Visus Therapeutics, Inc.

LONDON & SEATTLE--( BUSINESS WIRE )--Tenpoint Therapeutics, Limited (“Tenpoint”) and Visus Therapeutics, Inc., (“Visus”) announce today the completion of their merger to create an entirely new chapter in ophthalmic therapeutic medicines aimed at rejuvenating the aging eye. The merger brings together a late-stage, potentially best-in-class, presbyopia-correcting eye drop, BRIMOCHOL™ PF, on track for NDA filing in 1H, 2025, with a promising pipeline of innovative therapeutics. The merger unites a strong syndicate of institutional investors who are committed to advancing BRIMOCHOL™ PF through marketing approval to patients worldwide while further advancing Tenpoint’s pipeline into clinical development. Tenpoint’s pipeline is comprised of three innovative programs aimed at rejuvenating the aging eye: BRIMOCHOL™ PF, a once-a-day, all day, presbyopia-correcting eye drop with a differentiated profile. BRIMOCHOL™ PF is a unique and patent-protected combination of carbachol, a potent miotic, and brimonidine, an alpha2-agonist. This combination enhances peak efficacy and extends duration; and through the vasoconstrictive properties of brimonidine, helps reduce ocular redness offering a potentially superior treatment for presbyopia. TPT-161, a novel small molecule designed to reverse cataract formation in aging adults. TPT-005, a cell therapy targeting RPE cell replacement for geographic atrophy. To support the continued development of these programs, Tenpoint will shortly embark on a Crossover financing round with insider participation to further fund the completion of clinical studies for BRIMOCHOL™ PF, and the commercialization preparations for a 1H, 2026 launch of BRIMOCHOL™ PF into the US market. As part of the leadership transition, Mr. Henric Bjarke has been appointed Chief Executive Officer of the newly merged company. “As we relaunch Tenpoint as a combined entity with Visus, we are excited to lead with a robust Ophthalmology pipeline, starting with BRIMOCHOL™ PF, a near-term therapeutic medicine for presbyopia alongside other innovative therapies to treat Cataract and Geographic Atrophy,” said Henric Bjarke, CEO. “With our combined teams, we have the right expertise to develop and successfully launch innovative products with the potential to be first and best in class in ophthalmic medicines.” Mr. Bjarke brings extensive commercial and operational leadership experience in the biopharmaceutical industry, with a focus on ophthalmology, hematology, and orphan diseases. He has held senior roles at several successful companies including, Inozyme Pharma, Ophthotech, Alexion Pharmaceuticals, (OSI) Eyetech, and Pharmacia. “The merger of Tenpoint and Visus is a pivotal moment in the evolution of both companies. As Board Chair, I am excited about the opportunity to collaborate with the new leadership team to commercialize BRIMOCHOL™ PF and advance innovative products into clinical development to meet unmet needs in ocular diseases,” said David Guyer, MD, Chairman of the Board. About Tenpoint Therapeutics Tenpoint Therapeutics Limited is a global, clinical-stage biotech company developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting treatments for ophthalmic indications with the greatest need and global market potential, including presbyopia, cataracts and geographic atrophy. Its lead asset, BRIMOCHOL™ PF, is a novel, pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia, a condition that afflicts approximately 2 billion people globally. BRIMOCHOL™ PF has completed its first Phase 3 pivotal trial (BRIO-I) and will complete the second pivotal study, BRIO-II, in 2025. This topical ophthalmic is poised for launch in 2026. Tenpoint’s leadership team includes ophthalmic industry luminaries with track records of successful approvals and commercialization of blockbuster drugs. A privately held company, Tenpoint Therapeutics is backed by AdBio Partners, British Patient Capital, Eight Roads, EQT Life Sciences, F-Prime Capital, Hillhouse Capital Management, Qiming Venture Partners USA, Sofinnova Partners, and UCL Technology Fund. To learn more visit tenpointtherapeutics.com and connect on LinkedIn .

The launch of emerging therapies, such as LNZ100 by Lenz Therapeutics, Phentolamine Ophthalmic Solution 0.75% by Viatris and Ocuphire Pharma, BRIMOCHOL PF (VT-1011) by Visus Therapeutics, among others will significantly impact the presbyopia market during the forecast period (2024–2034). LAS VEGAS, Nov. 14, 2024 /PRNewswire/ -- Presbyopia is an age-related refractive condition marked by a gradual decline in near vision, typically emerging between ages 40 and 60. It results from the lens losing elasticity and becoming thicker, harder, and less flexible due to structural protein changes. This impairs the lens's ability to adjust for near vision, reducing accommodative amplitude. Presbyopia can be classified into incipient, functional, absolute, premature, and nocturnal types, each representing different stages and manifestations of the condition. As per DelveInsight's assessment, the total prevalent cases of presbyopia in the 7MM were ~325 million in 2023. These cases are expected to increase at a significant CAGR of 1.1% during the forecast period i.e., 2024–2034. Based on severity, presbyopia was bifurcated into mild and moderate to severe presbyopia, in EU4 and the UK, moderate to severe presbyopia accounted for the maximum number of cases, which was approximately 95 million. Treatment options for presbyopia mainly consist of corrective lenses and surgical procedures. Non-invasive methods, such as reading glasses, bifocals, and progressive lenses, enhance vision at different distances. Contact lenses, including multifocal and monovision types, present another option. Surgical treatments like LASIK, conductive keratoplasty, and corneal inlays modify the eye's focusing capabilities. Recently, eye drops like pilocarpine hydrochloride have gained attention as a promising treatment, as they temporarily enhance near vision by constricting the pupil to improve depth of field. For non-drug treatments, reading glasses enable clear vision for tasks up close, while bifocals combine two prescriptions in a single lens to correct both distance and near vision. Progressive lenses provide a smooth transition between different vision zones with no visible lines. Contact lenses designed for presbyopia, like multifocal or accommodating lenses, offer greater convenience and a broader field of vision compared to glasses. For those looking for a more lasting solution, LASIK surgery can correct presbyopia by reshaping the cornea, although it tends to be more effective for younger individuals with stable vision needs. Conductive keratoplasty uses radiofrequency energy to enhance near vision by creating small spots on the cornea, serving as a non-invasive option. Corneal inlays involve inserting a tiny device into the cornea to enhance near vision while maintaining distance vision. Two FDA-approved treatments, VUITY and QLOSI, represent significant advancements in ophthalmology. Learn more about the FDA-approved presbyopia drugs @ Drugs for Presbyopia Treatment VUITY (1.25% pilocarpine HCl ophthalmic solution), developed by Allergan, is a groundbreaking treatment for presbyopia that received FDA approval in October 2021. This prescription eye drop functions by constricting the pupil, which improves near and intermediate vision while minimally impacting distance vision. Utilizing the miotic effects of pilocarpine, VUITY enhances focus for close-range activities, presenting a non-invasive alternative to reading glasses. Its approval represents a significant step forward in managing presbyopia, offering patients a convenient and effective solution to relieve the symptoms associated with the condition. QLOSI (0.4% pilocarpine hydrochloride ophthalmic solution), developed by Orasis Pharmaceuticals, is a new treatment for presbyopia that received approval from the US FDA in October 2023. This formulation utilizes pilocarpine, a cholinergic muscarinic agonist, to enhance the eye's ability to focus on nearby objects. The launch of QLOSI is expected in the latter half of 2024, providing patients with a non-surgical option for addressing age-related vision deterioration. To know more about presbyopia treatment options, visit @ New Treatment for Presbyopia The dynamics of the presbyopia treatment market are anticipated to change during the forecast period as companies across the 7MM are diligently working towards the development of novel treatment options to combat the existing treatment-based unmet needs. Key players, such as Viatris and Ocuphire Pharma (Phentolamine Ophthalmic Solution 0.75%), Visus Therapeutics (BRIMOCHOL PF), Lenz Therapeutics (LNZ100), and others are involved actively in developing potential treatment scopes. Discover which therapies are expected to grab major presbyopia market share @ Presbyopia Market Report LNZ100, developed by Lenz Therapeutics, is an experimental treatment for presbyopia that is currently progressing through Phase III clinical trials. This medication works by targeting and modulating the intraocular muscles to restore the eye's ability to focus on nearby objects, which is a common problem associated with aging. LNZ100 utilizes a unique mechanism of action that selectively modulates specific receptors in the eye to improve accommodation. Administered as eye drops, LNZ100 provides a non-invasive alternative to surgical treatments. The company intends to submit a New Drug Application (NDA) to the FDA in mid-2024, with plans for a market launch in the second half of 2025, establishing it as a significant therapeutic option for presbyopia management. BRIMOCHOL PF (VT-1011) is a drug under development by Visus Therapeutics aimed at treating presbyopia. This combination therapy includes carbachol and brimonidine tartrate and is designed to enhance near vision by utilizing its pharmacodynamic properties. Currently, BRIMOCHOL PF is in Phase III of clinical development. Following promising results from Phase II trials, it has advanced to this crucial stage, where the primary focus is to validate its therapeutic effects and detect any possible side effects before pursuing regulatory approval for market launch. The company plans to submit its New Drug Application (NDA) in the latter half of 2024, intending to provide a new treatment option for presbyopia. Phentolamine Ophthalmic Solution 0.75%, being developed by Viatris and Ocuphire Pharma, aims to treat presbyopia. This solution enhances near vision temporarily while maintaining distance vision, providing a non-surgical option to reading glasses or contact lenses. The development of Phentolamine Ophthalmic Solution 0.75% is in the final phases of clinical trials. It has successfully finished Phase II studies, which showed its efficacy and safety for the intended purpose. The product is currently in Phase III clinical trials to further verify its effectiveness and safety before pursuing regulatory approval. Discover more about drugs for presbyopia in development @ Presbyopia Clinical Trials The anticipated launch of these emerging therapies for presbyopia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the presbyopia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for presbyopia is expected to grow from USD ~17 billion in 2023 with a CAGR of 3.2% by 2034. The anticipated increase in market size is driven by advancements in treatment options, greater healthcare access, and a rising incidence of the condition, which together foster a higher demand for innovative and effective therapies. DelveInsight's latest published market report titled as Presbyopia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the presbyopia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The presbyopia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Presbyopia Total Diagnosed Prevalent Cases of Presbyopia Gender-specific Diagnosed Prevalent Cases of Presbyopia Age-specific Diagnosed Prevalent Cases of Presbyopia Severity-specific Diagnosed Prevalent Cases of Presbyopia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM presbyopia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this presbyopia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the presbyopia market. Also, stay abreast of the mitigating factors to improve your market position in the presbyopia therapeutic space. Related Reports Presbyopia Pipeline Presbyopia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key presbyopia companies, including Orasis Pharmaceuticals, Novartis, Cellix Bio, Visus Therapeutics, AbbVie, Vyluma, Lenz Therapeutics, Ocuphire Pharma, JIXING Pharmaceuticals, Eyenovia, among others. Myopia Market Myopia Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key myopia companies such as Vyluma, Inc., Sydnexis, Inc., Ocumension limited, Santen Pharmaceutical, Cloudbreak therapeutics, Nevakar, Inc., Eyenovia, Stuart Therapeutics, Cellix Bio, JeniVision, Zhaoke Ophthalmology, among others. Myopia Pipeline Myopia Pipeline Insight – 2024 report provides comprehensive insights into pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myopia companies involved, such as Vyluma, Inc., Sydnexis, Inc., Ocumension limited, Santen Pharmaceutical, Cloudbreak therapeutics, Nevakar, Inc., Eyenovia, Stuart Therapeutics, Cellix Bio, JeniVision, Zhaoke Ophthalmology, among others. Myopia Progression Market Myopia Progression Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key myopia progression companies such as Johnson & Johnson Vision Care Inc, Beijing Airdoc Technology Co., Ltd, Essilor International, Menicon Co., Ltd., SightGlass Vision Inc, Indizen Optical Technologies, S.L.U., Bausch & Lomb Incorporated, Coopervision Inc, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎药明康德内容团队编辑 LENZ Therapeutics今天宣布，美国FDA已接受其醋克立定（1.75% aceclidine）眼药水配方LNZ100用于治疗老花眼的新药申请（NDA）。根据之前所公布的3期试验结果，在不影响患者远视力（distance vision）的情形下，患者的近视力（near vision）可在使用LNZ100眼药水后30分钟内达成显著的改善，且疗效可维持10个小时！这表示患者只要在早上滴几滴眼药水，几乎整个白天的近视力都得到提高！该申请的PDUFA的目标日期为2025年8月8日。 老花眼是随着年龄的增长而出现的常见视力衰退，影响全球近20亿人。我们眼睛中的晶状体像是照相机中调节焦距的镜片，改变它的形状可以将图像聚焦在视网膜上，让我们清晰地看到外面的世界。然而，随着年龄的增长，我们眼睛中晶状体的弹性变差，控制晶状体形状的睫状体肌肉的收缩能力也逐渐下降，这些综合因素让晶状体的聚焦能力随之下降，这让近处的图像难以聚焦在视网膜上。老花眼通常在40岁之后出现，目前大多数治疗方法是佩戴老花镜，但是对很多人来说并不方便。 目前开发的老花眼药物疗法大多数采用的策略是缩小瞳孔。缩小瞳孔产生的针孔效应（pinhole effect）可以增加景深，让穿过瞳孔的光能够聚焦在视网膜上。 ▲缩小瞳孔改善老花眼患者视力的科学基础（图片来源：参考资料[3]） 这次NDA的提交主要基于关键3期CLARITY试验积极数据的支持。CLARITY是一项LNZ100和LNZ101治疗老花眼的3期多中心、双盲、随机的疗效和安全性研究。它由两项为期六周的疗效试验CLARITY 1和2以及一项为期六个月的安全性试验CLARITY 3组成。 分析显示，LNZ100达成试验主要终点和关键次要终点，即在近视力测量上，表现出视力表上3行（15个字母）以上的阅读改善，同时并不失去1行（5个字母）的远视力。在溶剂对照的CLARITY 2试验中，试验第1天结果显示LNZ100展现以下效果： ▲LNZ100达成试验主要终点（图片来源：参考资料[2]） 快速起效：71%患者在30分钟内实现视力表上三行或更大的改善（p<0.0001）。 达主要终点：71%的患者在3小时内取得视力表上三行或更多的改善（p<0.0001）。 持续时间长：40％的患者在10小时内实现了视力表上三行或更多的改善（p<0.0001）。 在为期四周的研究期间，CLARITY 1和2试验中所显示患者的近视力改善具有可重复性与一致性。 LNZ100耐受性良好，在三项CLARITY试验中未观察到严重的治疗相关不良事件。 ▲LNZ100展现良好的耐受性（图片来源：参考资料[2]） LNZ100是一种不含防腐剂、每日使用一次的眼药水，其中主要有效成分为醋克利定。醋克立定是一种小分子乙酰胆碱受体激动剂，可引起瞳孔收缩，产生针孔效应，从而改善近视力。但与其它胆碱受体激动剂相比，它对控制瞳孔大小的虹膜肌肉的作用更具有特异性，从而在缩小瞳孔的同时减少睫状体肌肉的收缩，降低晶状体的屈光变化，进而避免影响患者的远视力。 图片来源：123RF 近年来多家医药公司投入治疗老花眼的眼药水疗法开发。艾伯维（AbbVie）旗下艾尔建（Allergan）公司的Vuity（1.25%毛果芸香碱滴眼液）在2021年10月获得美国FDA批准用于治疗老花眼。毛果芸香碱是一种成熟的眼部护理治疗药物，它的主要作用机制是收缩瞳孔，从而增强景深，改善近视力和中距视力。试验结果显示，与安慰剂相比，接受Vuity治疗的患者检验近视力的指标获得显著改善，同时这一眼药水不会影响患者的远视力。它最快在滴入15分钟后生效，疗效可持续6个小时。新闻稿指出，这是FDA批准的首款用于治疗老花眼的眼药水疗法。去年10月，Orasis Pharmaceuticals所开发的Qlosi（0.4%毛果芸香碱滴眼液）获得FDA批准上市，用于治疗成人老花眼。受试者最早在接受治疗20分钟后就可获得视力改善，并且疗效可持续长达8个小时。而由Eyenovia开发，同样以毛果芸香碱为主要配方的MicroLine眼药水也在3期临床试验当中获得积极结果，上市申请正在准备中。MicroLine的给药方式与众不同。传统的给药方式是用药瓶滴眼药水，一滴药水的体积大约是40微升。而MicroLine配方使用一种喷雾器的方式向眼睛里喷出细小的毛果芸香碱液滴，这种给药方式每次只递送大约8微升的药物。降低给药剂量可以减少和药物或药水中防腐剂相关的副作用。 而由Visus Therapeutics公司所开发的Brimochol PF也在去年4月于3期试验当中获得积极结果。Brimochol PF包含了固定剂量的卡巴胆碱（carbachol）和溴莫尼定（brimonidine）两种获批药物。与其成分中的卡巴胆碱或溴莫尼定单药相比，该疗法在多个时间点均显著改善患者的近、远视力，并且瞳孔收缩效果可长达10小时。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia. Retrieved October 22, 2024 from https://www.globenewswire.com/news-release/2024/10/21/2966144/0/en/LENZ-Therapeutics-Announces-FDA-Acceptance-of-New-Drug-Application-for-LNZ100-for-the-Treatment-of-Presbyopia.html [2] Topline CLARITY Results. Retrieved April 3, 2024 https://d1io3yog0oux5.cloudfront.net/_1b75a0055e0f2e21ec4f05c07a9d694b/lenztx/db/2266/21446/presentation/Clarity+Topline+Presentation+Slides+04022024+final+locked.pdf [3] LENZ Therapeutics Corporate Presentation. Retrieved November 1, 2021, from https://lenz-tx.com/wp-content/uploads/2021/10/LENZ_corporate_presentation_for_website.pdf [4] Eyenovia Reports First Quarter 2023 Financial Results and Provides Business Update. Retrieved October 22, 2024 from https://www.sec.gov/Archives/edgar/data/1682639/000110465923059164/tm2315261d1_ex99-1.htm 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新