Introduction Graft-versus-host disease (GVHD) is a common sequela of hematopoietic stem cell transplant (HSCT). While HSCT is often curative for certain hematologic malignancies, acute and chronic GVHD remains an important cause of morbidity and mortality in post-transplant patients. Ocular involvement is one manifestation of chronic GVHD that can present similarly to chronic dry eye with tear film abnormalities, aqueous deficiency, and corneal epithelial defects through melting and perforation. Current management includes frequent use of artificial tears and oral or topical glucocorticoids as tolerated. There is a need for long-term, steroid-sparing therapeutics in the management of ocular GVHD (oGVHD). Lifitegrast is approved for the treatment of chronic dry eye and may have therapeutic potential in the treatment of oGVHD. The aim of this study was to investigate the efficacy and safety of topical lifitegrast in the management of oGVHD. Methodology A prospective randomized clinical trial (NCT04792580) was performed on 32 enrolled patients with diagnosed oGVHD. Subjects underwent a two-week washout period consisting of preservative-free artificial tears dosed twice a day, after which they were randomized to the treatment arm (5% lifitegrast ophthalmic solution) or placebo arm (vehicle solution) for four weeks. Endpoints included Symptom Assessment iN Dry Eye (SANDE) score, unanesthetized Schirmer score, Ocular Surface Disease Index questionnaire score, fluorescein staining, tear film breakup time, meibum quantity, and turbidity. Safety endpoints included intraocular pressure, visual acuity, and rate of treatment-related adverse effects. Statistical analysis was done with a t-test or Wilcoxon rank-sum test. Results The primary and secondary efficacy endpoints were met, with statistically significant reductions in mean SANDE and unanesthetized Schirmer score observed at four weeks post-randomization. No serious adverse events related to the use of either lifitegrast or vehicle were observed, and no worsening of visual acuity or intraocular pressure occurred in the intention-to-treat analysis. However, further inference was limited due to insufficient statistical power owing to significant washout and a 50% dropout rate from the all-enrolled analysis set. The most common causes of study dropout were worsening of unrelated medical conditions (not GVHD) and improvement of SANDE score or Schirmer score outside of the inclusion criteria range during the washout period. Conclusions Lifitegrast may be a useful steroid-sparing agent in the long-term management of oGVHD. This study provides further support for the clinical evidence of lifitegrast in the management of dry eye signs and symptoms, although further sufficiently powered clinical trials are warranted to better understand its efficacy in the oGVHD population. Personalized treatment options targeting distinct manifestations of oGVHD in the cornea, tear film, lid margin, and conjunctiva are needed in the effective management of this multifaceted and complex disease.

2024-06-02·Bioanalysis

An LC-MS/MS method for the determination of Lifitegrast in human plasma and tear and its application in the pharmacokinetic study

Article

作者: Qi, Wen ; Boping, Wei ; Daiguo, Zhao ; Min, Yang ; Xiao, Ke ; Xingxiang, Lv ; Juan, Cai ; Weixun, Lv ; Xiaorong, He

Aim: A new, selective and simple UPLC-MS/MS method was developed and validated for the determination of lifitegrast in human plasma and tear in order to obtain PK data. Materials & methods: Lifitegrast-d4 solutions were added in the samples, and then were extracted and transferred to a UPLC vial. Results: The respective working ranges were 25.00-2000.00 pg/ml in plasma and 4.00-1000.00 μg/ml in tear. The fully validated method complied with existing regulatory criteria for accuracy and precision, recovery, etc. It was applied to plasma and tear samples, which were from a clinical study, successfully. Conclusion: This method is useful in the evaluation of lifitegrast in plasma and tear.

2024-05-01·Journal of pharmaceutical and biomedical analysis

A specific chiral HPLC method for lifitegrast and determination of enantiomeric impurity in drug substance, ophthalmic product and stressed samples

Review

作者: Ozkan, Sibel A ; Uğur, Merve ; Bellur Atici, Esen

Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist used to treat the indications and symptoms associated with dry eye disease (DED), one of the most common ocular surface diseases. Lifitegrast has a chiral center, and the S-enantiomer (S-Lif) is responsible for the therapeutic effects, while the R-enantiomer (R-Lif) lacks efficacy in the treatment of DED. Lifitegrast ophthalmic solution containing 5% lifitegrast was approved by the United States Food and Drug Administration (FDA) in July 2016 for the treatment of DED in patients 17 years of age and older. The objective of this study was to develop a chiral HPLC method for the determination of the enantiomeric impurity of lifitegrast in the drug substance and in the ophthalmic product. In addition, we aimed to investigate the effect of stress and stability conditions on the enantiomeric purity of lifitegrast in both drug substance and ophthalmic solution. During the method development studies, four known lifitegrast impurities (Lif. Imp. A-D) and stressed lifitegrast samples were injected to ensure the specificity of the developed method. The enantiomers of lifitegrast are well separated with a resolution of higher than 4.0. They are also well separated from the peaks of the diluent, impurities, and the placebo used to prepare the ophthalmic solution without interference in 20 min. Chiral separation was achieved using a Chiralpak AD-H column (250 × 4.6 mm, 5.0 μm) at 40 °C with a mobile phase consisting of a mixture of n-hexane, 2-propanol, and formic acid (500:500:2, v/v/v) at a flow rate of 1.0 mL/min and a detection wavelength of 260 nm. Methanol was used as the diluent, and the drug substance solution was found to be stable for 48 h at 15 °C. The optimized chiral HPLC method for lifitegrast was validated according to ICH Q2, and the calibration curves showed excellent linearity for R-Lif (0.0369 - 1.816 µg/mL). This is the first stability-indicating, specific / selective, sensitive, linear, precise, accurate, and robust chiral HPLC method for the determination of R-Lif in S-Lif. The amount of enantiomeric impurity R-Lif in S-Lif increased under all stress and photostability test conditions without exceeding the acceptable impurity limit, with the most significant increase observed at elevated temperatures (105 °C) for both the drug substance in powder form and the ophthalmic drug solution.

项与利非司特相关的新闻（医药）

2024-09-24

·赛柏蓝

风靡全球的眼科巨头，可能「易主」

编者按：本文来自药智医械；赛柏蓝授权转载，编辑相宜近日，据英国《金融时报》（Financial Times）消息，规模全球第二的眼科巨头博士伦（Bausch Lomb）正在寻求自身出售，从而与其母公司博士康（Bausch Health）彻底分拆。近年来，博士康在并购策略的实施之下，业务管线全面发展，但因身陷巨额债务危机，不得不减负瘦身，博士伦就是本次其出售分拆的目标之一。 01 成也并购，“败”也并购博士伦于1853年创立于美国纽约，2022年于纽交所和多伦多证券交易所同步上市，如今已有近170年的发展历史。起初，博士伦仅是一家小型眼镜店，多年发展之下，已成为世界知名的眼睛保健公司之一。从产品管线来看，博士伦拥有从隐形眼镜、彩色隐形眼镜，到隐形眼镜护理液的全线眼睛健康产品。如今，博士伦全球大约10000名员工，产品已销往100多个国家。 2013年，博士康的前身——加拿大制药巨头Valeant以87亿美元的价格从美国华平投资集团手中买走博士伦。博士伦的加入，让Valeant一跃成为彼时世界上最大的隐形眼镜生产厂商之一，而博士伦则保留原有名称，成为其旗下子公司。这笔收购让Valeant得以跻身全球最大的15家医药企业行列，并使其眼药、隐形眼镜以及隐形眼镜护理用品的产品管线得到延展，更是新增了眼科手术设备和仪器等产品。 2020年8月，博士康官宣博士伦品牌将以独立公司运营。独立后博士伦估值200亿至300亿美元之间，估值一度逼近眼科全球老大爱尔康，成为世界第二大眼科器械公司。据百度股市通，截至9月20日收盘，博士伦最新市值为70.24亿美元。图片来源：百度股市通本次博士康出售博士伦的原因为博士康的巨额债务，成也并购、“败”也并购，博士康这一系列债务也源于其并购策略。自2008年以来，博士康的前身Valeant“痴迷”于并购带来的收益，已完成近100项收购，而在起初的几年中，并购策略也确实为其带来不小的收益。但转折从2015年开始，2015年年底，Valeant遭遇一系列风波。如陷入提价策略和使用专业药房分销药物的争议之中、会计欺诈指控等，结果就是Valeant股价一落千丈，彼时的Valeant已承担了总额超过300亿美元的债务。在2017年的大部分时间里，Valeant都在“瘦身”自救。 2018年7月，Valeant正式更名为博士康。博士康的高管们向投资者提出了计划，希望能再次增加收入，并开始积极偿还巨额债务。但效果并不显著，如今博士康仍面临210亿美元的巨额债务，其中近100亿美元的债务将在2027年底到期。此处需要注意的是，博士康明星产品Xifaxan的专利将于2029年到期，债务危机与专利悬崖迫在眉睫。博士伦作为世界第二大眼科器械公司，其产品价值宝贵之处无需多言，也正因如此成为博士康瘦身减负的目标之一，目前博士康持有博士伦88%的股份。据媒体报道，博士伦目前正在评估潜在买家的兴趣，希望通过出售来绕过投资者为分拆设立的障碍。摩根大通分析师Robbie Marcus分析，博士伦出售给私募股权投资者似乎是最有可能的，因为其与爱尔康、强生或库珀公司的交易可能会因这些企业在隐形眼镜市场的份额而面临反垄断审查。出售给类似艾伯维这样的制药公司也很有可能具有挑战性，因为其在干眼症市场的份额很大。并且该分析师指出，博士伦在母公司多年投资不足之后，其隐形眼镜和手术产品组合将需要大量投资才能具有竞争力，因此潜在投资者想要在完成收购后通过削减成本再转手出售来获利不太现实。 02 多项业务稳定增长博士伦何去何从目前仍是未解之谜，但从博士伦本身而言，其自身实力相当可圈可点。据博士伦Q2财报，其第二季度营收12.16亿美元，同比增长17.5%，但净利润亏损1.51亿美元，另有46亿美元的长期债务。从业务板块来看：视力保健业务稳定增长中，2024Q2季度收入6.97亿美元，同比增长8%。主要由于消费者眼部护理业务中的干眼症产品组合、LUMIFY®（酒石酸溴莫尼定眼用溶液 0.025%）和眼部维生素以及隐形眼镜业务中的多焦点硅水凝胶（SiHy）日抛隐形眼镜和ULTRA®的销售。外科手术业务也在持续增长，2024Q2季度收入2.09亿美元，同比增长7%。主要由于高端IOL产品组合推动对设备和耗材以及植入物的需求增加。眼科药物业务在该季度增长迅猛，2024Q2季度收入3.1亿美元，同比增长60%。主要由于收购 XIIDRA ®、MIEBO ®强劲表现以及美国仿制药和国际业务的持续增长。博士伦在2024年第二季度中，所有部门都呈现出强劲的增长势头，并且随着处方药和非处方药产品的增长，博士伦在干眼症产品领域的领导地位得到加强。此外，博士伦也推出了多款创新新产品，包括干眼症营养补充剂、INFUSE散光日抛隐形眼镜、EnVista Envy三焦点IOL。中国市场也是博士伦十分看重的区域，早在1987年博士伦便已进入中国市场，是最早进入中国的外资品牌之一。目前博士伦在中国有三家独立运行的公司，分别是北京博士伦眼睛护理产品有限公司、博士伦（上海）贸易有限公司和山东博士伦福瑞达制药有限公司。其中，北京博士伦主要生产和销售眼睛护理产品，包括透明镜片，彩色镜片，护理产品等；上海博士伦主要产品为眼科手术产品，包括白内障、玻璃体视网膜手术设备、人工晶体、相关耗材和手术器械等；山东博士伦主营为眼科药品、外科药品、皮肤科药品及内科药品系列的研制和生产能力，其眼科产品“润舒”、“润洁”及骨关节炎治疗用药“施沛特”成为国内知名品牌。此外，博士伦也在积极开展与中国本土企业及机构的合作，进一步扩大在华布局。 03 结语在今年8月的财报电话会议上，博士康CEO Thomas Appio 表示：“博士伦的全面分离仍然是一个战略优先事项”。据外媒援引知情人士消息，包括黑石集团、Advent International、TPG Capital、CVC Capital和Hellman & Friedman在内的私募股权公司正在评估对博士伦可能提出的收购要约。从博士康中分拆而出，无论对于博士伦或是博士康来说都是一件双赢的好事，静待后续的发展。 END 内容沟通：郑瑶（13810174402）医药代理商产品交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

并购专利到期

2024-09-24

·米内网

【聚焦】齐鲁入局17亿注射剂

精彩内容近日，CDE官网显示，齐鲁制药的注射用硫酸多黏菌素B以仿制3类报产获受理，该产品2023年在中国公立医疗机构终端的销售额超过17亿元。今年以来，齐鲁制药有25个品种以新注册分类提交上市/临床申请，其中12个暂无首仿（含剂型首仿）获批。硫酸多黏菌素B是一组从多黏芽孢杆菌中分离出的抗菌性多肽，通过改变细菌细胞膜通透性导致细菌死亡，主要用于绿脓杆菌及其他假单胞菌引起的创面、尿路以及眼、耳、气管等部位感染，也可用于败血症、腹膜炎等。米内网数据显示，注射用硫酸多黏菌素B已被纳入国家医保乙类目录，目前仅上药第一生化拥有生产批文。该产品近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端迅速放量，2021年突破10亿元，2022-2023年均超过17亿元。近年来中国公立医疗机构终端注射用硫酸多黏菌素B销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局仿制药申报方面，有10家企业的注射用硫酸多黏菌素B以新注册分类报产在审，包括倍特药业、汇宇制药、利泰尔药业、亿帆生物、华北制药、齐鲁制药、健康元药业、Xellia制药、四川上善六经医药、湖南埃威格林医药。米内网数据显示，今年以来，齐鲁制药已有25个品种以新注册分类提交上市/临床申请，涵盖10个治疗大类，集中在神经系统药物（6个）、全身用抗感染药物（5个）、心脑血管系统药物（4个）等治疗领域。 2024年至今齐鲁制药以新分类申报的品种来源：米内网中国申报进度（MED）数据库 25个品种中，瑞卢戈利片、奥氮平萨米多芬片、来特莫韦注射液、阿巴帕肽注射液、芦曲泊帕片、布瑞哌唑片、布瑞哌唑口崩片、丙酸氟替卡松鼻喷雾剂、醋酸地非法林注射液、注射用奥氮平、立他司特滴眼液、西尼莫德片12个品种暂无仿制药（以药品名称计）获批；注射用硫酸多黏菌素B、来特莫韦片、美阿沙坦钾片、丁酸氯维地平脂肪乳注射液等品种目前拥有生产批文的国内企业仅有1家。资料来源：米内网数据库、CDE官网等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至9月24日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

专利侵权

2024-08-05

·GlobeNewswire-Health Care

4DMT Advances Leadership in Large Market Ophthalmology with Senior Management Hires and Formation of Ophthalmology Advisory Board

Dhaval Desai, PharmD, named as Chief Development Officer; will oversee late-stage Product Development, Medical Affairs, Scientific Communications, Regulatory and Quality operations; most recently SVP & Chief Development Officer at Iveric Bio where he led development and approval of IZERVAYChristopher Simms named as Chief Commercial Officer, effective September 25, 2024; will oversee Pre-commercial and Commercial organizations, pre-launch preparations and development; most recently SVP & Chief Commercial Officer at Iveric Bio where he led commercial strategy and execution for the launch of IZERVAYCarlos Quezada-Ruiz, M.D., FASRS, named as SVP, Therapeutic Area Head, Ophthalmology; will lead the Ophthalmology franchise and oversee early- and late-stage clinical development; most recently Group Medical Director, Ophthalmology at Genentech where he led clinical development and approval of VABYSMO and SUSVIMOOphthalmology Advisory Board comprised of world-renowned retina specialists and thought leaders to support development strategy and registration for large market ophthalmology programs: Dr. Arshad Khanani (Chair), Dr. David Boyer, Dr. Frank Holz, Dr. Anat Loewenstein, Dr. Dante Pieramici EMERYVILLE, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today strengthened the Company’s senior management team with the appointments of Dhaval Desai, PharmD, as Chief Development Officer, Christopher Simms as Chief Commercial Officer and Carlos Quezada-Ruiz, M.D., FASRS, as SVP, Therapeutic Area Head, Ophthalmology. Dr. Desai will lead 4DMT’s late-stage Product Development, Medical Affairs, Scientific Communications, Regulatory and Quality operations. Mr. Simms will lead 4DMT’s Pre-commercial and Commercial organizations, effective September 25, 2024. Both Dr. Desai and Mr. Simms will join 4DMT’s Executive Team, reporting to David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. Dr. Quezada-Ruiz will lead the Ophthalmology franchise and oversee early- and late-stage ophthalmology clinical development, reporting to Bob Kim, M.D., Chief Medical Officer of 4DMT. With the addition of Dr. Desai, An Song, Ph.D., will transition from Chief Development Officer to Chief Research & Translational Development Officer. “With the continued promise of 4D-150 as a pipeline-in-a-product, I am thrilled to have Dhaval, Chris and Carlos join the 4DMT team and bring their wealth of large market ophthalmology, regulatory, drug development and commercial experience to our company as we transition into Phase 3 development and pre-commercialization,” said Dr. Kirn. “Dhaval, Chris and Carlos’s leadership is vital to becoming a leading late-stage development genetic medicines company, with a focus on large market ophthalmic diseases. We believe the expansion of our senior leadership team with extensive ophthalmology experience will allow us to execute on our development objectives to design and rapidly enroll large global Phase 3 pivotal trials, and subsequently to make successful global regulatory submissions.” “It is a privilege to join 4DMT at this stage of rapid progress and to be able to focus my development expertise to bring these important product candidates to patients as effectively and efficiently as possible,” said Dr. Desai. “My experience working on pivotal Phase 3 programs and U.S. Food and Drug Administration (FDA) submissions in multiple large market retinal indications will complement the already stellar team that David and 4DMT have built. I look forward to collaborating and partnering with the entire 4DMT team to increase the strength of our ophthalmology portfolio, progress 4D-150 through late-stage development, and prepare for potential BLA submissions in the coming years.” “Joining 4DMT at this time of growth is truly an incredible opportunity to contribute to the planning and potential introduction of transformational medicines in multiple large market ophthalmology indications like wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy (DR) and geographic atrophy (GA),” said Mr. Simms. “I look forward to building a leading commercial strategy and infrastructure in support of late-stage development, registration and ultimately, commercialization. My experience in large market ophthalmology commercial strategy and execution helps fortify and bring 4DMT’s exceptional product pipeline of potentially paradigm shifting treatments to patients who need them most.” “I am thrilled to join 4DMT and bring my drug development expertise, people and patient focus, to lead and further build 4DMT’s outstanding ophthalmology team ahead of the initiation of our first pivotal Phase 3 trial in wet AMD early next year, and to rapidly accelerate our development programs in additional large-market diseases including DME, DR and GA,” said Dr. Quezada-Ruiz. “As a medicines developer and practicing retina specialist, I am most excited about the potential of gene therapy to improve outcomes for our patients and believe that the greatest unmet need in treating wet AMD, DME, and now GA, is greater durability. Having played a leading role in the global development and approvals of VABYSMO and SUSVIMO, I have seen firsthand the positive impact that novel mechanisms of action and sustained durability have for patients, caregivers and physicians. Similarly, 4D-150’s potential to achieve sustained efficacy and extended durability should significantly reduce patients’ treatment burden while also maintaining vision through a safe, single intravitreally delivered gene therapy injection. I look forward to contributing to 4DMT’s mission to bring transformative genetic medicines to millions of patients in need around the world.” The Company also announced the formation of the Ophthalmology Advisory Board (OAB), comprised of world-renowned retina specialists and thought leaders. The OAB will be chaired by Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates and Clinical Professor at University of Nevada, Reno, and will support development strategy and registration across large market ophthalmology indications including wet AMD, DME, DR and GA. “The wealth of clinical and global drug development experience that has been brought together under the OAB, in addition to our new senior leadership hires, provides 4DMT with unparalleled expertise in large market ophthalmology development,” added Dr. Kim. “As we prepare for our first Phase 3 clinical trial, the OAB will provide substantial support to maximize the value of our deep pipeline of retinal genetic medicines programs across multiple retinal disease indications. I look forward to working with our OAB members and new senior leaders to bring these important medicines to patients globally.” Senior Management Hires Dhaval Desai, PharmD, Chief Development OfficerDr. Desai has spent the past 20+ years working in all aspects of drug development with a focus on clinical development and medical affairs. Prior to joining 4DMT, Dr. Desai was SVP and Chief Development Officer at Iveric Bio (acquired by Astellas) where he led the clinical development, medical affairs and biostatistics departments responsible for the approval and launch of IZERVAY™, one of the first complement inhibitors approved for the treatment of GA. Before Iveric, Dr. Desai served as VP and Medical Unit Head of Ophthalmology at Novartis Pharmaceuticals, overseeing both the posterior and anterior segment therapeutic portfolios. In addition to these roles, Dr. Desai has also held leadership positions at other ophthalmology-focused biotech companies including Aerpio Therapeutics and ThromboGenics. Dr. Desai received his PharmD from and completed a post-doctoral industry fellowship at Rutgers University. Chris Simms, Chief Commercial OfficerMr. Simms is an accomplished healthcare leader with more than 20 years of diverse commercial leadership experience at Iveric Bio (acquired by Astellas), Johnson & Johnson, Genentech and Novartis, including focused experience in retina, ophthalmology and optometry. Most recently he was SVP and Chief Commercial Officer at Iveric where he built and led the commercial team from pre-commercialization through the successful U.S. launch of IZERVAY™. Prior to joining Iveric, Mr. Simms served as Vice President and Head of the Novartis U.S. Ophthalmics business unit which included the brands BEOVU® and Xiidra®. He joined Novartis in 2017 to build the commercial launch strategy for BEOVU® after leading commercial efforts on LUCENTIS® at Genentech. Prior to Genentech, he spent 16 years at Johnson & Johnson working with leading brands across their vision care, diabetes and consumer goods businesses in Canada, Japan and the U.S. Mr. Simms has a Bachelor of Commerce from Memorial University of Newfoundland and an MBA from York University, Toronto, Canada. Carlos Quezada-Ruiz, M.D., FASRS, SVP, Therapeutic Area Head, OphthalmologyDr. Quezada-Ruiz joins 4DMT from Genentech (a Roche company) where he served in the Ophthalmology management team as Group Medical Director, Clinical Science, Product Development. During his tenure at Genentech, he led the design, execution and readouts for U.S. and global registrational trials across multiple retinal diseases, including the wet AMD global clinical development program for VABYSMO, leading to U.S. and global approvals and the global clinical science team for SUSVIMO, supporting its initial FDA approval and launch in wet AMD, successfully leading his team through the U.S. voluntary recall and recent commercial relaunch. In addition, he led the DR and DME Phase 3 registrational programs. Dr. Quezada-Ruiz also oversaw the Medical Affairs team efforts for the U.S. launch of Lucentis Prefilled Syringe (PFS) and the Myopic Choroidal Neovascularization indication for LUCENTIS. Additionally, he played a pivotal role in the advancement of personalized healthcare in retina within Genentech by helping design and develop predictive models using machine learning and large language models to support drug development and clinical practice. Dr. Quezada-Ruiz is a practicing retina specialist and fellow of the American Society of Retina Specialists, with over 13 years of vitreoretinal clinical practice and research. Dr. Quezada-Ruiz received his M.D. from Universidad Autónoma de Coahuila, and completed fellowships in Vitreoretinal Surgery, Ocular Pathology-Research, and Retinal Disease and Vitreoretinal Surgery Research from Universidad Nacional Autónoma de México, McGill University, and the California Retina Research Foundation. He obtained a CIBE from Columbia Business School, Executive Education. Ophthalmology Advisory Board Arshad M. Khanani, M.D., M.A., FASRS (Chair): Managing Partner, Director of Clinical Research and Director of Fellowship at Sierra Eye Associates, and Clinical Professor at the University of Nevada, Reno School of Medicine. He has served as the principal investigator for more than 120 clinical trials and has over 150 scientific publications. Dr. Khanani is an elected member of the Macula Society and Retina Society. He has received numerous awards of distinction including the prestigious American Society of Retina Specialists (ASRS) Presidents’ Young Investigator Award and the ASRS Presidential Award. David S. Boyer, M.D.: Senior Partner at the Retina-Vitreous Associates Medical Group, and an Adjunct Clinical Professor of Ophthalmology at the University of Southern California/Keck School of Medicine in Los Angeles, California. He is a board-certified ophthalmologist specializing in the treatment of diseases of the retina and vitreous, and a leading clinical researcher for new treatments in macular degeneration and DME. Frank G. Holz, M.D., FEBO, FARVO: Professor and Chairman of the Department of Ophthalmology at the University of Bonn, Germany. He founded the GRADE Reading Center and the Medical Imaging Center Bonn, with a focus on innovative retinal imaging technologies and image analysis strategies. His research focuses on the pathogenesis, structural and functional biomarkers, and new therapies for macular and retinal diseases. He has published more than 600 articles in peer-reviewed journals and has received numerous awards including the Pro Retina Macular Degeneration Research Award, the Leonhard-Klein Award for Ocular Surgery, the Alcon Research Institute (ARI) Award, the Senior Achievement Award of the AAO and the Jules Gonin Award. Anat Loewenstein, M.D., MHA: Professor and Director, Division of Ophthalmology at the Tel Aviv Medical Center, VP Ambulatory Services at the Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at Tel Aviv University, Israel, and President of EURETINA. She has published more than 500 papers in peer reviewed journals and has contributed multiple chapters to ophthalmology textbooks. Her focus is the investigation of drug administration and toxicity to the retina, early detection of macular degeneration and home monitoring of retinal disease. Dante Pieramici, M.D.: Managing Partner at California Retina Consultants, President of the California Retina Research Foundation, a member of the Medical Leadership Board of the Retina Consultants of America. Currently, he is the Medical Director of Clinical Research at California Retina Consultants. Dr. Pieramici has served as the principal, sub, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic-related eye diseases. About 4DMT 4DMT is a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology. 4DMT’s proprietary invention platform, Therapeutic Vector Evolution, combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our wholly owned and partnered product candidates. Our product design, development, and manufacturing engine helps us efficiently create and advance our diverse product pipeline with the goal of revolutionizing medicine with potential curative therapies for millions of patients. Currently, 4DMT is advancing six clinical-stage and one preclinical product candidate, each tailored to address rare and large market diseases in ophthalmology, pulmonology and cardiology. In addition, 4DMT is also advancing programs in CNS through a gene editing partnership. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT. All of our product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. No representation is made as to the safety or effectiveness of our product candidates for the therapeutic uses for which they are being studied. Learn more at www.4DMT.com and follow us on LinkedIn. Forward Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential, and clinical benefits and market potential of 4DMT’s product candidates, as well as the plans, announcements, and related timing for the clinical development of, regulatory interactions regarding, and potential commercialization of 4D-150 and 4D-175 and 4D-150's potential to be a pipeline-in-a-product. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward looking statements. Contacts: Media:Katherine SmithInizio Evoke CommsKatherine.Smith@inizioevoke.com Investors:Julian PeiHead of Investor Relations and Corporate FinanceInvestor.Relations@4DMT.com

高管变更临床3期

100 项与利非司特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10374	利非司特	S01XA25	DB11611

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
DED	美国	Bausch & Lomb, Inc.	2016-07-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
干眼症	临床3期	中国	成都普什制药有限公司	2022-02-17
干眼症	临床3期	中国	成都康弘药业集团股份有限公司	2022-02-17
干燥综合征性角膜结膜炎	临床3期	美国	Shire Plc	2011-08-29
变应性结膜炎	临床2期	美国	Shire Plc	2009-04-24
移植物抗宿主病	临床1期	美国	Novartis Pharmaceuticals Corp.	2022-10-22
糖尿病性黄斑水肿	临床1期	美国	SARcode Bioscience, Inc.	2009-08-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO2021	N/A	DED	600	Lifitegrast	鹹蓋艱憲鏇廠鬱製願齋(襯遞築鬱繭願蓋夢選艱) = 獵獵網醖淵窪齋淵淵鹹構遞廠壓築膚衊鏇壓願 (願廠蓋襯築鑰衊糧餘築 ) 更多	-	2021-06-01
AAO2019	N/A	DED	27	Lifitegrast	構廠顧範顧壓鏇製選夢(積鏇鹹網選夢窪醖衊壓) = 憲餘蓋選膚齋壓壓夢憲築廠選鹽淵製齋襯壓艱 (襯憲膚繭鹹膚選糧憲繭 ) 更多	-	2019-10-12
OPUS-2, OPUS-3 (AAO2017)	临床3期	DED	-	Lifitegrast	簾遞鑰鑰窪壓齋遞糧簾(廠網糧艱齋鏇齋獵積糧) = 餘衊鏇鑰製衊簾鹽憲簾壓鑰鏇繭糧鹽選構鏇淵 (選蓋廠齋壓網齋獵鬱簾 ) 更多	-	2017-11-13
OPUS-2, OPUS-3 (AAO2017)	临床3期	DED	-	Placebo	簾遞鑰鑰窪壓齋遞糧簾(廠網糧艱齋鏇齋獵積糧) = 糧簾蓋蓋範憲鏇窪觸選壓鑰鏇繭糧鹽選構鏇淵 (選蓋廠齋壓網齋獵鬱簾 ) 更多	-	2017-11-13
EULAR2017	N/A	DED	-	Lifitegrast ophthalmic solution 5.0%	夢築廠膚醖顧鬱膚觸範(鑰製繭艱襯鬱遞齋築糧) = 鬱鏇窪簾獵餘選獵襯衊糧鑰鏇遞鹹選淵鹽膚膚 (醖鑰簾鑰餘築蓋鹽襯鹹 )	积极	2017-06-14
NCT02284516 (OPUS-3, CTgov)	临床3期	DED	711	Placebo (Placebo)	網餘膚選築憲廠獵糧繭(齋襯齋願遞構製憲獵繭) = 夢網齋淵餘醖獵膚糧餘艱壓襯壓構鏇餘製齋糧 (鹽醖憲顧願醖觸繭鏇齋, 網範衊範廠餘衊鑰製製 ~ 願鹽鹽觸範窪廠餘簾醖) 更多	-	2017-03-15
NCT02284516 (OPUS-3, CTgov)	临床3期	DED	711	Lifitegrast (Lifitegrast)	網餘膚選築憲廠獵糧繭(齋襯齋願遞構製憲獵繭) = 鑰繭窪蓋餘鬱醖獵廠糧艱壓襯壓構鏇餘製齋糧 (鹽醖憲顧願醖觸繭鏇齋, 鬱廠製鏇願鑰製願鏇蓋 ~ 鬱網願艱齋選艱範獵積) 更多	-	2017-03-15
NCT00926185 (CTgov)	临床2期	DED	230	Placebo	獵夢齋齋窪遞積壓醖顧(選鏇鬱積襯遞鑰餘獵繭) = 餘夢獵鬱齋鑰壓獵壓鹹鏇製鬱鑰糧醖簾醖鬱壓 (醖築鹹選獵積襯鹹遞範, 憲顧醖廠窪蓋獵繭繭構 ~ 淵築鏇艱觸夢顧積襯顧) 更多	-	2017-03-06
NCT01421498 (OPUS-1, CTgov)	临床3期	干燥综合征性角膜结膜炎	588	Placebo	遞遞簾構願膚糧選夢廠(選餘衊齋願憲顧餘遞廠) = 鏇觸鑰積壓窪獵築糧願網艱網積憲鬱選鏇遞獵 (製遞憲顧膚醖壓壓觸範, 齋廠簾襯網憲選網膚鏇 ~ 鬱窪製蓋鬱築觸膚觸淵) 更多	-	2017-02-24
NCT00882687 (CTgov)	临床2期	变应性结膜炎	60	Placebo	衊鏇鏇鏇夢齋積糧夢鬱(繭鏇齋齋願鑰醖餘廠鹽) = 觸鑰鹹蓋鏇選餘鹹糧廠膚鬱顧鹽窪憲夢製鬱壓 (鏇積獵廠積餘鹽積鹽壓, 網衊膚淵餘選積鹽鏇繭 ~ 築醖齋淵鬱醖顧鬱鹹鏇) 更多	-	2017-02-24
NCT01743729 (OPUS-2, CTgov)	临床3期	DED	720	Lifitegrast (Lifitegrast)	鹽淵醖簾淵壓膚憲蓋鹹(鏇製遞鹽鑰觸選積築鏇) = 顧鑰願製製遞顧獵淵醖鬱糧艱餘艱構網壓願獵 (蓋構憲夢鹹憲窪構願選, 築餘夢顧夢襯廠襯襯網 ~ 觸鑰艱淵廠製製遞範襯) 更多	-	2017-02-24
NCT01743729 (OPUS-2, CTgov)	临床3期	DED	720	Placebo (Placebo)	鹽淵醖簾淵壓膚憲蓋鹹(鏇製遞鹽鑰觸選積築鏇) = 餘構鏇餘壓構鹽窪鬱壓鬱糧艱餘艱構網壓願獵 (蓋構憲夢鹹憲窪構願選, 繭壓餘觸膚齋衊鑰構遞 ~ 淵齋齋膚夢觸繭觸簾餘) 更多	-	2017-02-24
NCT01636206 (SONATA, CTgov)	临床3期	DED	332	Placebo (Placebo)	衊衊窪築鹹餘膚廠範網(齋醖廠淵襯獵餘範壓糧) = 獵選鏇窪積構餘膚範鹹壓繭壓廠簾積餘鹽醖構 (艱蓋醖觸艱積遞觸網鏇, 憲簾鹽憲淵鬱製積齋糧 ~ 夢獵餘鹽遞膚醖鏇遞鏇) 更多	-	2016-10-03
NCT01636206 (SONATA, CTgov)	临床3期	DED	332	Lifitegrast (Lifitegrast)	衊衊窪築鹹餘膚廠範網(齋醖廠淵襯獵餘範壓糧) = 範遞願構醖鹽糧繭網餘壓繭壓廠簾積餘鹽醖構 (艱蓋醖觸艱積遞觸網鏇, 鑰壓範鏇鑰壓鹹顧夢艱 ~ 網淵網憲壓製齋蓋鹽壓) 更多	-	2016-10-03