Dorzolamide Hydrochloride/Timolol Maleate

▎药明康德内容团队编辑 “我深深敬仰Jack，他是我的人生导师。他不仅是一位杰出的药物化学家，更是一位品德高尚的智者与长者。Jack，请安息！我将永远怀念您！愿天下没有难做的药，难治的病！” ——药明康德董事长兼首席执行官李革博士 全球知名药物化学家、多款新药背后的化学英雄John（Jack）Baldwin博士于3月22日与世长辞，享年91岁。消息传来，令人深感痛惜。Baldwin博士毕生致力于新药研发事业，他是产业界的巨匠，更是一位值得敬仰的挚友和永远怀抱理想、勇于开拓的同行者。 Baldwin博士的一生，是以科学造福患者的一生。在明尼苏达大学获得有机化学博士学位后，他加入默沙东（MSD）实验室，开启了一段辉煌的药物研发生涯。在随后的30多年间，Baldwin博士将一个个复杂的有机分子化为治病救人的良方。 他的身影活跃在眼科、心血管疾病、消化系统疾病、传染性疾病等广泛疾病领域，多款重磅新药诞生的背后都离不开他的突出贡献：两款治疗青光眼的新药Trusopt和Cosopt问世，为大量患者延续了光明；Crixivan至今仍广泛与其他抗逆转录病毒药物联合使用，让HIV感染不再是“不治之症”；Aggrastat则帮助急性冠状动脉综合征患者降低血栓风险；还有他深度参与研发的胃肠道溃疡药物Pepcid、利尿剂Edercin等等……如今，Baldwin博士虽已远去，这些药物成为他留给人间的礼物，仍在世界各地守护着患者的健康。 创新药物诞生背后是坚实的科学基石。Baldwin博士一生发表150多篇出版物，拥有超过250项专利。因为发现重要药物活性物质的成就，Baldwin博士获得美国化学会颁发的E.B. Hershberg奖，并在2007年入选了美国化学会名人堂。多项殊荣见证了他对基础科学和临床转化的卓越贡献，更映照出他始终炽热如初的科学之心。 迈出实验室，Baldwin博士也是一位富有胆识与担当的连续创业者。他先后创立了多家生物制药公司，向攻克难以成药靶点、解决未满足医学需求的目标发起挑战。在这些公司中，治疗2型糖尿病等疾病的新药已相继问世，此外还有多款处于临床阶段的药物蕴育着改写治疗格局的希望。在创业历程中，他与同行携手搭建起全球合作的桥梁，共同推动创新药物的研发与应用。 真正的创新者，既能默默耕耘于实验室的方寸之间，又能勇敢地架起连接科学与人类福祉的桥梁，让科技之光照亮生命之路。Baldwin博士倾尽一生践行着用科学改变疾病的理念，拯救了无数患者的生命。这个世界将永远记得他所带来的改变。 传奇虽已谢幕，精神终将不朽。永远怀念、致敬Baldwin博士。 Farewell to a Legend: Remembering Dr. John "Jack" Baldwin “I deeply admire Jack -  he was a true mentor in my life. He was not only a great medicinal chemist but also a wise and noble elder. Rest in peace Jack! I will always cherish your memory. May every drug be made and every disease be treated!”  — Dr. Ge Li, Chairman and CEO of WuXi AppTec Dr. John "Jack" Baldwin, a globally renowned medicinal chemist whose groundbreaking contributions underpin numerous new medicines, passed away on March 22 at the age of 91. His loss is deeply mourned by all who had the privilege of knowing him. Throughout his lifetime, Dr. Baldwin dedicated himself tirelessly to advancing drug discovery. He was not just a giant within the pharmaceutical industry but also a cherished friend and an inspirational colleague known for his relentless pursuit of innovation and his pioneering spirit. Dr. Baldwin devoted his life to using science to improve patients' lives. After earning his Ph.D. in organic chemistry from the University of Minnesota, he embarked on a distinguished career at Merck Research Laboratories, where, for over three decades, he advanced complex organic molecules into transformative therapeutic solutions. His contributions were extensive and spanned multiple therapeutic areas, including ophthalmology, cardiovascular diseases, gastrointestinal disorders, and infectious diseases. Among the groundbreaking drugs developed with his invaluable contributions were Trusopt and Cosopt, which significantly advanced glaucoma treatment and restored vision for countless patients; Crixivan, widely used in combination with other antiretroviral therapies, transformed HIV treatment and turned what was once a fatal diagnosis into a manageable condition; Aggrastat greatly reduced the risk of thrombosis in acute coronary syndrome patients; Pepcid offered effective relief for gastrointestinal ulcers; and Edercin, a vital diuretic medication. Although Dr. Baldwin has passed away, these new medicines continue to protect and improve the lives of patients worldwide. Innovative drugs originate from foundational scientific research. Throughout his prolific career, Dr. Baldwin published over 150 scientific papers and was inventor to more than 250 patents. His discovery of crucial bioactive molecules earned him notable honors, including the prestigious E.B. Hershberg Award from the American Chemical Society (ACS), and his induction into the ACS Hall of Fame in 2007. These accolades reflect his extraordinary contributions to fundamental science and clinical translation, highlighting his lifelong passion for scientific discovery. Beyond his research, Dr. Baldwin was also a bold and visionary entrepreneur. He founded several biotechnology companies focused on addressing challenging therapeutic targets and meeting critical medical needs. His ventures successfully developed new therapies for diseases such as type 2 diabetes, while several other promising drugs currently in clinical trials hold the potential to transform future treatment approaches. Throughout his entrepreneurial journey, Dr. Baldwin fostered global collaborations, building bridges with international colleagues to further innovative drug research and its clinical application. True innovators, like Dr. Baldwin, tirelessly work behind the scenes in laboratories and courageously forge connections between scientific advancement and human health, illuminating pathways toward a healthier future. His impact on medicine and humanity will be remembered forever. Although his journey has concluded, Dr. Baldwin’s extraordinary legacy will forever be honored and remembered with deep respect and great admiration. 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

IYUZEH™ (latanoprost ophthalmic solution) 0.005%, the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), is now available in the U.S. WALTHAM, Mass., Sept. 26, 2023 /PRNewswire/ -- Thea Pharma Inc. ("Thea"), the U.S. subsidiary of Europe's leading independent ophthalmic-focused pharmaceutical company, Théa, dedicated to the research, development, and commercialization of ophthalmic products, today announced the launch and availability of IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S. market. Preservative-free latanoprost, launched over ten years ago, is available in 46 countries, mostly under the brand name MONOPROST®, with about 1.5 million patients treated monthly.1 IYUZEH is the first and only preservative-free latanoprost for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT) in the U.S. In randomized, controlled clinical trials of patients with POAG or OHT with mean baseline intraocular pressure (IOP) of 19-24 mmHg, IYUZEH lowered IOP by 3–8 mmHg compared to 4–8 mmHg by XALATAN®.2-4 Experience the full interactive Multichannel News Release here: "The U.S. launch of IYUZEH is a major step forward for Théa Group, the eye care community, and patients," said Jean-Frédéric Chibret, President of Théa. "Glaucoma is a chronic eye disease that affects the everyday lives of more than 60 million people globally. With IYUZEH now available, eye care providers can effectively treat their POAG and OHT patients with preservative-free latanoprost. I would like to thank everyone involved in achieving this milestone – including the providers and patients who participated in the clinical studies, our teams, and each of our partners – for helping us deliver on our commitment to enable patients access to medication without preservatives." "With the launch of IYUZEH in the U.S., Thea is responding to an important unmet need in the treatment landscape. IYUZEH brings similar efficacy of traditional latanoprost, formulated without preservatives, to help eye care providers confidently address their treatment goals of lowering intraocular pressure for people with POAG and OHT," said Susan Benton, President of Thea Pharma Inc. "We are thrilled to introduce IYUZEH and provide clinicians with an important new treatment option for their patients." "With the availability and proven efficacy of IYUZEH, it is now possible for eye care providers to lower elevated intraocular pressure in patients with POAG or OHT without preservatives on the ocular surface," said Jason Bacharach, M.D., Founder and Director of Research at North Bay Eye Associates in Petaluma, California. "This is a powerful option for our patients and for us, as treating clinicians." IYUZEH is available now through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651), NDC (82584-003-30). From enrollment to dispensing, Thea is committed to supporting eye care professionals and patients in every step of the access process. IYUZEH (latanoprost ophthalmic solution) 0.005% is now available for as little as $60 for a 30-day supply through programs with PhilRx® and the Thea Savings Card. For more information and eligibility requirements, please visit iyuzeh.com. PhilRx is a service that provides a convenient way to prescribe IYUZEH, with the medication shipped for free and directly to a patient's door. This service offers online and phone support for both eye care professionals and their patients. The Thea Savings Card is available to those commercially insured and not enrolled in a state or federally funded program. A patient may check their eligibility and activate this savings card at activatethecard.com/theasavingscard. Whether a physical or digital card, it can be utilized or redeemed at any retail pharmacy in the U.S. Thea is committed to helping patients have access to IYUZEH. A Patient Assistance Program is available for eligible U.S. patients that have a demonstrated financial need and are without prescription insurance coverage. With this program, we aim to allow every qualified patient the chance to see their treatment with eyes wide open. About IYUZEH™ IYUZEH™ (latanoprost ophthalmic solution) 0.005%, an opalescent, white to slightly yellow ophthalmic solution, is a topical formulation of latanoprost that is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). IYUZEH™ does not contain a preservative – it is the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), in the United States. The recommended dosage of IYUZEH™ is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. IOP reduction is present for at least 24 hours. In the two clinical trials conducted with IYUZEH™ (latanoprost ophthalmic solution) 0.005%, the most frequently reported ocular adverse reactions were conjunctival hyperemia (34%) and eye irritation (19%) compared to XALATAN®, the preserved 0.005% latanoprost reference product which reported conjunctival hyperemia (37%) and eye irritation (31%). Healthcare providers, patients, and caregivers can learn more about IYUZEH at iyuzeh.com. INDICATIONS AND USAGE IYUZEH is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to latanoprost or any other ingredients in this product. WARNINGS AND PRECAUTIONS Pigmentation: Topical latanoprost ophthalmic products, including IYUZEH™ have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with IYUZEH™ can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes: Latanoprost ophthalmic products, including IYUZEH™ may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment. Intraocular Inflammation: IYUZEH™ should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated. Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost ophthalmic products, including IYUZEH™. IYUZEH™ should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Herpetic Keratitis: Reactivation of herpes simplex keratitis has been reported during treatment with latanoprost. IYUZEH™ should be used with caution in patients with a history of herpetic keratitis. IYUZEH™ should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated. Contact Lens Use: Contact lenses should be removed prior to the administration of IYUZEH™ and may be reinserted 15 minutes after administration. ADVERSE REACTIONS The following adverse reactions have been reported with the use of topical latanoprost products: iris pigmentation changes, eyelid skin darkening, eyelash changes (increased length, thickness, pigmentation, and number of lashes), intraocular inflammation (iritis/uveitis), and macular edema, including cystoid macular edema. DRUG INTERACTIONS The combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH™ is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. For more information about IYUZEH™, please visit iyuzeh.com. For Full Prescribing Information, please visit . About Primary Open-angle Glaucoma The American Glaucoma Society states that glaucoma is a common ophthalmic disorder characterized by typical optic nerve damage and vision loss. It is most associated with elevated or dysregulated intraocular pressure, although there is evidence that other factors contribute to the disease.5 Glaucoma is a leading cause of irreversible blindness worldwide. Its prevalence in the U.S. is approximately 1,900 per 100,000 persons over age forty, and the condition is responsible for upwards of nine million clinic visits each year.6-8 In the U.S., where annual spending on optic nerve disorders is estimated at $5.8 billion annually,9 glaucoma is a significant public health concern. About Ocular Hypertension Mean IOP slowly rises with increasing age. Age older than 40 years is considered a risk factor for the development of OHT and POAG.10 OHT, a common condition, is a leading risk factor for the development of OAG.11 OHT is defined as IOP consistently greater than 21 mmHg (in at least one eye) and the absence of clinical signs of glaucoma.12 The risk of developing glaucoma increases with increasing IOP.13 Population studies such as the Framingham, Beaver Dam, Baltimore, Rotterdam, Barbados, and Egna-Neumarkt studies estimate that 4-10% of the population older than 40 years will have IOP levels of 21 mmHg or higher without detectable signs of glaucomatous damage. OHT has a 10-15 times greater prevalence than POAG.14 The use of topical IOP-lowering medications reduced the risk of glaucoma development from 9.5% in the control group to 4.4% in the intervention group.15 About Théa Laboratoires Théa is an independent pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, it has thirty-five affiliates & offices in Europe, North and South America, North Africa, and the Middle East. Today, its network includes nearly 1,900 employees, and its products are available in 75 countries around the world. In 2022, Théa had global revenues of approximately $941 million. The independent and family-owned and run group, founded from a Research and Development start-up by Henri Chibret, has been chaired since 2008 by Jean-Frédéric Chibret, his nephew. To learn more about Théa Group, visit . About Thea Pharma, Inc. Thea Pharma, Inc., is the United States subsidiary of Théa. Its product offering is comprised of a portfolio of seven leading eye-care products that are regulated or approved by the U.S. Food and Drug Administration (FDA), including Zioptan®, AcellFX™, Cosopt®, Cosopt® PF, Azasite®, Akten®, and Betimol®, iVIZIA™ dry-eye drops and eyelid hygiene products, and now IYUZEH™. By focusing our passion and expertise within the U.S. market, Thea Pharma's goal is to deliver uncompromising care that allows all stakeholders to envision the future of ophthalmic treatment with eyes wide open. To learn more about Thea Pharma, Inc., visit . References: Théa. Data on file. 2023. IYUZEH™ (latanoprost ophthalmic solution) 0.005%. Prescribing information. Thea Pharma Inc; 2022. Bacharach J, Ahmed IIK, Sharpe ED, Korenfeld MS, Zhang S, Baudouin C. Preservative-Free versus Benzalkonium Chloride–Preserved Latanoprost Ophthalmic Solution in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3 US Clinical Trial. Clin Ophthalmol. 2023;17:2575-2588. . Rouland JF, Traverso CE, Stalmans I, et al. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97(2):196–200. doi:10.1136/bjophthalmol-2012-302121. The American Glaucoma Society (AGS). Unmet needs in the detection, diagnosis, monitoring, treatment, and understanding of primary open angle glaucoma. 2021; 11. . Accessed March 1, 2023. Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol. 2004;122(4):532–538. doi:10.1001/archopht.122.4.532. Schappert SM. Office Visits for Glaucoma: United States, 1991-92. Vital and Health Statistics, Centers for Disease Control and Prevention / National Center for Health Statistics. 1995; March, No. 262. Lee PP, Walt JG, Doyle JJ, et al. A multicenter, retrospective pilot study of resource use and costs associated with severity of disease in glaucoma. Arch Ophthalmol. 2006;124(1):12–19. doi:10.1001/archopht.124.1.12. Wittenborn JS, Zhang X, Feagan CW, et al. The economic burden of vision loss and eye disorders among the United States population younger than 40 years. Ophthalmology. 2013;120(9):1728–35. . Leske MC, Connell AM, Wu SY, et al. Distribution of intraocular pressure. The Barbados Eye Study. Arch Ophthalmol. 1997 Aug. 115(8):1051-7. Kass MA, Heuer DK, Higginbotham EJ, et al. Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up. JAMA Ophthalmol. 2021;139(5):558–566. doi:10.1001/jamaophthalmol.2021.0341. Burr JM, Botello-Pinzon P, Takwoingi Y, Hernandez R, Vazquez-Montes M, Elders A, et al. Surveillance for ocular hypertension: an evidence synthesis and economic evaluation. Health Technol Assess. 2012;16(29):1-271, iii-iv. Burr JM, Mowatt G, Hernandez R, Siddiqui MAR, Cook J, Lourenco T, et al. The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma: a systematic review and economic evaluation. Health Technol Assess. 2007;11(41):iii-iv, ix-x, 1-190. Chihara E. Assessment of true intraocular pressure: the gap between theory and practical data. Surv Ophthalmol. 2008 May-Jun. 53(3):203-18. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: A Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-Angle Glaucoma. Arch Ophthalmol. 2002;120(6):701-713. doi:10.1001/archopht.120.6.701. PRC-IYZ-1676-v2 SOURCE Thea Pharma Inc.