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

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 millionⁱⁱ 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 millionⁱⁱⁱ 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 profile of 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

[email protected]

617-913-8890

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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