-approved medicines. Carbachol produces a “pinhole effect”, which reduces the size of the pupil and allows the light rays focused on the retina to enter the eye, thereby sharpening images. The addition of brimonidine to carbachol is designed to provide several benefits, including longer duration of the pinhole effect and a lower incidence of the side effects typically induced by miotic agents. About Presbyopia Presbyopia is the loss of near vision associated with aging, making it difficult to perform tasks like reading fine print. It typically begins when adults are in their 40s and becomes almost universal by age 50.3 Presbyopia impacts billions of people globally with approximately 123 million adults affected in the U.S. alone.4 Reading glasses are the most common solution for near-vision correction. However, many people find glasses inconvenient and/or prefer not to wear them for aesthetic reasons. Currently, there are no FDA-approved medications for presbyopia. About Visus Therapeutics Visus Therapeutics is a clinical-stage company in pursuit of developing the world’s first presbyopia-correcting eye drop with the potential to last a minimum of eight hours. With offices in Seattle and Orange County, Calif., its lead clinical candidate is BRIMOCHOL, an eye drop designed to correct the loss of near vision associated with presbyopia. In parallel, Visus Therapeutics is focused on advancing its pipeline of early-stage ophthalmic product candidates. For more information, visit: www.visustx.com and follow us on Twitter (@VisusTx) and on LinkedIn. 1 Data on file. 2 Abdelkader Int. J. Ophthalmic Res 2019 September; 5(1): 317-320. 3 US Census data, www.census.gov, accessed 7 September, 2019. 4 Market Scope, Global Presbyopia-Correcting Surgery Market Report, April 2012. View source version on businesswire.com: https://www.businesswire.com/news/home/20210316005220/en/ Eye Care Trade Press: Michele Gray Michele_gray@me.com (917) 449-9250 Business & Biotech Press: Sierra Smith sierra@healthandcommerce.com (408) 540-4296 Source: Visus Therapeutics Inc. View this news release online at: http://www.businesswire.com/news/home/20210316005220/en
验收为启动溴氨酚2期临床试验扫清了道路 Visus Therapeutics Inc.(以下简称“公司”)是一家临床阶段制药公司,致力于开发世界上首款具有至少八小时使用潜力的老花眼矫正眼药水。今天,美国食品和药物管理局(FDA)已接受该公司的研究性新药申请(IND),以继续开展该公司的主要研究资产----™苯磺酰胺的临床开发项目,该公司的研究性资产是Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol Brimochol。BRIMOCHOL是卡巴胆碱和酒石酸溴莫尼定的专利组合,是一种每日一次的滴眼液,用于矫正与老花眼相关的近视力丧失。根据这一IND,Visus将立即在美国启动计划中的2期临床试验。 Visus联合创始人兼首席执行官Ben Bergo说:“FDA接受BRIMOCHOL的IND标志着Visus治疗公司向前迈出了重要的一步,更重要的是,对于估计有1.23亿美国老花眼的成年人来说。”“我们很高兴能在2期临床研究中开始给患者给药,我们相信这将验证BRIMOCHOL是一种耐受性良好的解决方案,满足患者对长期近视力治疗选择的愿望。” 在200多名患者中进行了6项临床研究,评估了Brimochol1的安全性和有效性。这些研究表明,在耶格视力表上,平均近视力提高了5行或更多,2最近的一项研究于2019年发表在《国际眼科研究杂志》上,对57名患者进行了评估,报告称,Brimochol的专有卡巴胆碱和溴莫尼定的组合在至少8小时内可持续改善近视力。2该研究还显示,耶格视力表平均改善超过5行,没有眉毛酸痛或远视力下降的报告。Visus已经与FDA确认了505(b)(2)途径。 关于BRIMOCHOL BRIMOCHOL是一种研究性药物,设计为每日一次的滴眼液,用于矫正与老花眼相关的近视力丧失。BRIMOCHOL是一种联合滴眼液,具有专利保护的配方,将卡巴胆碱(一种胆碱能缩宫剂)和酒石酸溴莫尼定(一种alpha-2激动剂)结合在一起,这两种药物是经过充分研究和FDA批准的。卡巴胆碱产生“针孔效应”,缩小瞳孔大小,让聚焦在视网膜上的光线进入眼睛,从而锐化图像。在卡巴胆碱中加入溴莫尼定的目的是提供几个好处,包括针孔效应的持续时间更长,减少缩瞳剂引起的副作用的发生率。 关于老花眼 老花眼是与衰老相关的近视力丧失,使其难以完成阅读小字等任务。老花眼通常从40多岁开始,到50多岁几乎普及。老花眼影响全球数十亿人,仅美国就有大约1.23亿成年人受影响。4老花镜是近视力矫正的最常见的解决方案。然而,许多人觉得眼镜不方便和/或出于美观的原因宁愿不戴眼镜。目前,没有FDA批准的老花眼药物。 关于Visus治疗学 Visus Therapeutics是一家处于临床阶段的公司,致力于开发世界上第一种有可能维持至少8小时的老花眼矫正眼药水。该公司在西雅图和加利福尼亚州奥兰治县设有办事处,其主要临床候选药物是BRIMOCHOL,一种用于矫正老花眼引起的近视力丧失的眼药水。同时,Visus Therapeutics专注于推进其早期眼科候选产品的管道。欲了解更多信息,请访问:www.visustx.com,并在Twitter(@visustx)和LinkedIn上关注我们。 文件中有1个数据。 2 Abdelkader Int.J.眼科研究,2019年9月;5(1):317-320。 3美国人口普查数据,www.Census.gov,2019年9月7日查阅。 4市场范围,《全球老花眼矫正手术市场报告》,2012年4月。 在businesswire.com上查看源版本:https://www.businesswire.com/news/home/20210316005220/en/ 眼保健行业出版社: 米歇尔·格雷 michele_gray@me.com (917)449-9250 商业与生物技术出版社: 谢拉·史密斯 电子邮件:sierra@healthandcommerce.com (408)540-4296 资料来源:Visus Therapeutics Inc. 请在以下网址联机查看此新闻稿: http://www.businesswire.com/news/home/20210316005220/en

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