Lifitegrast

精彩内容4月3日，齐鲁制药提交了恩他卡朋双多巴片(II)的4类仿制上市申请。恩他卡朋双多巴是一款畅销抗帕金森氏病药，2022年在中国公立医疗机构终端的销售额超过1亿元。今年以来，齐鲁制药已有4个新产品获批，6个新产品申报上市。图1：齐鲁制药最新申报的产品来源：CDE官网图2：国内市场已上市的恩他卡朋双多巴制剂来源：米内网中国上市药品（MID）数据库恩他卡朋双多巴是卡比多巴、恩他卡朋和左旋多巴的三联复方制剂，适用于治疗经左旋多巴/多巴脱羧酶(DDC)抑制剂疗法未能控制的出现或伴有“剂末”运动功能波动的成人帕金森病患者。米内网数据显示，目前国内市场上已有原研的恩他卡朋双多巴片、恩他卡朋双多巴片(II)、恩他卡朋双多巴片(III)、恩他卡朋双多巴片(IV)上市销售，4个产品均未有国产仿制药获批。图3：恩他卡朋双多巴的销售情况（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恩他卡朋双多巴在2019年进入国家医保目录，随后在中国城市公立医院、县级公立医院、城市社区及乡镇卫生院（简称中国公立医疗机构）终端的销售额飞速增长，2022年突破1亿元。2023年上半年在抗帕金森氏病药市场，恩他卡朋双多巴为TOP6品种。2022年12月，石家庄四药首家提交了恩他卡朋双多巴片(II)的4类仿制上市申请，目前正在审评审批中。本次齐鲁报产，将参与该产品的国内首仿争夺。表1：2024年至今齐鲁制药获批的新产品（按批文日期统计）来源：米内网中国申报进度（MED）数据库今年以来，齐鲁制药及子公司已获批了4款新产品，其中艾曲泊帕乙醇胺片为国内首仿（含同日获批），公司的抢仿实力不容小觑。值得注意的是，今年以来齐鲁制药及子公司已提交了6个新产品的仿制上市申请，包括了西尼莫德片、盐酸尼卡地平注射液、注射用米卡芬净钠、注射用拉氧头孢钠、立他司特滴眼液和恩他卡朋双多巴片(II)，其中西尼莫德片、立他司特滴眼液和恩他卡朋双多巴片(II)暂无国内药企获得生产批文。资料来源：CDE官网、米内网数据库等注：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4月3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

Presentations Will Feature Studies Evaluating TENEO™ Excimer Laser Platform, MIEBO® (Perfluorohexyloctane Ophthalmic Solution) and enVista® Envy* and IC-8® Apthera™ IOLs VAUGHAN, Ontario--(BUSINESS WIRE)-- Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced fifteen podium and four poster presentations during the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting, which will take place in Boston, April 5-8, 2024. Podium presentations include the results of studies evaluating the new TENEO Excimer Laser Platform, enVista and IC-8 Apthera intraocular lenses (IOLs) and MIEBO. MIEBO is indicated for the treatment of the signs and symptoms of dry eye disease. Poster presentations include the results of TENEO and IC-8 Apthera IOL studies. In addition to these scientific presentations, the company will also sponsor educational events focused on these and other Bausch + Lomb products. Bausch + Lomb activities at ASCRS: Podium Presentations “Assessment of the Spectacle Independence and Visual Outcomes Following Bilateral Implantation of a Novel Toric IOL* Among Cataract Patients.” Harasymowycz et al. “Binocularity and Stereoacuity in Modern Monovision with a Small-Aperture IOL.” Wiley et al. “Characterization of Discontinuation and Switching Patterns of Dry Eye Disease Medications Using Linked EHR Registry and Claims Data.” Mbagwu et al. “Clinical Results of Small-Aperture IOL Implantation Following Corneal Inlay Removal.” Ang et al. “Defocus Curve Performance of a Novel Hydrophobic Acrylic Trifocal Intraocular Lens*: A Prospective, Multicenter Canadian Study.” Muzychuk et al. “Early Real World Outcomes of Small Aperture IOL in Post Refractive Eyes.” Hu et al. “Outcomes of an Ultra-Low Cylinder Powered (0.90 D) Toric versus Non-Toric IOL in Low Astigmatic Patients Undergoing Cataract Surgery.” Muzychuk et al. “Patient-Reported Instillation Comfort and Eyedrop Acceptability of Perfluorohexyloctane Ophthalmic Solution in Pivotal Clinical Studies.” White et al. “Patient-Reported Outcomes Following LASIK, Performed Using a Novel Excimer Laser for the Correction of Myopia and Myopic Astigmatism.” Stonecipher et al. “Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease: Efficacy Among Various Participant Subgroups in Pivotal Clinical Trials.” Sheppard et al. “Predicted In-Vitro versus In-vivo Measurements of Higher-Order Corneal Aberrations following Apthera Implantation Post Radial Keratotomy.” Devaro et al. “Quality of Vision and Clinical Outcomes of a Novel Trifocal IOL* Implanted Bilaterally After Cataract Surgery: A Canadian Multicenter Study.” Harasymowycz et al. “Subjective versus Objective Depth of Focus from Ray-Tracing Aberrometry in Small Aperture Optics Intraocular Lens in Eyes with Aberrated Corneas.” Barros et al. “Visual and Refractive Outcomes following Bilateral Implantation of a Novel Trifocal* or Monofocal IOL: A Prospective, Multicenter US study.” Liang et al. “Visual Performance of Negative versus Neutral Aspheric Monofocal Intraocular Lenses: A Randomized Controlled Trial.” Kudrna et al. Poster Presentations “Binocular Visual Outcomes and Defocus Curve of Bilaterally Implanted Novel Trifocal Intraocular Lens*: A Prospective, Multicenter US study.” Shultz et al. “Estimation of Visual Benefit with IC-8 in Keratoconus Patients.” Klyce et al. “Initial Results Using Small Aperture Optics IOL in Patients with or without Prior Ocular Surgery, Corneal Scarring or Irregular Astigmatism.” Shultz et al. “Outcomes of LASIK Performed Using the Updated Laser Ablation Algorithm for the Correction of Myopia and Myopic Astigmatism.” Chu et al. Featured Educational Events Friday, April 5 “Rethinking Dry Eye Disease: A Contemporary Approach to a Complex Condition” 7:15-9:15 p.m. ET at Davio's Seaport (26 Fan Pier, Boston) The program will feature the dynamic duo of Laura Periman, M.D., and Darrell White, M.D., who will discuss MIEBO and XIIDRA® (lifitegrast ophthalmic solution) 5%. Saturday, April 6 “Refractive Redefined: TENEO, the New FDA Approved Excimer Laser” 3:00-3:50 p.m. ET in the at the Boston Convention & Exhibit Center (415 Summer Street, Boston; ASCRS Tap Room) Join George Waring IV, M.D., to learn more about the accuracy, efficiency and usability advantages of TENEO, the first excimer laser platform approved in nearly two decades. “Innovations in DED and Novel Cataract Surgery Technologies” 6:30-8:00 p.m. ET at the Omni Boston at the Seaport (450 Summer Street, Boston; Momentum Ballroom, Level 5) Join moderator Eric Donnenfeld, M.D., along with presenters Marjin Farid, M.D., Ravi Patel, M.D., and Karl Stonecipher, M.D., to learn more about the benefits of and differences between MIEBO and XIIDRA, as well as the benefits of using the new enVista Aspire lens for doctors and their patients. Sunday, April 7 Innovator’s Session Featuring Andrew Stewart, President, Global Pharmaceuticals and International Consumer 10:00am—11:30am, ASCRS Main Stage *enVista Envy is pending PMA approval and is not approved for sale in the United States or its territories ### Important Safety Information for MIEBO INDICATION MIEBO® (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION Patients should remove contact lenses before using MIEBO and wait for at least 30 minutes before reinserting. It is important for patients to use MIEBO exactly as prescribed. It is not known if MIEBO is safe and effective in children under the age of 18. The most common eye side effect seen in studies was blurred vision (1% to 3 % of patients reported blurred vision and eye redness). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information for MIEBO. WHAT IS XIIDRA? XIIDRA (lifitegrast ophthalmic solution) 5% is a prescription eye drop used to treat the signs and symptoms of dry eye disease. IMPORTANT SAFETY INFORMATION Do not use XIIDRA if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an allergic reaction. The most common side effects of XIIDRA include eye irritation, discomfort or blurred vision when the drops are applied to the eyes, and an unusual taste sensation. To help avoid eye injury or contamination of the solution, do not touch the container tip to your eye or any surface. If you wear contact lenses, remove them before using XIIDRA and wait for at least 15 minutes before placing them back in your eyes. It is not known if XIIDRA is safe and effective in children under 17 years of age. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information for XIIDRA. Indications and Important Safety Information for Technolas Teneo 317 Model 2 System Indications for Use. The Technolas Teneo 317 Model 2 is indicated for laser-assisted in situ keratomileusis (LASIK) in: (1) Patients for the reduction or elimination of myopic astigmatism up to -10.00 D MRSE, with sphere between -1.00 D and cylinder between 0.00 and -3.00 D; (2) Patients who are 22 years of age or older; (3) Patients must have a stable refraction in the last 12 months, as documented by previous clinical recordings, i.e., the spherical and cylindrical portions of the manifest distance refraction have not progressed at a rate of more than 0.50 D per year prior to the baseline examination in the eye(s) to be treated. WARNING. Danger of injury due to failure to observe the patient selection criteria! Failure to observe the contraindications and potential adverse effects may result in serious permanent patient injury. The usage of the laser system is limited to a specific field of applications. Observe the contraindications and potential adverse effects listed in the User Manual before selecting a patient and starting any treatment. Contraindications. Contraindications of the Technolas Teneo 317 Model 2 include patients: (1) with any type of active connective tissue disease or autoimmune disease; (2) with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea (including but not limited to pellucid marginal degeneration); (3) with significant dry eyes (severe Dry Eye Syndrome). If patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK; (4) for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250µ of residual corneal thickness from corneal endothelium; (5) with uncontrolled diabetes; (6) with uncontrolled glaucoma; (7) with active eye infections or active inflammation: (8) with recent herpes eye infection or problems resulting from past infections; (9) with known sensitivity to medications used for standard LASIK surgery. Potential Risks and Side Effects: (1) Miscreated flap; (2) Subconjunctival hemorrhage or bleeding; (3) Wrinkles in flap that may require a flap lift; (4) Corneal erosion/abrasion, epithelia defect; (5) Elevated IOP; (6) Debris or foreign body under flap; (7) Epithelial ingrowth under flap; (8) Debilitating visual symptoms, especially at night; (9) Decreased or fluctuating visual acuity; (10) Decreased ability to see in low-light conditions; (11) Light sensitivity; (12) Dry Eye syndrome; (13) Inadequate treatment result; (14) Regression; (15) Corneal damage; (16) Posterior vitreous detachment or retinal detachment, floaters or vascular accidents; (17) Foreign body sensation or pain (initial postoperative days); also, potentially including chronic eye pain that is resistant to therapy referred to as neuropathic pain; (18) Infection/inflammation; (19) CTK (Central Toxic Keratopathy); (20) Medication intolerance; (21) Ptosis; (22) Cataract; (23) Ocular penetration; (24) Potential risk of psychological harm. This is not all you need to know. Please see the User Manual for a complete list of safety information, including a full list of contraindications, warnings, precautions and risks. Caution: Federal (U.S.) law restricts this device to sale, by or on the order of a physician. Indications and Important Safety Information for IC-8 Apthera IOL INDICATIONS: The IC-8 Apthera IOL is indicated for unilateral implantation for the visual correction of aphakia and to create monovision in patients of age 22 or older who have been diagnosed with bilateral operable cataract, who have up to 1.5 D of astigmatism in the implanted eye, and who do not have a history of retinal disease and who are not predisposed to experiencing retinal disease in the future. The device is intended for primary implantation in the capsular bag, in the non-dominant eye, after the fellow eye has already undergone successful implantation (uncorrected distance visual acuity 20/32 or better and best-corrected distance visual acuity 20/25 or better) of a monofocal or monofocal toric IOL that is targeted for emmetropia. The refractive target for the IC-8 Apthera IOL should be -0.75 D. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal or monofocal toric IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. CONTRAINDICATIONS: (1) Patients with dilated pupil size less than 7.0 mm. (2) Patients with a history of retinal disease including but not limited to, high myopia, diabetes, macular disease, sickle cell disease, retinal tear, retinal detachment, retinal vein occlusion, ocular tumor, uveitis, and patients who are predisposed to experiencing retinal disease in the future. WARNINGS: The lens should not be implanted if appropriate intraocular support of the lens is not possible. Severe subjective visual disturbances (e.g., glare, halo, starburst, hazy vision) may occur after device implantation. There is a possibility that these visual disturbances may be significant enough that a patient may request removal of the lens. Contrast sensitivity in eyes implanted with this lens is significantly reduced when compared to the fellow eye implanted with a monofocal or monofocal toric IOL. Although there was no significant reduction in binocular contrast sensitivity in the IDE clinical study, it is essential that prospective patients be fully informed of this visual effect in the implanted eye before giving their consent for unilateral implantation of the lens. Patients should be informed that they may need to exercise caution when engaging in activities that require good vision in dimly lit environments (such as driving at night or in poor visibility conditions). There is a possibility that visual symptoms due to reduced contrast sensitivity may be significant enough that a patient may request removal of the lens. This lens should not be implanted bilaterally because bilateral implantation is expected to cause significant reduction in contrast sensitivity under all lighting conditions. The use of this lens in patients with corneal astigmatism greater than 1.5 D is not recommended. Diagnostic tests in patients implanted with the lens may take longer and require some additional effort from the patient and the physician to perform. Use of some medical lasers to treat certain eye conditions may present potential risks of damaging the FilterRing component of the lens. Removal of the lens may be necessary prior to retinal or vitreal procedures. Surgeons should perform a careful benefit-risk assessment based on individual patient characteristics, weighing all the risks disclosed in the Directions for Use labeling against the benefit of extended depth of focus. Nd:YAG laser capsulotomy treatments may be more difficult to perform and may be less effective in an IC-8 Apthera IOL implanted eye. Specific training from Bausch & Lomb, Inc. or its authorized representative related to YAG capsulotomy is required before a surgeon is authorized to implant the IC-8 Apthera IOL. PRECAUTIONS: Prior to surgery, prospective patients should be informed of the possible risks and benefits associated with this lens and a Patient Information Brochure should be provided to the patient. Patients with a predicted postoperative astigmatism between 1.0 D and 1.5 D may not obtain as great an amount of improvement in intermediate vision compared to patients with lower amounts of astigmatism. CAUTION: Federal law restricts this device to sale by or on the order of a licensed physician. ATTENTION: Reference the Directions for Use labeling for a complete listing of important safety information. About Bausch + Lomb Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit and connect with us on X, LinkedIn, Facebook and Instagram. Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. ©2024 Bausch + Lomb. MTB.0113.USA.24