Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia With Chloroprocaine in Knee Arthroscopy: a Double-blind, Randomized, Controlled Trial

Chloroprocaine is a short-acting local anesthetic that allows rapid recovery and early ambulation but is currently recommended for procedures lasting 40 minutes or less.
Dexamethasone is commonly used during anesthesia for the prevention of postoperative nausea and vomiting and has also been shown to prolong the duration of analgesia and sensory block after regional anesthesia.
Dexamethasone may therefore extend the duration of chloroprocaine spinal anesthesia, potentially allowing its use for longer surgical procedures while maintaining the benefits of rapid postoperative recovery.
This study aims to evaluate whether intravenous dexamethasone can prolong the effects of spinal anesthesia performed with chloroprocaine in adults undergoing knee arthroscopy.

开始日期2026-09-01

申办/合作机构

Clinique Ambroise Paré SA

ChiCTR2600128154

/ Not yet recruitingN/AIIT

Effect of Throat Spray Chloroprocaine on Hemodynamics During Double-Lumen Tube Intubation in Patients With Hypertension: A Randomized Controlled Trial

开始日期2026-07-15

申办/合作机构

Liu'an People's Hospital

NCT07444827

/ Not yet recruiting临床4期IIT

Study of Targeted Injection of Nerves to the Knee-A Volunteer Trial Evaluating Nerve to Vastus Medialis

This randomized, double-blinded volunteer study compares two ways of performing the adductor canal (AC) nerve block at the mid-thigh to see which approach more reliably numbs the anteromedial knee. One approach is the traditional AC block placed near the saphenous nerve; the other separately targets the nerve to vastus medialis (NVM) in addition to the saphenous nerve. Healthy adult participants receive both blocks in one visit (one on each leg), with the order randomized. The primary outcome is change in quadriceps strength (a proxy for vastus medialis anesthesia) measured by load-cell dynamometry. Secondary outcomes include cutaneous sensory mapping (pinprick and cold) and the percentage of a standardized, marked knee-incision line covered by sensory block. The study uses ultrasound guidance and a standard dose of chloroprocaine, with routine monitoring to minimize risks.

开始日期2026-07-01

申办/合作机构

Duke University

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100 项与盐酸氯普鲁卡因相关的转化医学

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项与盐酸氯普鲁卡因相关的文献（医药）

2026-07-01·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Regional anesthesia in the emergency department: A review of key pharmacotherapeutic considerations

Review

作者: Gottlieb, Michael ; Riscinti, Matthew ; Rech, Megan A ; Ray, Lance ; Long, Brit

INTRODUCTION:

Opioid-associated risks and the opioid epidemic have accelerated interest in multimodal analgesia in the emergency department (ED). Regional anesthesia offers a targeted approach with reduced risk of systemic adverse effects and is increasingly used under ultrasound guidance.

OBJECTIVE:

This concise, evidence-based review explores pharmacological principles of local anesthetics describing key aspects of structure-activity relationship, providing context for agent selection. Additional considerations include dosing strategy, adjunctive medications, potential risks, toxicity mitigation, and operationalization of regional anesthesia in the ED.

DISCUSSION:

Regional anesthesia is used with increased frequency in the ED. Pharmacologic properties of commonly used local anesthetics and adjunctive agents determine their advantages and limitations as well as place in therapy. There are a variety of anesthetic agents, including amides (e.g., lidocaine, bupivacaine, ropivacaine, levobupivacaine) and esters (e.g., articaine, chloroprocaine) with differences in onset, duration, and toxicity profiles that influence agent selection in ED patient populations. Adjuncts such as epinephrine, dexamethasone, and alpha-2 agonists may extend nerve block duration or improve analgesia but introduce safety and operational considerations. Recognition of local anesthetic systemic toxicity (LAST) remains central to safe practice, underscoring the importance of weight-based dosing, ultrasound guidance, monitoring, and immediate access to lipid emulsion therapy. Systems-based approaches such as order sets, pharmacist involvement, and structured training support consistent and safe application of regional anesthesia in the ED setting.

CONCLUSIONS:

Safe integration of regional anesthesia in the ED requires pharmacologic literacy, standardized systems, and multidisciplinary support to optimize analgesia while minimizing risk.

2026-05-01·INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA

Stability of the pH of local anesthetics after bicarbonation: an electrochemical assay of clinical mixtures

Article

作者: Li, Yunping ; Hess, Philip E ; Ciampa, Erin J ; Armstrong, Samantha L

BACKGROUND:

Raising the pH of local anesthetics shortens their time to onset, and this is commonly done in clinical practice via addition of sodium bicarbonate. A prior study found that the pH of local anesthetics decreases over time after a factory-sealed vial has been opened, presumably due to hydrolysis of atmospheric carbon dioxide. We hypothesized that the alkalinization effect achieved by adding bicarbonate to local anesthetics may similarly be unstable, potentially affecting the drug's time-to-onset if not used immediately.

METHODS:

We prepared solutions of chloroprocaine 3% and lidocaine 2% each buffered with sodium bicarbonate 1 M at a 10:1 vol ratio. Mixtures were stored at room temperature, and to assess the effects of atmospheric exposure, we compared syringes sealed with a rubber cap versus a blunt needle. We recorded electrochemical pH measurements at timepoints of 0, 1, 2, 4, 6, 12, and 24 h.

RESULTS:

Adding bicarbonate to lidocaine raised pH from 6.5 ± 0.02 to 7.4 ± 0.04. Adding bicarbonate to chloroprocaine raised pH from 3.5 ± 0.03 to 7.6 ± 0.03. We found that the pH of each bicarbonated local anesthetic solution was stable to within 0.2 pH units across 24 h, regardless of type of seal.

CONCLUSIONS:

These findings indicate that the faster onset time achieved by adding bicarbonate is likely to be preserved for at least 24 h when these solutions are stored in a syringe at room temperature. From the standpoint of pH stability, these findings support the practice of preparing buffered local anesthetic mixtures before they are needed, in order to minimize delay of administration (as for emergency indications); however, safety standards for drug compounding and storage must always guide practice.

2026-03-01·REGIONAL ANESTHESIA AND PAIN MEDICINE

Comparison of 1% chloroprocaine hydrochloride versus hyperbaric bupivacaine spinal in patients undergoing anorectal surgery in an ambulatory surgery center: a double-blind randomized clinical trial

Article

作者: Iyabo O Muse ; Jashvin Patel ; Elilary Montilla Medrano ; Curtis Choice ; Timothy Pulverenti ; Seung W Kim ; Rebecca Levine ; Mikhail Goman ; Chandrappa P Balikai ; Rafi Khandaker ; Adam Yedlin

Background:

Preservative-free chloroprocaine is a promising spinal anesthetic for ambulatory surgeries, offering a short duration of action and minimal side effects, which promote faster recovery and discharge. Thus, this study aimed to compare chloroprocaine hydrochloride to the widely used bupivacaine as a spinal anesthetic in ambulatory anorectal surgeries. We hypothesized that chloroprocaine will lead to quicker recovery and discharge, supporting its use in the ambulatory surgical setting.

Methods:

In this double-blind randomized controlled trial, 110 patients were randomized to 1% chloroprocaine or 0.75% bupivacaine treatment groups. Due to the inability to place a spinal anesthetic, five patients were excluded (one in chloroprocaine and four in bupivacaine groups). The co-primary endpoints were recovery time (defined as the time of motor and sensory function return), and time discharge criteria were met. The secondary endpoint was the onset of transient neurological symptoms (TNS).

Results:

The chloroprocaine group had a significantly shorter time to meet discharge criteria (191.4±6.6 min) than the bupivacaine group (230.9±9.4 min; p=<0.001). There were no significant differences between interventions for recovery time. No TNS were recorded within 24 hours after the procedure for both groups.

Conclusion:

Our study demonstrated a significantly reduced time to meeting discharge criteria with chloroprocaine compared with bupivacaine without an increased risk of TNS. Our results support the use of chloroprocaine for spinal anesthesia in ambulatory anorectal surgeries.

Trial registration number:

NCT03324984 .

项与盐酸氯普鲁卡因相关的新闻（医药）

2026-08-20

·BioSpace

Harrow Announces IHEEZO® Data in Patient-Reported Discomfort Following Intravitreal Injections

Patients reported approximately 58% less discomfort overall in the IHEEZO-treated eye, with the largest absolute differences in the immediate post-injection period, when discomfort is highest NASHVILLE, Tenn., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced positive results from a prospective, randomized, contralateral-eye study evaluating IHEEZO ® (chloroprocaine hydrochloride ophthalmic gel) 3%, an ophthalmic gel indicated for ocular surface anesthesia, in patients undergoing same-day bilateral intravitreal injections. The single-center, investigator-initiated study demonstrated statistically significant differences favoring IHEEZO at every measured time point. Patients reported approximately 58% less discomfort overall in the IHEEZO-treated eye than in the fellow eye treated with proparacaine ophthalmic solution 0.5%, a statistically significant difference at all four post-injection assessments (all p≤0.048). The largest absolute treatment differences were observed immediately after injection, when discomfort is highest: 1.44 versus 3.06 at two minutes and 1.26 versus 2.82 at one hour, while lower discomfort scores with IHEEZO remained evident through the 24-hour assessment. Millions i of intravitreal injections are performed in the United States each year — making them among the most frequently performed procedures in ophthalmology — and they are often administered repeatedly over months or years to patients with retinal diseases. As a result, the injection experience, including patient discomfort, can become an important consideration for both patients and retina specialists, particularly in practices managing a high volume of patients who return regularly for treatment. Study Results IHEEZO was associated with lower patient-reported discomfort at all four post-injection assessments, measured using a standard 0-to-10 numeric rating scale: The results showed a consistent benefit with IHEEZO throughout the 24-hour assessment period, with lower patient-reported discomfort at every time point. The largest absolute differences occurred shortly after injection, when discomfort is highest. Absolute treatment differences were 1.62 points at two minutes and 1.56 points at one hour, and lower discomfort scores with IHEEZO remained evident through the 24-hour assessment. “Patient comfort is a larger part of the intravitreal injection experience than it is sometimes given credit for,” said Travis Peck, MD, Retina Consultants of Delmarva, principal investigator of the study. “Because each patient received both anesthetic approaches on the same day, we were able to directly compare the patient experience. Patients consistently reported less discomfort in the IHEEZO-treated eye across all time points we measured. For retina specialists who perform a high volume of injections and care for patients who return repeatedly for treatment, these are practical and clinically relevant findings.” “These results provide new clinical evidence from a real-world practice setting supporting IHEEZO’s differentiated clinical pro commonly administered legacy ophthalmic anesthesia modalities – demonstrating a measurable improvement in patient-reported comfort following intravitreal injections,” said Mark L. Baum, Chief Executive Officer of Harrow. “Retina specialists work to preserve vision in patients who require ongoing treatment over many years, and the experience of each of those visits matters and ideally, should be optimized. The consistency and magnitude of the reduction in patient discomfort should strengthen physician confidence in IHEEZO’s clinical pro support broader utilization of the product across retina practices.” About the Study The investigator-initiated study was a prospective, randomized, contralateral-eye comparison conducted in a private retina practice. The study evaluated 100 eyes from 50 adult patients undergoing same-day bilateral intravitreal injections. Both eyes received 2% lidocaine-soaked pledgets prior to administration of the randomized study anesthetic. In each patient, one randomly assigned eye received IHEEZO prior to injection and the fellow eye received preservative-containing proparacaine ophthalmic solution 0.5%, allowing each patient to serve as his or her own control and reducing between-patient variability. Patient-reported ocular discomfort was assessed using a 0-to-10 numeric rating scale at 2 minutes, 1 hour, 6–12 hours, and 24 hours following injection. IHEEZO ® (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use INDICATIONS AND USAGE IHEEZO is an ester anesthetic indicated for ocular surface anesthesia. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation WARNINGS AND PRECAUTIONS Not for Injection or Intraocular Administration Corneal Injury Due to Insensitivity Corneal Opacification For Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) Please see full  Prescribing information About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts : Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 i Comparative incidence of endophthalmitis after intravitreal dexamethasone implant versus anti-VEGF injections: a retrospective study. International Journal of Retina and Vitreous. 2026 A photo accompanying this announcement is available at

2026-07-20

·BioSpace

Harrow Highlights Growing Clinical Evidence Supporting IHEEZO® and BYOOVIZ® at ASRS 2026 Annual Meeting

NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the presentation of three studies supporting IHEEZO ® (chloroprocaine HCl ophthalmic gel 3%), a broadly labeled low viscosity ocular anesthetic gel, and BYOOVIZ ® (ranibizumab-nuna) i , an FDA-approved biosimilar referencing LUCENTIS ii (ranibizumab) at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting. Collectively, the presentations expand the growing body of clinical and real-world evidence supporting Harrow's retina portfolio and reinforce Harrow’s commitment to generating quality evidence that strengthens physician confidence, improves patient experience, and supports long-term product adoption and innovation. “ASRS is one of the premier scientific meetings in retina, and we're excited to share data that continues to strengthen the foundation supporting our growing retina franchise,” said Mark L. Baum, Chief Executive Officer of Harrow. “We believe durable commercial success is built on strong clinical evidence, generated before FDA-approval, and then robust supportive data sets subsequently produced. These studies further expand the evidence supporting IHEEZO while adding to the growing body of real-world experience for BYOOVIZ, reflecting our long-term commitment to retina specialists and the patients they treat.” One presentation highlighted interim findings from an investigator-initiated, prospective, randomized study of 150 patients comparing IHEEZO versus subconjunctival lidocaine. While these preliminary data represent an early look at the data, investigators observed encouraging trends toward less post-procedure pain, a better post-injection patient experience, and fewer ocular symptoms through 24 hours following intravitreal injection among patients treated with IHEEZO. Harrow believes these early findings provide an encouraging signal supporting further investigation in a larger patient population. Importantly, Harrow continues to enroll QUELL, a prospective, randomized, multi-center clinical trial of approximately 236 subjects that is being conducted under an active Investigational New Drug (IND) application. QUELL is designed to generate robust clinical evidence evaluating post-injection pain, patient experience, procedural performance, and safety in a substantially larger patient population, with topline data expected in the fourth quarter of 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Another real-world study retrospectively evaluated whether IHEEZO's proprietary low-viscosity gel formulation interferes with antisepsis when used with chlorhexidine before intravitreal injection. Across nearly 20,000 injections, investigators observed no evidence of an increased endophthalmitis risk compared with a legacy tetracaine/povidone-iodine preparation. Although retrospective and not intended to demonstrate statistical superiority, the findings provide further confidence that physicians can realize the patient-experience benefits of IHEEZO's low-viscosity gel formulation without introducing additional procedural risk associated with antisepsis. “These studies help build the scientific foundation supporting IHEEZO,” said Amir Shojaei, Chief Scientific Officer of Harrow. “The early interim randomized data suggest the potential to improve the patient experience, while the large real-world analysis provides reassuring evidence regarding procedural safety. We look forward to completing enrollment in QUELL, which we believe will provide the most comprehensive evaluation of IHEEZO in retina to date.” Finally, Samsung Bioepis presented interim findings from a large-scale, real-world post-marketing surveillance study of BYOOVIZ. Full results from this study are being announced jointly with Samsung Bioepis today. “Between the continued expansion of the clinical evidence supporting IHEEZO, the recent launch of BYOOVIZ, and the ongoing growth of our retina franchise, we believe Harrow is increasingly well-positioned as a trusted long-term partner to retina specialists,” Baum concluded. “We appreciated the opportunity to engage with physicians throughout ASRS and look forward to sharing additional updates later this year.” IHEEZO ® (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use INDICATIONS AND USAGE IHEEZO is an ester anesthetic indicated for ocular surface anesthesia. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation WARNINGS AND PRECATIONS Not for Injection or Intraocular Administration. Corneal Injury Due to Insensitivity. Corneal Opacification For Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) Please see full Prescribing information BYOOVIZ ® (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) INDICATIONS AND USAGE BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP Please see full Prescribing Information About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts: Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 i Byooviz is a trademark of Samsung Bioepis Co., Ltd. ii Lucentis is a trademark of Genentech, Inc.

临床结果

2026-07-01

·BioSpace

Harrow Announces Commercial Launch of BYOOVIZ® in the United States

Expands Harrow's Growing Retina Portfolio with an Interchangeable Ranibizumab Biosimilar NASHVILLE, Tenn., July 01, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the commercial launch of BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS i (ranibizumab) and developed by Samsung Bioepis Co., Ltd. The launch follows Harrow's exclusive U.S. commercialization agreement with Samsung Bioepis, one of the world's leading biosimilar developers and manufacturers. Through this partnership, Harrow obtained exclusive U.S. rights to commercialize BYOOVIZ and OPUVIZ® (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEA ii (aflibercept), further strengthening the Company's position in the rapidly growing retinal biologics market. BYOOVIZ was approved by the U.S. Food and Drug Administration (FDA) as the first ophthalmology biosimilar in the U.S. for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). As an FDA-designated interchangeable biosimilar to LUCENTIS, BYOOVIZ provides retina specialists with a clinically proven anti-VEGF therapy that offers confidence, flexibility, and choice in patient care. The launch of BYOOVIZ marks another important step in the evolution of Harrow's market-leading retina franchise. With an estimated $9 billion U.S. anti-VEGF market iii and increasing demand for therapies that treat sight-threatening retinal diseases, Harrow continues to build a differentiated portfolio of buy-and-bill products designed specifically for the needs of retina specialists and the patients they serve. BYOOVIZ joins Harrow's expanding retina franchise, which includes IHEEZO® (chloroprocaine hydrochloride 3% ophthalmic gel), a branded FDA-approved ocular anesthetic indicated for ocular surface anesthesia that is increasingly utilized by retina specialists during intravitreal injection procedures, and TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/ml, a high-trust preservative-free injectable corticosteroid, broadly labeled and increasingly used by retina specialists nationwide. Together, these products enable Harrow to support both the procedural and therapeutic aspects of retinal disease management, providing retina practices with a trusted commercial partner across multiple points of care. "BYOOVIZ is far more than a product launch—it underscores Harrow's commitment to the U.S. retina community," said Mark L. Baum, Founder, Chairman, and Chief Executive Officer of Harrow. "Over the past several years, we have earned the trust of physicians through products like IHEEZO and TRIESENCE—products a growing number of retina specialists have integrated into their procedural workflows—supported by one of the most experienced and tenured retina teams in the industry. The investments we’ve made in our commercial infrastructure are specifically designed to serve retina specialists, and we intend to keep investing in and growing our retina franchise for years to come. With BYOOVIZ, we will bring our customers an interchangeable ranibizumab biosimilar to a market increasingly focused on both clinical confidence and economic value. Together with exclusive commercialization rights to OPUVIZ in the US, we believe we are creating one of the most compelling retina portfolios in ophthalmology." “The introduction of BYOOVIZ gives retina specialists another valuable treatment option for our patients,” said Samuel A. Minaker, M.D., vitreoretinal surgeon, Director of Clinical Research at Tyler Retina Consultants. “Many of my patients are treated with LUCENTIS or a LUCENTIS-referenced biosimilar; however, we have found that access to supply has not always been assured, with products coming in and out of availability more recently. What gives me additional confidence in BYOOVIZ is its interchangeability designation, supported by data showing no clinically meaningful differences between the biosimilar and reference product when patients switch between therapies. Just as importantly, it's exciting to see this product return to the market through a commercial partner like Harrow that has already earned credibility in my practice and within the retina community. Harrow understands the needs of retina practices, has demonstrated a commitment to supporting physicians and patients, and brings a level of confidence that makes BYOOVIZ a welcome addition to the treatment options available for my patients.” “I’ve had the opportunity to work with Harrow on several ophthalmic products,” said Seenu M. Hariprasad, M.D., Chair of Ophthalmology and Visual Science, Chief of Vitreoretinal Service, and Shui-Chin Lee Professor of Ophthalmology and Visual Science at the University of Chicago Medicine. “I first worked with Harrow through IHEEZO, which helped improve the patient experience during intravitreal injection procedures, and later with TRIESENCE, an important treatment option for many patients. Throughout that time, their team has demonstrated an understanding of the clinical, operational, and economic realities retina specialists face every day. Adding BYOOVIZ to their portfolio is a natural extension of that experience. Having access to a trusted ranibizumab biosimilar from a company with experience supporting retina specialists makes BYOOVIZ a welcome addition to the treatment options available for patients.” Physician Prescribing Information Healthcare providers interested in prescribing BYOOVIZ (ranibizumab-nuna) for their patients can access prescribing information, patient support resources, and ordering details by visiting or by calling 1-833-4HARROW (442-7769). BYOOVIZ® (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) INDICATIONS AND USAGE BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Hypersensitivity WARNINGS AND PRECATIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP Please see full Prescribing information OPUVIZ ® (aflibercept-yszy) injection, for intravitreal use is a biosimilar to EYLEA (aflibercept) INDICATIONS AND USAGE OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Active intraocular inflammation Hypersensitivity WARNINGS AND PRECATIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see full Prescribing information IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, for topical ophthalmic use INDICATIONS AND USAGE IHEEZO is an ester anesthetic indicated for ocular surface anesthesia. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation WARNINGS AND PRECATIONS Not for Injection or Intraocular Administration. Corneal Injury Due to Insensitivity. Corneal Opacification For Administration by Healthcare Provider: IHEEZO is not intended for patient self-administration ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) Please see full Prescribing information TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL INDICATIONS AND USAGE TRIESENCE® Suspension is indicated for: Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Visualization during vitrectomy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS TRIESENCE® Suspension is contraindicated in patients with systemic fungal infections. TRIESENCE® Suspension is also contraindicated in patients with hypersensitivity to corticosteroids or any component of TRIESENCE® Suspension. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. WARNINGS AND PRECATIONS TRIESENCE® is a suspension; it should not be administered intravenously. Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and hyperglycemia: Monitor patients for these conditions and taper doses gradually. Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection. Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels. GI perforation: Increased risk in patients with certain GI disorders. Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Decreases in bone density: Monitor bone density in patients receiving long term corticosteroid therapy. Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids. Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy. Use in pregnancy: Fetal harm can occur with first trimester use. Weight gain: May cause increased appetite. ADVERSE REACTIONS Based on a review of the available literature, the most commonly reported adverse events following ocular administration of triamcinolone acetonide were elevated intraocular pressure and cataract progression. These events have been reported to occur in 20-60% of patients. Less common reactions occurring in up to 2% of patients include: endophthalmitis (infectious and non-infectious), hypopyon, injection site reactions (described as blurring and transient discomfort), glaucoma, vitreous floaters, detachment of retinal pigment epithelium, optic disc vascular disorder, eye inflammation, conjunctival hemorrhage and visual acuity reduced. Cases of exophthalmos have also been reported. Please see full Prescribing information About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology. For more information, please visit and follow us on LinkedIn and X . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Contacts: Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc iii Emergen Research, U.S. Anti-VEGF Market Size, Growth Outlook 2034

上市批准引进/卖出

100 项与盐酸氯普鲁卡因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00732	盐酸氯普鲁卡因	N01BA04	DB01161

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
麻醉	美国	Fresenius Kabi USA LLC	1955-03-11
神经阻滞	美国	Fresenius Kabi USA LLC	1955-03-11
组织浸润	美国	Fresenius Kabi USA LLC	1955-03-11

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
眼部疾病	申请上市	加拿大	Apotex, Inc.	2025-02-01
白内障	临床3期	意大利	Sintetica SA	2020-09-09
白内障	临床3期	斯洛伐克	Sintetica SA	2020-09-09
白内障	临床3期	西班牙	Sintetica SA	2020-09-09
镇痛	临床3期	比利时	Sintetica SA	2016-10-01
扁平足	临床2期	意大利	Sintetica SA	2019-02-14
扁平足	临床2期	西班牙	Sintetica SA	2019-02-14
腹股沟疝	临床2期	意大利	Sintetica SA	2019-02-14
腹股沟疝	临床2期	西班牙	Sintetica SA	2019-02-14

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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


NCT05926258 (CTgov)	临床3期	麻醉	74	Chloroprocaine 3% eye gel (Chloroprocaine 3% Gel)	鏇簾範願遞鏇鹹鏇選廠 = 衊衊製齋範衊夢廠製鏇網選鑰獵繭艱窪廠積糧 (積鬱鹽壓衊夢淵製餘衊, 齋壓糧餘廠醖鹹製淵鏇 ~ 繭顧餘鏇顧艱艱繭獵壓) 更多	-	2026-03-09
				Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops (Oxybuprocaine 0,4% Solution)	鏇簾範願遞鏇鹹鏇選廠 = 鏇選築製鏇鏇淵築壓簾網選鑰獵繭艱窪廠積糧 (積鬱鹽壓衊夢淵製餘衊, 鹽襯艱鏇顧齋衊顧糧艱 ~ 鬱構顧淵憲獵窪餘築糧) 更多
NCT03324984 (CTgov)	临床2期	麻醉	110	1% chloroprocaine (1% Chloroprocaine (PF))	鏇製齋簾構積齋鹹繭艱(憲憲夢鏇鏇鏇餘獵膚壓) = 獵夢遞醖鏇糧繭齋窪襯觸積蓋鏇繭鏇構鹹遞繭 (襯蓋範築膚膚鏇鏇膚淵, 8.6) 更多	-	2025-02-28
				bupivacaine (0.75% Bupivacaine)	鏇製齋簾構積齋鹹繭艱(憲憲夢鏇鏇鏇餘獵膚壓) = 廠鏇壓簾窪糧觸鏇糧膚觸積蓋鏇繭鏇構鹹遞繭 (襯蓋範築膚膚鏇鏇膚淵, 10.3) 更多
NCT03324984 (Pubmed \| Reg Anesth Pain Med)	临床2期	直肠疾病	110	1% Chloroprocaine Hydrochloride	鬱糧獵窪觸鹹衊襯顧醖(顧觸範膚窪窪繭淵齋廠) = 選簾廠夢積鑰範繭齋衊襯膚衊窪夢糧餘餘淵築 (鏇範餘醖鹽顧獵繭範醖, 6.6)	积极	2024-12-31
				0.75% Bupivacaine	鬱糧獵窪觸鹹衊襯顧醖(顧觸範膚窪窪繭淵齋廠) = 壓鏇顧壓簾艱糧淵觸淵襯膚衊窪夢糧餘餘淵築 (鏇範餘醖鹽顧獵繭範醖, 9.4)
NCT03760718 (CLOR-PRO, CTgov)	早期临床1期	-	15	Preservative free 1% Chloroprocaine (Preservative Free Chloroprocaine Group 1)	遞鏇廠築憲鑰顧築鏇夢(繭積鏇窪齋鏇鑰餘範鑰) = 夢築鹹艱艱鬱選壓網鬱願衊範簾夢醖蓋憲夢鏇 (醖遞構鑰齋鏇鹹範夢網, 獵襯齋蓋醖鑰遞鹹淵齋 ~ 窪鬱鏇蓋範選淵觸觸遞) 更多	-	2024-09-19
				Chloroprocaine (Preservative Free Chloroprocaine Group 2)	遞鏇廠築憲鑰顧築鏇夢(繭積鏇窪齋鏇鑰餘範鑰) = 繭糧壓淵願積醖積範醖願衊範簾夢醖蓋憲夢鏇 (醖遞構鑰齋鏇鹹範夢網, 鏇網艱繭蓋獵膚衊獵顧 ~ 糧齋製淵鹽獵積觸衊夢) 更多
NCT04685538 (Pubmed \| J Ocul Pharmacol Ther) 人工标引	临床3期	白内障	338	Chloroprocaine 3% gel	繭獵遞廠選窪製衊廠壓(衊鹽選壓網選窪鏇鏇鏇) = 構齋構構醖製艱鹹餘衊簾窪網獵鏇顧壓鹽選鏇 (繭餘顧顧遞襯鬱壓夢鹽 ) 更多	积极	2024-03-01
				Tetracaine 0.5% eye drops	繭獵遞廠選窪製衊廠壓(衊鹽選壓網選窪鏇鏇鏇) = 構鏇鹹顧壓構鏇範艱窪簾窪網獵鏇顧壓鹽選鏇 (繭餘顧顧遞襯鬱壓夢鹽 ) 更多
NCT02919072 (CTgov)	临床3期	疼痛 \| 镇痛	16	Chloroprocaine (Chloroprocaine)	壓鏇壓衊鏇衊觸醖餘鏇(醖鑰襯餘繭衊網顧蓋艱) = 遞積鬱憲壓願蓋築積壓衊憲齋夢選夢遞選膚鬱 (壓選願衊窪醖鬱願齋顧, 5.8) 更多	-	2023-11-21
				Ropivacaine (Ropivacaine)	壓鏇壓衊鏇衊觸醖餘鏇(醖鑰襯餘繭衊網顧蓋艱) = 鬱顧襯構餘淵糧網獵構衊憲齋夢選夢遞選膚鬱 (壓選願衊窪醖鬱願齋顧, 4) 更多
NCT04369950 (Pubmed \| Anesth Analg)	N/A	术后疼痛	40	2% lidocaine with 1:200,000 epinephrine and sodium bicarbonate	鹽憲鬱繭鹽遞廠壓餘襯(觸衊獵範蓋鏇簾獵廠積) = 衊鹹範觸製齋壓鹽衊餘襯糧繭壓蓋網獵觸夢範 (廠鹽製壓醖製繭壓壓壓, 6.3 ~ 22.5)	-	2023-01-01
NCT04685538 (CTgov)	临床3期	白内障	338	Chloroprocaine 3% (Chloroprocaine 3%)	網遞範鑰鹹夢膚鏇窪觸 = 構鹹鏇築鏇艱廠積齋繭鹽糧製鏇鑰築願艱醖餘 (選夢艱網獵鹹觸廠蓋網, 憲鬱膚積繭鬱簾範鑰膚 ~ 築鑰積糧顧築積築範觸) 更多	-	2022-10-27
				Tetracaine 0.5% (Tetracaine 0.5%)	網遞範鑰鹹夢膚鏇窪觸 = 鹽廠醖製獵顧繭鏇蓋餘鹽糧製鏇鑰築願艱醖餘 (選夢艱網獵鹹觸廠蓋網, 範膚艱願鏇膚鏇簾範憲 ~ 餘鑰鹽築積獵憲簾網鹽) 更多
NCT03760718 (Pubmed \| Anesth Analg)	早期临床1期	-	-	1% Chloroprocaine solution	艱築鑰顧齋積選襯鬱窪(鹹餘範衊網簾膚積簾繭) = 鏇壓窪壓窪餘餘築艱觸構襯構觸襯範糧廠鏇積 (遞獵蓋鏇鹹鑰鬱鹹餘糧 )	积极	2022-10-01
				2% Chloroprocaine solution	艱築鑰顧齋積選襯鬱窪(鹹餘範衊網簾膚積簾繭) = 遞淵齋鏇蓋鬱鹽鏇願遞構襯構觸襯範糧廠鏇積 (遞獵蓋鏇鹹鑰鬱鹹餘糧 )
NCT01719237 (CTgov)	临床4期	疼痛	60	Ropivacaine+Cholroprocaine (Ropivacaine and Cholroprocaine Mixture)	積鬱鬱鑰窪範艱鹽選夢(觸製淵醖積鹹築膚膚衊) = 蓋餘簾網鏇淵積餘鑰糧顧鏇積鹹願艱獵獵願糧 (衊淵積衊選範遞襯壓蓋, 蓋選鹽積獵鹽選鹹鬱製 ~ 糧製糧築糧鬱築襯餘願) 更多	-	2022-09-14
				Ropivacaine (Ropivacaine Only)	積鬱鬱鑰窪範艱鹽選夢(觸製淵醖積鹹築膚膚衊) = 製網製構遞製蓋積衊憲顧鏇積鹹願艱獵獵願糧 (衊淵積衊選範遞襯壓蓋, 範鹹築願壓積艱襯鹹簾 ~ 淵艱餘餘繭鹹膚壓觸廠) 更多