Latanoprost

Publication in the Journal of Ocular Pharmacology and Therapeutics highlights the ability of the Optejet to achieve a therapeutic dose of medication with far less exposure to harmful preservatives Additional presentation at the American Academy of Optometry summarizes a Phase 4 study of Mydcombi demonstrating that clinically relevant mydriasis can be achieved with a half-dose per eye NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a publication in the Journal of Ocular Pharmacology and Therapeutics as well as an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis” Annual Meeting. Publication in the Journal of Ocular Pharmacology and Therapeutics The peer-reviewed paper highlights the ability of Eyenovia’s proprietary Optejet dispenser to deliver a therapeutic dose of latanoprost with far less exposure to the preservative benzalkonium chloride (BAK) than traditional eye drops. BAK, in larger volumes, can cause unwanted side effects, including cytotoxicity, cytoplasmic shrinkage, and loss of cell-cell contact, and expression of chemokine (C-C motif) ligand 2 and interleukin-6 (markers of inflammation). In contrast, this in-vitro study of latanoprost plus BAK delivered in the same amount by the Optejet dispenser (8 microliters) avoided the cytotoxicity associated with larger volumes found in eye drops and was similar to no treatment controls and BAK-free latanoprost drops. “We have shown in prior studies the ability of the Optejet dispenser to achieve a therapeutic dose of medication with approximately 80% less volume and exposure to harmful preservatives than traditional eye drops,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The implication here is that preserved medications may not need to be reformulated to get many of the benefits of non-preserved products if delivered with the Optejet. We believe this creates potential opportunities for the Optejet to improve the administration of topical ocular therapeutics well beyond our own development pipeline.” Presentation at the American Academy of Optometry’s “Academy 2024” Eyenovia also announced today an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis,” which is being held November 6-9, in Indianapolis, IN. The presentation details the results of an open-label Phase 4 study of 1% tropicamide and 2.5% phenylephrine ophthalmic metered spray, similar to Mydcombi, Eyenovia’s commercially available product for inducing mydriasis. Twenty-nine subjects completed the study and administered one spray. Baseline pupil diameter (PD) for all eyes was 2.74±0.48 mm. Mean change in PD from baseline to 30 minutes was 3.69±1.25 mm. At 30 minutes post-dosing, mean PD was 6.42±1.25 mm, with 67% and 43% of eyes dilated to ≥ 6mm and 7mm, respectively. The majority of patients returned to functional vision (PD ≤ 5 mm) as early as 3.5 hours post-instillation, with 93% reaching that point by six hours. Safety outcomes were favorable, as only mild adverse events were reported (dry eye and mild instillation site pain) all of which resolved without intervention. “We conducted this study to address questions from doctors about modulating dosing for patients who may benefit from a lower dose of tropicamide or phenylephrine,” stated Dr. Julie Whitcomb, Senior Director of Medical Affairs at Eyenovia. “What we found in this study was that a half dose may also provide clinically relevant pupil dilation, was well-tolerated, and had a desirable shorter duration of effect.” Presentation details: Title:An Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Tropicamide 1% and Phenylephrine 2.5% Ophthalmic Spray (MydCombi®)Poster:#109, Exhibit Hall HPresenter:Dr. Josianne Manasse, OD, SUNY College of OptometryDate/time:Friday, November 8th, 1:00-3:00pm For additional information on the Expo: https://aaopt.org/meetings/academy-2024-indianapolis/ About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-surgical pain and inflammation, as well as the ongoing late-stage development of medications in the Optejet device for pediatric progressive myopia as well as out-licensing for additional indications. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05% Forward-Looking StatementsExcept for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including the timing and scale of acceptance and use of our approved products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, Inc.Andy Jones Chief Financial Officerajones@eyenovia.comEyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

都说“金眼、银牙、铜骨”，眼科疾病繁多、覆盖人群广，在我国老龄化加速的时代，是医疗投资界公认的未来“黄金赛道”。 欧康维视是国内为数不多专注眼科领域的企业，并逐渐成为国内炙手可热的眼科新贵之一。 近日，欧康维视又放出大招。 携手全球眼科大王 欧康维视生物宣布与爱尔康达成协议，将从爱尔康获得8款干眼症治疗和手术用滴眼液产品组合的在华相关权益，包括7款已经上市的成熟产品和1款处于临床开发阶段的产品。 一路走来，产品引进的经历在欧康维视身上习以为常，发展初期包括在港交所上市之后，为解决无核心产品难题及丰富管线布局，欧康维视管主要通过License-in来铺眼药的产品管线，并依托License-in快速商业化，合作对象包括晖致、美国生物制药Eyepoint、汇恩兰德、Nicox等公司。 表1 欧康维视部分引进产品信息 数据来源：公开信息整理 其中，最有代表性的当属用于累及眼后段的慢性非感染性葡萄膜炎（慢性NIU-PS）的核心产品OT-401（优施莹）的引进及商业化。 OT-401在2018年10月在美国获批的3周后，欧康维视获得该产品的大中华地区开发和商业化权益，并开始后续开发，于2022年6月在国内上市，是首款且唯一可以持续稳定在眼内释放氟轻松，用于治疗眼部慢性非感染性葡萄膜炎的first in class药物，是中国药品注册史上第一个完全基于真实世界研究数据申报上市的新药，其获批填补了国内葡萄膜炎治疗领域的空白，在国内市场上，OT-401尚无竞品。 OT-401已在2023年12月纳入国家医保，据统计，自新版医保目录实施以来，OT-401在今年上半年内已完成了近2000针注射，亮眼的数据充分展示了其市场潜力和患者对其的高度认可，OT-401有望助力欧康维视在慢性NIUPS领域蹚出一条新路。 与以往以现金、收购等合作模式略有不同，本次与爱尔康的合作是以股权转让的方式进行，根据新闻稿，欧康维视将向爱尔康/Alcon Inc.发行139,159,664股股份，占总股本的16.71%（发行后），爱尔康/Alcon Inc.将成为欧康维视的最大股东之一。 加码干眼症领域 为何欧康维视本次愿意以出让股权的方式引进产品？答案肯定在产品上。 根据新闻稿，欧康维视将在中国市场上完全获得爱尔康的7个成熟产品新泪然®（Tears Natural®Forte）、倍然（Bion Tears）、爱尔凯因®（Alcaine®）、历设得（Fluorescite）、赛飞杰（Cyclogyl）等的产品权益，以及候选物思然®和AR-15512在中国的商业化权利。其中新泪然、泪然II、倍然、思然、AR-15512（在研）均为干眼症药物。 干眼症已成为我国患者最多的眼科疾病。据《国人干眼多中心大数据报告》数据，目前中国干眼症患者约有3.6亿人，每年可能新增10%，经常使用视频终端者干眼发病率高达93%，佩戴隐形眼镜患者患病率高达90%，干眼正在成为继近视眼之后又一国民用眼健康问题，国内干眼症药物的市场规模逐渐增大。 据灼识咨询，中国干眼症患者2019年达2.14亿人，其中0.86亿人为中重症患者，约占患者总数40%。数据显示，2019年干眼症药物销售总额为21.96亿元，至2023年已达40.53亿元，四年复合增长率达到16.56%。 鉴于干眼症的市场潜力，当前的中国干眼症赛道早已暗流涌动，诸多的本土企业通过仿制、自主研发或合作的方式纷纷入局，除欧康维视，兴齐眼药、亿胜生物、远大医药、恒瑞医药、和铂医药、全福生物、康哲药业、未名生物、熙健医药等企业均有布局。 其中，环孢素滴眼液被认为是目前治疗干眼症最为有效的药物，且已经成为美国干眼症领域最为畅销的药品之一。在国内，兴齐眼药的环孢素滴眼液赛道领跑，其三类仿制药0.05%环孢素滴眼液（Ⅱ）（商品名“兹润”）已在2020年获批上市。 资料显示，兹润的2023年销售额为3.5亿元，同比增长123%，销售峰值有望达10亿元。除了兴齐眼药之外，如兆科眼科、康哲药业、和铂医药和恒瑞医药等企业也在开发环孢素滴眼液，兆科眼科开发的干眼症创新药——环孢素A眼凝胶的上市申请于2022年6月获国家药监局受理。 其他创新干眼症药物研发方面，不少国内企业也有突破，恒瑞医药从Novaliq引进的CyclASol（0.1%环孢菌素A制剂）SHR8058滴眼液（又称NOV03）于去年3月申报上市；和铂医药授权引进的特那西普滴眼液（HBM9036，环孢素）也已经进展到Ⅲ期临床；全福生物科的治疗干眼症的新药BRM421自2022年12月启动第Ⅲ期人体临床试验，远大医药的治疗干眼症的小分子多肽药物GPN00136(BRM421)的也处在临床Ⅱ期。 目前，欧康维视现有的主要干眼症产品有2款，为已经商业化的玻璃酸钠滴眼液欧沁，以及正处于临床开发阶段的OT-202（酪氨酸激酶抑制剂）。 其中，欧沁是从汇恩兰德手里引进，而OT-202是欧康维视自主研发的作用于脾酪氨酸激酶（syk）和血管内皮生长因子（VEGF）的双靶点抑制剂具有同类首创潜力，是中国眼科为数不多的全新靶点创新药，目前已达到II期临床试验的主要终点，在安全性及疗效方面展现出积极的结果，预计今年下半年进入III期临床。 从已上市的产品看，虽然欧康维视的欧沁成功获批，且玻璃酸钠眼用制剂是医院市场销售规模最大的干眼症眼药水，市场占比超25%；但是国内玻璃酸钠滴眼液市场的大部分份额仍被国外企业德国悟兹法姆药业和参天制药包揽，份额超八成，其余份额则由珠海联邦、齐鲁制药、浙江尖峰药业等企业分享。 从在研产品来看，OT-202虽为同类首创，但是研发进度落后于恒瑞医药、和铂医药以及全福生物科的候选物，欧康维视并没有太多的优势在干眼症领域脱颖而出。 本次引进的候选药物AR-15512具有同类首创潜力，预计将于2024年提交FDA申请，爱尔康这几款成熟干眼症产品和AR-15512的加入可以使欧康维视缩短竞争的时间差，进一步提升欧康维视在干眼症市场的竞争地位。 根据爱尔康财报，这几款从爱尔康引进的产品主要属于爱尔康的视力保健业务产品。爱尔康2024年Q1财报显示，视力保健业务净销售额为4.35亿美元，增长5%，主要受到眼药水产品系列的推动。而在2023年年报中，视力保健业务实现了16.56亿美元的销售额，同比增长17%，是属于各个板块增长势头最好的业务板块。 为商业化添翼， 为国际化开路 眼科是一个由诸多细分疾病的赛道，除了干眼症市场，其他眼科疾病领域欧康维视也在发力。 不含本次引进的爱尔康的产品，欧康维视现有产品管线中拥有25个药物资产，全面覆盖了眼前节和眼后节的主要适应症。 其中，12个产品处于商业化阶段，3款产品处于III期临床试验阶段，3款产品处于上市注册申报阶段，持续保持在中国眼科药物领域处于III期临床及上市注册阶段数量最多的创新药企之一。 图1 欧康维视管线 图片来源：欧康维视官网 除了看上爱尔康的产品，欧维康视力还有自己的“小算盘”。 含从爱尔康引进的7款成熟产品，欧康维视目前有近20款的产品处在商业化阶段，对于商业化能力的需求之高可想而知。好的商业化需要有效的产品梯队，更需要有强大的商业化团队和渠道，才能快速实现产品的商业化价值。 爱尔康，作为全球眼科护理的领导者，为超过140个国家的患者提供了广泛的产品组合，产品足迹遍布全球，目前在国内市场已深耕30多年，其商业化团队对市场的洞察力和执行力是其他药企难以比拟的。据悉，爱尔康在华的眼科药物商业化团队将全部并入欧康维视生物，双方将共同开拓市场。 也就是说，虽说欧康维视本身的商业化能力也不错，根据8月12日发布的半年报，2024上半年欧康维视商业化产品实现营业收入达到1.68亿元，同比增长61.6%。其中欧沁（玻璃酸钠滴眼液）、埃美丁（依美斯汀滴眼液）、适利达（拉坦前列素滴眼液）等多款产品均实现了市场份额的稳步攀升，核心产品迅速放量，产品的销售佳绩不断累积。 但是本次合作之后，爱尔康也将为欧康维视带来宝贵的商业化经验与资源，尤其是在院外渠道的拓展上，进一步增强其产品变现能力。 另外，国际化，让产品走向世界是每个医药企业的梦想，对于欧康维视也不例外，本次与爱尔康合作，爱尔康将成为欧康维视的最大股东之一，根据协议，爱尔康拥有欧康维视产品在海外的优先谈判权，爱尔康的渠道和品牌优势，能够在最短时间内帮助欧康维视的产品在海外市场实现快速增长，为欧康维视注入国际化基因，打开未来产品走向国际的想象空间。 结语 在中国，眼科疾病很普遍，但治疗率却很低，远远落后于美国。根据弗若斯特沙利文的资料，中国眼科医药市场预计由2019年的人民币194亿元增至2024年的人民币408亿元，复合年增长率为16.0%。 欧康维视正努力往眼科的市场中心狂奔，本次与爱尔康的这次牵手，会碰撞出怎样的火花，拭目以待。 参考资料： 1、《深度丨百亿蓝海市场，干眼症药物市场及研发概述》医药智投 2、《头部眼科药企跨国合作，一次现象级的BD交易》氨基观察 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。 责任编辑 | 史蒂文 转载开白 | 马老师 18996384680（同微信） 商务合作 | 王存星 19922864877（同微信）  阅读原文，是受欢迎的文章哦