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Last update 09 Jul 2026

Chloroprocaine Hydrochloride

Last update 09 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

2-chloroprocaine, 4-amino-2-chlorobenzoic acid 2-(diethylamino)ethyl ester, Ampres

+ [12]

Target

Sodium channels

Action

blockers

Mechanism

Sodium channels blockers

Therapeutic Areas

Nervous System DiseasesOther DiseasesEye Diseases+ [2]

Active Indication

Eye DiseasesAnesthesiaNeurolytic Block+ [3]

Inactive Indication

AnalgesiaCataract

Originator Organization

Fresenius Kabi AG

Active Organization

Fresenius Kabi USA LLC

B. Braun Melsungen AG

Sintetica SA

+ [3]

Inactive Organization

B. Braun Medical, Inc.

License Organization

Apotex, Inc.

Harrow, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (11 Mar 1955),

AnesthesiaNeurolytic BlockTissue infiltration

Regulation-

Structure/Sequence

Molecular FormulaC13H20Cl2N2O2

InChIKeySZKQYDBPUCZLRX-UHFFFAOYSA-N

CAS Registry3858-89-7

103

Clinical Trials associated with Chloroprocaine Hydrochloride

NCT07674576

/ Not yet recruitingPhase 3

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.

Start Date01 Sep 2026

Sponsor / Collaborator

Clinique Ambroise Paré SA

NCT07444827

/ Not yet recruitingPhase 4IIT

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.

Start Date01 Jul 2026

Sponsor / Collaborator

Duke University

NCT07348614

/ RecruitingPhase 4IIT

Flex Appeal: A Prospective Randomized Controlled Trial Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia (MUA)

The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.

Start Date01 Jun 2026

Sponsor / Collaborator

Duke University

100 Clinical Results associated with Chloroprocaine Hydrochloride

100 Translational Medicine associated with Chloroprocaine Hydrochloride

100 Patents (Medical) associated with Chloroprocaine Hydrochloride

534

Literatures (Medical) associated with Chloroprocaine Hydrochloride

01 Jul 2026·AMERICAN JOURNAL OF EMERGENCY MEDICINE

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

Review

Author: 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.

01 May 2026·INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA

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

Article

Author: 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.

01 Mar 2026·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

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

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 .

News (Medical) associated with Chloroprocaine Hydrochloride

01 Jul 2026

·www.biospace.com

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

Drug ApprovalLicense out/in

26 May 2026

·www.prnewswire.com

Apotex expands ophthalmic portfolio with Health Canada approval of IHEEZO™

TORONTO, May 26, 2026 /PRNewswire/ - Apotex Inc. ("Apotex" or the "Company"), the largest Canadian‑based pharmaceutical company, today announced that Health Canada has approved IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel 3%), a topical ophthalmic anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures in adults.[1] With approval granted, IHEEZO™ will be available to Canadian healthcare professionals as a sterile, preservative‑free gel formulation supplied in single‑use vials. IHEEZO™ is intended for administration by qualified eye care clinicians only and is not for patient self‑administration. "This approval reflects our commitment to supporting Canadian healthcare professionals with high‑quality medicines that meet important clinical needs," said Martin Arès, President, Apotex Canada and Rest of World (ROW). "Ocular care is an essential area of clinical practice, and we are proud to introduce IHEEZO™ as another approved option within our ophthalmic portfolio, alongside Verkazia®, Clobivis™ and Aflivu, Apotex's aflibercept biosimilar. Together, these medicines reflect our growing presence in ocular care and reinforce our ongoing contribution to a strong and reliable healthcare system for patients nationwide." Healthcare professionals should consult the complete Product Monograph for detailed information on dosing, administration, warnings, precautions, and adverse reactions. About Apotex Apotex is a Canadian‑based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people around the world, with a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, we are the largest Canadian‑based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more at . [1] Product Monograph SOURCE Apotex Inc. 21% more press release views with Request a Demo

Drug Approval

16 Apr 2026

·www.biospace.com

Harrow Announces the Issuance of J-Code for IOPIDINE® 1%

Reimbursement for Office-Based Utilization to Begin in July 2026 NASHVILLE, Tenn., April 16, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that IOPIDINE ® 1% (apraclonidine hydrochloride ophthalmic solution) has been assigned a permanent J-Code (J2374) by the Centers for Medicare & Medicaid Services (CMS). Effective July 1, 2026, IOPIDINE 1% will be reimbursed when administered in the in-office setting. J-Codes are CMS billing designations that allow physicians to be reimbursed directly for drugs administered in their offices. The assignment of a permanent J-Code removes a longstanding practical barrier to routine use of IOPIDINE 1% for office-based procedures, making it administratively and economically feasible for physicians to incorporate IOPIDINE 1% into standard glaucoma and ophthalmic laser procedure workflows. Addressing a Well-Defined Clinical Need IOPIDINE 1% is the only FDA-approved product indicated to prevent intraocular pressure (IOP) spikes following ophthalmic procedures, including in-office laser procedures such as Yttrium Aluminum Garnet (YAG), Nd capsulotomy, selective laser trabeculoplasty (SLT), argon laser trabeculoplasty (ALT), laser peripheral iridotomy (LPI), and others. With its established efficacy and safety profile, IOPIDINE 1% is positioned to be the front-line standard of care—administered at the time of the procedure – to help mitigate risk before IOP elevations occur. IOP spikes — sudden, acute elevations in pressure inside the eye — are a recognized complication of these procedures. In patients who experience significant spikes, symptoms can include sudden eye pain, blurred vision, nausea, and, in vulnerable patients, optic nerve damage. Prophylactic use of IOPIDINE 1% has been shown to reduce severe IOP spikes from approximately 23% in untreated patients to approximately 2% — a roughly 91% relative risk reduction. i Dr. Ben Gaddie, OD, added, “Optometrists are the front-line physicians diagnosing and managing glaucoma in the United States, and increasingly, performing laser procedures such as YAGs, SLTs, and LPIs. I am thrilled to now have reimbursed access to an on-label therapy to best ensure my patients are protected from intraocular pressure spikes. I truly appreciate Harrow’s commitment to helping my patients gain affordable access to sight-preserving products like Iopidine 1%.” “This is ultimately about removing friction—for physicians and for patients,” said Dr. Jason Bacharach, MD. “As a glaucoma specialist, having a reimbursed, in-office option means I can treat patients in real time as I am counseling my patients about the worrisome potential effects of not controlling their eye pressure. For many patients, especially those patients new to navigating their glaucoma diagnosis, that first experience sets the tone. Making therapy accessible at that moment can have a meaningful impact on adherence, outcomes, and peace of mind.” With the J-Code now issued and effective as of July 1, 2026, Harrow believes physicians will have both the clinical and economic rationale to make prophylactic IOP management a consistent part of their procedural care. A Growing Market with Room for Adoption Aside from the greater than 4 million ii American glaucoma patients who are regularly seen in clinics, in-office laser procedures represent a large and expanding segment of ophthalmic care. More than 1.5 million iii ophthalmic laser procedures are performed annually in the United States, a figure that continues to grow as the population ages and earlier intervention becomes standard practice. The J-Code designation establishes the reimbursement infrastructure to support broader and more consistent utilization of IOPIDINE 1% over time. Preventing IOP spikes also has the potential to reduce overall healthcare costs by minimizing the need for additional follow-up visits, urgent interventions, and the risk of complications that may require more complex procedures. "Every decision we make around the time of a procedure matters,” said Dr. Kyle Linsey, DO, Cataract and Refractive Surgeon. “When I can administer a proven pressure-lowering therapy immediately following a procedure—especially for high-risk patients—it’s a game-changer for my practice protocols. It gives both the physician and the patient confidence that we’re starting from a position of control, not uncertainty. It’s a must-have for high-risk patients after a laser procedure." “We are excited to deliver this wonderful news on IOPIDINE 1%, the first of the three Specialty products I highlighted earlier this year in my Letter to Stockholders,” said Mark L. Baum, Chief Executive Officer of Harrow. “This permanent J-Code represents an opportunity to ensure more patients in need have access to a medicine that can protect and preserve their vision. IOPIDINE 1% has a long-established and highly differentiated clinical profile, and now, with assured reimbursement from use in the physician’s office, the elimination of longstanding reimbursement friction is expected to drive broader, more consistent adoption—and is a particularly natural complement to IHEEZO ® for so many office-based procedures requiring an anesthetic.” About IOPIDINE ® 1% (apraclonidine hydrochloride ophthalmic solution) as base Indications and Usage IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy. Important Safety information CONTRAINDICATIONS IOPIDINE 1% Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine WARNINGS AND PRECAUTIONS Since IOPIDINE 1% Ophthalmic Solution is a potent depressor of IOP, patients who develop exaggerated reductions in IOP should be closely monitored. Although the acute administration of two drops of IOPIDINE 1% Ophthalmic Solution has minimal effect on heart rate or blood pressure in clinical studies evaluating patients undergoing anterior segment laser surgery, the preclinical pharmacologic pro this drug suggests that caution should be observed in treating patients with severe cardiovascular disease including hypertension. IOPIDINE 1% Ophthalmic Solution should also be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, chronic renal failure, Raynaud’s disease or thromboangiitis obliterans. The possibility of a vasovagal attack occurring during laser surgery should be considered and caution used in patients with history of such episodes. Topical ocular administration of two drops of 0.5%, 1%, and 1.5% IOPIDINE Ophthalmic Solution to New Zealand Albino rabbits three times daily for one month resulted in sporadic and transient instances of minimal corneal cloudiness in the 1.5% group only. No histopathological changes were noted in those eyes. No adverse ocular effects were observed in cynomolgus monkeys treated with two drops of 1.5% IOPIDINE Ophthalmic Solution applied three times daily for three months. No corneal changes were observed in 320 humans given at least one dose of IOPIDINE 1% Ophthalmic Solution. ADVERSE REACTIONS The following adverse events, occurring in less than 2% of patients, were reported in association with the use of IOPIDINE 1% Ophthalmic Solution in laser surgery: ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis. DOSAGE AND ADMINISTRATION Instill one drop of IOPIDINE ® 1% in the operative eye one hour before anterior segment laser surgery. Instill a second drop immediately after the procedure. Use a new single-use container for each drop and discard after use. About IHEEZO (chloroprocaine HCl ophthalmic gel) 3% Indications and Usage IHEEZO ® (chloroprocaine HCl ophthalmic gel) 3% is indicated for ocular surface anesthesia. Important Safety information IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation. IHEEZO should not be injected or intraocularly administered. Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip to any surface as this may contaminate the gel. IHEEZO is indicated for administration under the direct supervision of a healthcare provider. IHEEZO is not intended for patient self-administration. The most common adverse reactions in studies following IHEEZO administration (incidence greater than or equal to 5%) were mydriasis, conjunctival hyperemia, and eye irritation. 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 retina diseases. 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 Iopidine ® (apraclonidine HCl ophthalmic solution) 0.5% and 1% Prescribing Information. Harrow, Inc ii Ehrlich et al. JAMA Ophthalmol 2024 iii CMS Part B laser procedure estimates

100 Deals associated with Chloroprocaine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00732	Chloroprocaine Hydrochloride	N01BA04	DB01161

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Eye Diseases	Canada	Apotex, Inc.	14 May 2026
Anesthesia	United States	Fresenius Kabi USA LLC	11 Mar 1955
Neurolytic Block	United States	Fresenius Kabi USA LLC	11 Mar 1955
Tissue infiltration	United States	Fresenius Kabi USA LLC	11 Mar 1955

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cataract	Phase 3	Italy	Sintetica SA	09 Sep 2020
Cataract	Phase 3	Slovakia	Sintetica SA	09 Sep 2020
Cataract	Phase 3	Spain	Sintetica SA	09 Sep 2020
Analgesia	Phase 3	Belgium	Sintetica SA	01 Oct 2016
Flatfoot	Phase 2	Italy	Sintetica SA	14 Feb 2019
Flatfoot	Phase 2	Spain	Sintetica SA	14 Feb 2019
Hernia, Inguinal	Phase 2	Italy	Sintetica SA	14 Feb 2019
Hernia, Inguinal	Phase 2	Spain	Sintetica SA	14 Feb 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05926258 (CTgov)	Phase 3	Anesthesia	74	Chloroprocaine 3% eye gel (Chloroprocaine 3% Gel)	tnebskfbjh = fninpcivea nqlzbctflx (wehytxmzos, kqxgmbfqke - gswozjdiiy) View more	-	09 Mar 2026
				Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops (Oxybuprocaine 0,4% Solution)	tnebskfbjh = gdgjqvqqab nqlzbctflx (wehytxmzos, hixjpquhle - xcyudrtaiv) View more
NCT03324984 (CTgov)	Phase 2	Anesthesia	110	1% chloroprocaine (1% Chloroprocaine (PF))	rvxiynamie(ddgeqvjifp) = hoiyzlezdo ghfrxapnki (rzpirzrsbm, 8.6) View more	-	28 Feb 2025
				bupivacaine (0.75% Bupivacaine)	rvxiynamie(ddgeqvjifp) = plueyfujsa ghfrxapnki (rzpirzrsbm, 10.3) View more
NCT03324984 (Pubmed \| Reg Anesth Pain Med)	Phase 2	Rectal Diseases	110	1% Chloroprocaine Hydrochloride	yvplxgyoeh(oqqhrjxdem) = zqxwwcymzq twhzbhumsw (vynobiaotf, 6.6)	Positive	31 Dec 2024
				0.75% Bupivacaine	yvplxgyoeh(oqqhrjxdem) = thhhzsmkvh twhzbhumsw (vynobiaotf, 9.4)
NCT03760718 (CLOR-PRO, CTgov)	Early Phase 1	-	15	Preservative free 1% Chloroprocaine (Preservative Free Chloroprocaine Group 1)	ahffpdacvd(ifpufglzfq) = fzdqvxjjss lygzsfqlcy (fpquwwecmi, rbsmebmaap - gdwpzhpczj) View more	-	19 Sep 2024
				Chloroprocaine (Preservative Free Chloroprocaine Group 2)	ahffpdacvd(ifpufglzfq) = kffkfzxlzd lygzsfqlcy (fpquwwecmi, zuoiuptmnr - uoohilsklp) View more
NCT04685538 (Pubmed \| J Ocul Pharmacol Ther) Manual	Phase 3	Cataract	338	Chloroprocaine 3% gel	oxhewfwjox(krfpjwawir) = immdewnpsj ztjvokbidp (zortxxowxq ) View more	Positive	01 Mar 2024
				Tetracaine 0.5% eye drops	oxhewfwjox(krfpjwawir) = akeojznsut ztjvokbidp (zortxxowxq ) View more
NCT02919072 (CTgov)	Phase 3	Pain \| Analgesia	16	Chloroprocaine (Chloroprocaine)	ulpwvrayjk(vlymphbtha) = fdgghmpgmy ndeokzlfcv (vipsvbskho, 5.8) View more	-	21 Nov 2023
				Ropivacaine (Ropivacaine)	ulpwvrayjk(vlymphbtha) = ozvidylxio ndeokzlfcv (vipsvbskho, 4) View more
NCT04369950 (Pubmed \| Anesth Analg)	Not Applicable	Pain, Postoperative	40	2% lidocaine with 1:200,000 epinephrine and sodium bicarbonate	eevhizufpv(ffmtuvshbk) = ooxefvrnlk jgvkwmbiqj (ygofanqjfu, 6.3 - 22.5)	-	01 Jan 2023
NCT04685538 (CTgov)	Phase 3	Cataract	338	Chloroprocaine 3% (Chloroprocaine 3%)	mbzqdaqcax = szidimfaja ujhwggaoqa (gtlvduisvp, evyveveexv - jbfunivuxu) View more	-	27 Oct 2022
				Tetracaine 0.5% (Tetracaine 0.5%)	mbzqdaqcax = lmpgmuilzv ujhwggaoqa (gtlvduisvp, ocsogqogky - sehotnwtrk) View more
NCT03760718 (Pubmed \| Anesth Analg)	Early Phase 1	-	-	1% Chloroprocaine solution	nkmuuzsyfm(wccbbavkhu) = mguhntrbze gpienicstb (lsamlxfhmm )	Positive	01 Oct 2022
				2% Chloroprocaine solution	nkmuuzsyfm(wccbbavkhu) = yagfhyeziu gpienicstb (lsamlxfhmm )
NCT01719237 (CTgov)	Phase 4	Pain	60	Ropivacaine+Cholroprocaine (Ropivacaine and Cholroprocaine Mixture)	nvjwhpxivv(nybbusrswx) = ahrzlnggsz fpfqacsszn (fcpjgxnabk, pvqumqlmoc - zyychnahxe) View more	-	14 Sep 2022
				Ropivacaine (Ropivacaine Only)	nvjwhpxivv(nybbusrswx) = knzfnpidyl fpfqacsszn (fcpjgxnabk, slkxhoiyac - gsgysvpjrs) View more

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