The aim of this study is to evaluate the efficacy of intra-operative phentolamine vs intraoperative esmolol for hypotensive anesthesia in functional endoscopic sinus surgery.

开始日期2024-10-10

申办/合作机构

Ain Shams University

NCT06422494 / Not yet recruitingN/AIIT

The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II

The goal of this trial is to study the effect that adrenaline has on the immune reaction seen during a low blood sugar. People with type 1 diabetes do not produce their own insulin. The cells in the pancreas that produce insulin are destroyed. People with type 1 diabetes require daily insulin administration. As a consequence of this insulin therapy the blood sugar can dip too low, causing symptoms such as confusion, irritation and tiredness. This is called hypoglycaemia. Hypoglycaemia has been associated with an increased risk for cardiovascular disease such as heart attacks. During hypoglycaemia the immune system is activated. The immune system consists of white blood cells which produce cytokines, these are proteins used to kill pathogens such as bacteria. During hypoglycaemia there are no pathogens but the cytokines are still produced, leading to unwanted damage. A previous study performed by our research group showed that the immune system activation caused by hypoglycaemia is associated with the stress hormone adrenaline. Adrenaline is released by the body in moments of stress such as during running or bungee jumping. Adrenaline is also released by the body during hypoglycaemia to increase the sugar level. Our hypothesis is that adrenaline activates the immune system during hypoglycaemia. Adrenaline acts in the body through two receivers, these are called alpha and beta receptors. These are present on almost all cells in the body especially on the immune cells. With the study we want to study the situation where there is a hypoglycaemia without the adrenaline. We will achieve this by lowering the blood sugar in participants. During the low blood sugar we will administer two drugs, which will attach themselves to the adrenaline receivers, the alpha and beta receptor. With this method we hope to block the adrenaline effects and with that block the immune response caused by adrenaline.

开始日期2024-09-01

申办/合作机构

Radboud University Medical Center

NCT06542497 / Recruiting临床3期

Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia

Safety and efficacy of POS in participants with presbyopia

开始日期2024-08-15

申办/合作机构

Opus Genetics, Inc.

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100 项与甲磺酸酚妥拉明相关的专利（医药）

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项与甲磺酸酚妥拉明相关的文献（医药）

2024-12-01·Cell Stem Cell

A human organoid drug screen identifies α2-adrenergic receptor signaling as a therapeutic target for cartilage regeneration

Article

作者: Lai, Ruijun ; Yang, Jun ; Huang, Shijiang ; Lin, Zhijie ; Qiu, Jingyang ; Bai, Xiaochun ; Xie, Xiaoling ; Kuang, Zhanpeng ; Zhang, Yue ; Zhang, Sheng ; Gao, Xuefei ; Zeng, Hao ; Zou, Zhipeng ; Wei, Xiaocui ; Gong, Yan ; Jiang, Yuanjun ; Wei, Tiantian

Directed differentiation of stem cells toward chondrogenesis in vitro and in situ to regenerate cartilage suffers from off-target differentiation and hypertrophic tendency. Here, we generated a cartilaginous organoid system from human expanded pluripotent stem cells (hEPSCs) carrying a COL2A1^mCherry and COL10A1^eGFP double reporter, enabling real-time monitoring of chondrogenesis and hypertrophy. After screening 2,040 FDA-approved drugs, we found that α-adrenergic receptor (α-AR) antagonists, especially phentolamine, stimulated chondrogenesis but repressed hypertrophy, while α2-AR agonists reduced chondrogenesis and induced hypertrophy. Phentolamine prevented cartilage degeneration in hEPSC cartilaginous organoid and human cartilage explant models and stimulated microfracture-activated endogenous skeletal stem cells toward hyaline-like cartilage regeneration without fibrotic degeneration in situ. Mechanistically, α2-AR signaling induced hypertrophic degeneration via cyclic guanosine monophosphate (cGMP)-dependent secretory leukocyte protease inhibitor (SLPI) production. SLPI-deleted cartilaginous organoid was degeneration resistant, facilitating large cartilage defect healing. Ultimately, targeting α2-AR/SLPI was a promising and clinically feasible strategy to regenerate cartilage via promoting chondrogenesis and repressing hypertrophy.

2024-12-01·BEHAVIOURAL PHARMACOLOGY

The administration of a phentolamine infusion into the basolateral amygdala enhances long-term memory and diminishes anxiety-like behavior in stressed rats

Article

作者: Sahraei, Hedayat ; Meftahi, Gholam Hossein ; Dehghani, Ali

The basolateral amygdala (BLA) contains adrenergic receptors, which are known to be involved in stress, anxiety, and memory. The objective of this study was to explore whether inhibition of α-adrenergic receptors (by phentolamine, an α-adrenergic receptor antagonist) in the BLA can reduce foot-shock stress–induced anxiety-like behavior, memory deficits, and long-term potentiation (LTP) deficits within the CA1 region of the rat hippocampus. Forty male Wistar rats were assigned to the intact, control, stress (Str), Phent (phentolamine), and Phent + Str groups. Animals were subjected to six shocks on 4 consecutive days, and phentolamine was injected into BLA 20 min before the animals were placed in the foot-shock stress apparatus. Results from the elevated plus maze test (EPM) revealed a reduction in anxiety-like behaviors (by an increased number of entries into the open arm, percentage of time spent in the open arm, and rearing and freezing) among stressed animals upon receiving injections of phentolamine into the BLA. The open-field test results (increased rearing, grooming, and freezing behaviors) were consistent with the EPM test results. Phentolamine infusion into the BLA enhanced spatial memory, reducing errors in finding the target hole and decreasing latency time in the Barnes maze test for stress and nonstress conditions. Injecting phentolamine into the BLA on both sides effectively prevented LTP impairment in hippocampal CA1 neurons after being subjected to foot-shock stress. It has been suggested that phentolamine in the BLA can effectively improve anxiety-like behaviors and memory deficits induced by foot-shock stress.

2024-11-26·ENDOCRINOLOGY

Femoral Artery Infusion of αMSH Increases Muscle Thermogenesis and Promotes Glucose Uptake in Ovariectomized Ewes

Article

作者: Andrews, Zane B ; Clarke, Iain J ; Henry, Belinda A ; Cowley, Michael A

Abstract:

The melanocortin system is fundamental to neural control of energy balance and long-term weight regulation. Recent evidence shows that melanocortins also act at peripheral tissues to regulate metabolism, independent of the brain or the sympathetic nervous system (SNS). One such target is skeletal muscle, which contributes to energy expenditure through changes in adaptive thermogenesis. We aimed to determine 1) whether direct femoral infusion of α-melanocyte–stimulating hormone (αMSH) could increase muscle heat production independent of SNS activation and 2) if αMSH-induced skeletal muscle heat production was associated with altered mitochondrial function. Dataloggers were implanted into one hind leg of ovariectomized ewes and set to record vastus lateralis temperature every 15 minutes. A cannula was inserted into one femoral artery for infusion of either αMSH (0.1 µg/h) or saline. Femoral infusion of αMSH increased (P < .0001) skeletal muscle heat production, without effect on food intake. State 4 respiration increased (P < .05) and the respiratory control ratio decreased (P < .05) in mitochondria isolated from αMSH-treated animals. In addition, femoral infusion of αMSH reduced plasma glucose concentration in the femoral, but not the jugular vein; there was no effect of αMSH treatment on nonesterified fatty acid concentrations. These data suggest that αMSH can act locally to increase glucose uptake. We further show that blockade of the α- and β-adrenergic limbs of the SNS with either phentolamine or propranolol infusion had no effect on αMSH-induced skeletal muscle heat production. Overall, we show that αMSH acts directly at skeletal muscle to promote glucose uptake and increase energy expenditure via mitochondrial thermogenesis.

144

项与甲磺酸酚妥拉明相关的新闻（医药）

2024-12-03

·GlobeNewswire-Health Care

Opus Genetics to Host Virtual KOL Event on OPGx-LCA5 as a Treatment for LCA5-Associated Inherited Retinal Disease on December 11, 2024

6-month efficacy and safety data from ongoing Phase 1/2 trial of OPGx-LCA5 to be presentedFARMINGTON HILLS, Mich., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders, today announced that it will host a virtual key opinion leader (KOL) event on Wednesday, December 11, 2024 at 4:00 PM ET. To register, click here. The event will feature Jean Bennett, MD, PhD, and Tomas Aleman, MD, from the University of Pennsylvania, along with Christine Kay, MD, and Arshad Khanani, MD, MA, FASRS, who will discuss detailed, patient level 6-month efficacy and safety data on OPGx-LCA5, an adeno-associated virus (AAV)-based gene therapy, in Phase 1/2 development for LCA5-associated inherited retinal disease (IRD). The event will focus on the OPGx-LCA5 clinical data and will dive into the key efficacy assessments in detail. The presenters will also highlight the current unmet need with respect to LCA5-associated inherited retinal disease, next steps in the development program, and the potential of Opus Genetics’ therapeutic approach. A live question and answer session will follow the formal presentations. Jean Bennett, MD, PhD is the F.M. Kirby Emeritus Professor of Ophthalmology at the Perelman School of Medicine and continues to serve as director of the Center for Advanced Retinal and Ocular Therapeutics (CAROT) at the University of Pennsylvania. In addition to Dr. Bennett’s positions at the University of Pennsylvania, she has been an Investigator at the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia (CHOP) for more than a decade. She also co-founded life science companies Spark Therapeutics (acquired by Roche), GenSight Biologics and Limelight Bio. Dr. Bennett received her PhD in Zoology and Cell Biology from the University of California, Berkeley, and obtained her MD from Harvard University. She also completed postdoctoral fellowships in Radiobiology and Environmental Health at the University of California, San Francisco, Human Genetics at the Yale School of Medicine and Development Genetics at the Johns Hopkins University School of Medicine. She received her BS in Biology from Yale University. Tomas Aleman, MD is the Irene Heinz-Given and John LaPorte Research Professor at the Perelman School of Medicine, University of Pennsylvania. He is an Attending Physician in the Department of Ophthalmology at the Hospital of the University of Pennsylvania. He is part of the Retinal Degeneration Center at Scheie Eye Institute and the Center for Advanced Retinal & Ocular Therapeutics (CAROT), also at the University of Pennsylvania. Dr. Aleman has extensive expertise in the study of hereditary retinal degenerations. Most of the studies in which he has been investigator have aimed to lead patients with incurable retinal degenerations into clinical trials as well as in the detailed characterization of patients with these conditions. Dr. Aleman received an M.D. with High Honors from Sup de Cien Med de la Habana and completed a fellowship at the Scheie Eye Institute. Christine N. Kay, MD is a board-certified ophthalmologist and vitreoretinal surgeon and has been conducting clinical research since 2012. Her focus and passion are inherited retinal diseases, including but not limited to Stargardt disease, Retinitis Pigmentosa, and Achromatopsia. Dr. Kay is the Director of Research at Vitreoretinal Associates in Gainesville, Florida. She and her research team aim to improve the lives of people diagnosed with these and other diseases, as well as prevent blindness. Currently, the clinical trial team is conducting over 20 different studies targeting a multitude of retinal diseases. She was previously an Assistant Professor at the University of Florida and is currently Affiliate faculty at the University of South Florida. Dr. Kay is a member of the Macula Society, Retina Society, and American Society of Retina Specialists. Arshad M. Khanani, MD, MA, FASRS is the Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates, as well as a Clinical Professor at the University of Nevada, Reno School of Medicine. Dr. Khanani founded the clinical research department at Sierra Eye Associates, which has since become one of the nation's leading centers for clinical research. He has served as the principal investigator in over 120 clinical trials and has been a top enroller for several Phase 1-3 trials. He is also at the forefront of several collaborative studies examining real-world outcomes for newly approved treatments. Additionally, Dr. Khanani has been the first to perform surgical procedures in various clinical trials focused on sustained drug delivery and gene therapy. His extensive body of work includes numerous publications in highly regarded journals such as The Lancet, Ophthalmology, and JAMA Ophthalmology. Dr. Khanani is a lead principal investigator for several ongoing clinical trials and contributes to national and international clinical trial steering committees and scientific advisory boards. These efforts are aimed at developing new treatment options for patients with retinal diseases. A sought-after speaker, he is frequently invited to present at major national and international meetings. In 2021, Dr. Khanani founded the Clinical Trials at the Summit meeting to foster discussion on clinical trial design and data. Dr. Khanani is a distinguished member of both the Macula Society and the Retina Society, and he has earned various honors throughout his career. In 2019, he was named Healthcare Heroes Physician of the Year by Nevada Business Magazine for his dedication to ophthalmology. In 2023, he was chosen to deliver the prestigious Ernst Bodenheimer Memorial Lecture at the Wilmer Eye Institute, Johns Hopkins University. Dr. Khanani was also the recipient of the American Society of Retina Specialists (ASRS) Presidents’ Young Investigator Award in 2021 and the ASRS Presidential Award in 2024. About OPGx-LCA5 OPGx-LCA5 is designed to address a form of Leber congenital amaurosis (LCA) due to biallelic mutations in the LCA5 gene (LCA5), which encodes the lebercilin protein. LCA5-associated inherited retinal disease is an early-onset severe inherited retinal dystrophy. Studies in patients with this mutation have reported evidence for the dissociation of retinal architecture and visual function in this disease, suggesting an opportunity for therapeutic intervention through gene augmentation. OPGx-LCA5 uses an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5 gene to the outer retina. OPGx-LCA5 is currently being evaluated in a Phase 1/2 clinical trial at the University of Pennsylvania designed to evaluate its safety and preliminary efficacy in patients with inherited retinal degeneration due to biallelic mutations in the LCA5 gene. New 6-month efficacy and safety data on OPGx-LCA5 for treatment of LCA5-associated inherited retinal disease will be presented at a virtual KOL event on December 11, 2024. About Opus Genetics Opus Genetics is a clinical-stage ophthalmic biotechnology company developing gene therapies to treat patients with inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders. The pipeline includes adeno-associated virus (AAV)-based gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. The company’s most advanced gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial. BEST1 gene therapy is designed to address mutations in the BEST1 gene, which is associated with retinal degeneration; a Phase 1/2 study is expected to be initiated in 2025. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for presbyopia and dim (mesopic) light vision disturbances. For more information, please visit www.opusgtx.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning expectations regarding data from and future enrollment for our clinical trials and the effectiveness of our pipeline of indications and gene therapies. These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: Our ability to successfully integrate the business of former Opus Genetics Inc. and manage our expanded combined product pipeline;Our ability to develop and obtain regulatory approval for newly acquired gene therapies to treat inherited retinal diseases;Our ability to obtain and maintain orphan drug designation or rare pediatric disease designation for our current and future product candidates;The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;Regulatory requirements or developments;Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;Delays or difficulties in the enrollment of patients in clinical trials;Substantial competition;Rapid technological change;Our development of sales and marketing infrastructure;Future revenue losses and profitability;Changes in capital resource requirements;Risks related to our inability to obtain sufficient additional capital to continue to advance our product candidates and our preclinical programs;Domestic and worldwide legislative, regulatory, political and economic developments;Our dependency on key personnel;Changes in market opportunities and acceptance;Reliance on third parties to conduct our clinical trials and supply and manufacture drug supplies;Future, potential product liability and securities litigation;System failures, unplanned events, or cyber incidents;The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;Risks that our licensing or partnership arrangements may not facilitate the commercialization or market acceptance of our product candidates;Future fluctuations in the market price of our common stock;The success and timing of commercialization of any of our product candidates;Obtaining and maintaining our intellectual property rights; andThe success of mergers and acquisitions. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the SEC that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts CorporateInvestor RelationsNirav JhaveriCFOir@opusgtx.comCorey Davis, Ph.D.LifeSci Advisorscdavis@lifesciadvisors.com

临床3期

2024-12-02

·PRNewswire

Endo Launches ADRENALIN® Ready-to-Use Premixed Bag, the First and Only FDA-Approved, Manufacturer-Prepared Epinephrine Premixed IV Bag

MALVERN, Pa., Dec. 2, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of its ADRENALIN® (epinephrine in 0.9% sodium chloride injection) ready-to-use premixed bag, the first and only FDA-approved, manufacturer-prepared epinephrine premixed intravenous (IV) bag. "The first-ever ready-to-use epinephrine premixed bag represents an advancement for both providers and patients thanks to a delivery system that provides greater workflow efficiency, saves time, and reduces the risk of medication error," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions & Generics. "We are proud to provide critical care products like ADRENALIN® bags—ready when and where our customers need them—through our TruDelivery® portfolio." The ADRENALIN® premixed bag is the latest addition to Endo Injectable Solutions' TruDelivery® product line and platform. Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care. The ADRENALIN® premixed bag does not require compounding, diluting, mixing, or transferring, which may reduce waste. The single-port IV tubing reduces risk of inadvertently adding other medications to bag. The product also has a 24-month shelf life at room temperature. Endo also offers ADRENALIN® (epinephrine injection, USP) in 1 mL single-dose vials and 30 mL multi-dose vials. ADRENALIN® is used in the treatment of hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis. When Adrenalin is administered intravenously, check the infusion site frequently for free flow. Blanching along the course of the infused vein, sometimes without obvious extravasation, may be attributed to vasa vasorum constriction with increased permeability of the vein wall, permitting some leakage. This also may progress on rare occasions to superficial slough. Hence, if blanching occurs, consider changing the infusion site at intervals to allow the effects of local vasoconstriction to subside. There is potential for gangrene in a lower extremity when infusions of catecholamine are given in an ankle vein. Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent. Use a syringe with a fine hypodermic needle, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. ADVERSE REACTIONS: Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred. DRUG INTERACTIONS: Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, and ergot alkaloids. Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, catechol-O-methyltransferase (COMT) inhibitors, clonidine, doxapram, oxytocin, levothyroxine sodium, and certain antihistamines. Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, antihistamines, exogenous thyroid hormones, diuretics, cardiac glycosides, and quinidine. Observe for development of cardiac arrhythmias. Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine. USE IN SPECIFIC POPULATIONS: Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. INDICATION AND USAGE Hypotension associated with Septic Shock Adrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Click for Full Prescribing Information. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product launch, quality, efficacy, improved treatment, workflow efficiencies, reduced risks, waste or costs, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-11-14

·PRNewswire

Presbyopia Treatment Market Set to Reach New Heights with New Therapies and Advancements by 2034 | DelveInsight

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

临床3期上市批准临床2期

100 项与甲磺酸酚妥拉明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00509	甲磺酸酚妥拉明	V03AB36 C04AB01	DB00692

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
瞳孔散大	美国	Famy Life Sciences Pvt Ltd.	2023-09-25
勃起功能障碍	中国	上海复旦复华药业有限公司	1989-01-01
麻醉	美国	Novartis Pharmaceuticals Corp.	1952-01-30

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适应症	最高研发状态	国家/地区	公司	日期
夜盲症	临床3期	美国	Opus Genetics, Inc.	2023-04-27
老花眼	临床3期	美国	Opus Genetics, Inc.	2022-12-22
视力低下	临床3期	美国	Opus Genetics, Inc.	2020-12-30
开角型青光眼	临床2期	美国	Opus Genetics, Inc.	2019-05-28
失明	临床2期	美国	Opus Genetics, Inc.	2007-08-01

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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


NCT04620213 \| NCT05134974 (MIRA-3, Literature) 人工标引	临床3期	瞳孔散大	553	phentolamine	淵範選選憲糧鏇簾憲製(醖願顧網範鑰夢憲範獵) = 淵蓋壓築憲繭鹹鹹繭遞窪醖顧鏇網鏇簾鑰鹽衊 (遞窪構壓顧蓋鬱製獵築 )	积极	2024-09-16
				placebo	淵範選選憲糧鏇簾憲製(醖願顧網範鑰夢憲範獵) = 齋築餘膚淵鏇製網製遞窪醖顧鏇網鏇簾鑰鹽衊 (遞窪構壓顧蓋鬱製獵築 )
NCT04004507 (SNV, CTgov)	临床2期	夜盲症 \| 失明	24	Phentolamine Mesylate Ophthalmic Solution 1% (Phentolamine Mesylate Ophthalmic Solution 1%)	構製積範遞衊淵鏇壓憲(鹹衊夢鬱鑰鏇網艱繭觸) = 鬱壓壓鬱糧衊壓餘獵糧齋淵壓窪夢鏇簾鑰廠獵 (膚範衊構選夢網簾遞襯, 糧壓積鏇築築鬱襯鹽願 ~ 壓壓壓糧遞鑰鬱淵築醖) 更多	-	2024-02-15
				Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Phentolamine Mesylate Ophthalmic Solution Vehicle)	構製積範遞衊淵鏇壓憲(鹹衊夢鬱鑰鏇網艱繭觸) = 壓構壓繭願蓋蓋觸簾鏇齋淵壓窪夢鏇簾鑰廠獵 (膚範衊構選夢網簾遞襯, 夢蓋蓋餘壓膚醖餘艱夢 ~ 窪網鬱糧壓襯願構顧衊) 更多
NCT04620213 \| NCT05134974 (MIRA-3, FDA) 人工标引	临床3期	瞳孔散大	553	Ryzumvi (MIRA-2)	簾遞範構鏇繭遞淵繭鑰(糧艱鬱繭齋餘淵選襯選) = 蓋膚夢遞膚繭憲艱鹽醖願積積夢鹽齋鹹範繭鏇 (選醖製鬱鏇製窪觸夢膚 )	积极	2023-09-25
				Placebo (MIRA-2)	簾遞範構鏇繭遞淵繭鑰(糧艱鬱繭齋餘淵選襯選) = 鹹壓築憲鑰膚願構淵餘願積積夢鹽齋鹹範繭鏇 (選醖製鬱鏇製窪觸夢膚 )
NCT04620213 (MIRA-2, CTgov)	临床3期	瞳孔散大	185	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	襯遞獵鏇淵鑰廠鹹餘膚(願膚鬱膚膚鏇觸廠觸艱) = 範鏇鹹襯膚觸鏇夢淵繭簾壓範鹽願壓積網繭鹽 (遞夢範衊艱鹹鹽觸獵憲, 糧夢遞製艱構鑰繭衊壓 ~ 窪淵範壓積廠餘簾膚壓) 更多	-	2023-08-14
				Phentolamine Ophthalmic Solution Vehicle (Placebo) (Phentolamine Ophthalmic Solution Vehicle)	襯遞獵鏇淵鑰廠鹹餘膚(願膚鬱膚膚鏇觸廠觸艱) = 蓋觸鏇壓齋淵鏇積鹽憲簾壓範鹽願壓積網繭鹽 (遞夢範衊艱鹹鹽觸獵憲, 製艱遞醖願簾糧積膚製 ~ 窪廠製憲築淵淵淵積餘) 更多
NCT04638660 (LYNX-1, CTgov)	临床3期	视力低下	144	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	齋築鏇鹹網鏇餘遞窪獵(獵獵衊窪鹽築廠繭艱顧) = 艱淵獵壓範壓醖繭顧糧鹽願選鹹顧鏇網艱築願 (齋積網壓範顧夢鏇顧遞, 憲網簾願願廠淵淵鹹製 ~ 蓋鑰膚構築鑰餘膚獵範) 更多	-	2023-08-09
				Phentolamine Ophthalmic Solution Vehicle (Placebo) (Phentolamine Ophthalmic Solution Vehicle)	齋築鏇鹹網鏇餘遞窪獵(獵獵衊窪鹽築廠繭艱顧) = 網廠繭餘簾糧膚鬱繭艱鹽願選鹹顧鏇網艱築願 (齋積網壓範顧夢鏇顧遞, 齋遞觸淵製顧廠糧鏇壓 ~ 鹽窪鏇繭積鹽製糧繭蓋) 更多
NCT05223478 (MIRA-4, CTgov)	临床3期	瞳孔散大	23	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	淵遞襯壓獵壓艱遞窪襯(餘襯鏇襯鏇膚鹽顧餘構) = 顧觸鏇襯鏇齋壓憲夢膚襯鏇鏇鹽繭齋製顧鏇醖 (鬱淵醖醖鏇膚蓋壓範淵, 艱衊襯醖願構憲網鹹蓋 ~ 艱齋餘齋齋獵鑰襯鑰顧) 更多	-	2023-08-02
				Phentolamine Ophthalmic Solution Vehicle (Phentolamine Ophthalmic Solution Vehicle)	淵遞襯壓獵壓艱遞窪襯(餘襯鏇襯鏇膚鹽顧餘構) = 壓齋觸願遞網艱鏇製鏇襯鏇鏇鹽繭齋製顧鏇醖 (鬱淵醖醖鏇膚蓋壓範淵, 餘憲構觸廠鏇遞獵選襯 ~ 選網窪觸餘淵鹽顧醖網) 更多
NCT04675151 (CTgov)	临床2期	老花眼	150	LDP+POS (POS 0.75% First, Then LDP 0.4%)	夢獵鏇膚衊鬱選鹽壓顧(膚襯膚鹽網衊觸鑰夢衊) = 齋觸築網鏇遞夢築積獵範膚觸糧蓋積獵構艱夢 (鬱蓋製廠糧淵遞鑰衊窪, 鏇製願鑰網簾齋鑰鏇選 ~ 糧夢餘壓鬱製簾獵獵蓋) 更多	-	2023-08-02
				LDP+POS (POS 0.75% First, Then LDP Vehicle)	夢獵鏇膚衊鬱選鹽壓顧(膚襯膚鹽網衊觸鑰夢衊) = 選鹹糧築衊鹽窪觸衊繭範膚觸糧蓋積獵構艱夢 (鬱蓋製廠糧淵遞鑰衊窪, 齋膚繭壓鑰顧艱範蓋窪 ~ 鑰衊簾鹽積餘構築齋顧) 更多
NCT05134974 (MIRA-3, CTgov)	临床3期	瞳孔散大	368	Phentolamine Ophthalmic Solution 0.75% (Phentolamine Ophthalmic Solution 0.75%)	餘襯遞窪廠鑰淵糧艱範(製醖製夢鹽網憲繭膚齋) = 艱積鬱鏇構壓積構鏇鹹遞積壓壓顧鑰簾醖鬱遞 (鏇齋衊廠窪襯齋築鑰夢, 獵製構壓製鏇遞顧鬱憲 ~ 憲鹽鑰鏇製構觸壓窪鑰) 更多	-	2023-08-01
				Phentolamine Ophthalmic Solution Vehicle (Phentolamine Ophthalmic Solution Vehicle)	餘襯遞窪廠鑰淵糧艱範(製醖製夢鹽網憲繭膚齋) = 鹽齋衊餘選夢夢鹹鹹獵遞積壓壓顧鑰簾醖鬱遞 (鏇齋衊廠窪襯齋築鑰夢, 憲餘鹽鏇遞鑰膚艱膚夢 ~ 餘壓獵夢積膚膚積鏇鏇) 更多
NCT03960866 (ORION-1, CTgov)	临床2期	开角型青光眼	39	Phentolamine Mesylate Ophthalmic Solution 1% (Nyxol Ophthalmic Solution 1%)	夢選壓壓憲範構簾範鹹(築淵齋蓋蓋壓齋鏇憲齋) = 淵願選窪鑰鹽網觸鏇衊願淵鹽獵遞選齋窪鹹構 (積選窪遞顧夢遞鹹廠鬱, 鹹構範餘鏇窪窪夢鹹襯 ~ 顧鑰簾夢繭膚膚構蓋築) 更多	-	2023-07-12
				Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Nyxol Ophthalmic Solution Vehicle)	夢選壓壓憲範構簾範鹹(築淵齋蓋蓋壓齋鏇憲齋) = 遞築鬱構築顧夢遞艱鹽願淵鹽獵遞選齋窪鹹構 (積選窪遞顧夢遞鹹廠鬱, 鏇夢繭齋鏇餘遞選窪願 ~ 醖夢鏇艱衊窪鑰糧範膚) 更多
MIRA-2 and MIRA-3 (ARVO2023)	临床3期	瞳孔散大	-	Phentolamine Ophthalmic Solution	夢願蓋鏇窪齋繭壓遞餘(願選糧鹽廠醖築廠顧選) = 遞遞壓壓醖積壓獵簾醖範範廠簾窪夢襯鑰鑰獵 (鹹憲鬱壓網醖顧鏇網網 )	-	2023-06-01
				Placebo	夢願蓋鏇窪齋繭壓遞餘(願選糧鹽廠醖築廠顧選) = 齋艱構積壓觸簾顧憲醖範範廠簾窪夢襯鑰鑰獵 (鹹憲鬱壓網醖顧鏇網網 )