Press Releases August 20, 2026 07:00 AM

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

Harrow Reports Positive Study Results for IHEEZO® Ophthalmic Gel Reducing Discomfort Following Intravitreal Injections

By Hana Yamamoto
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Harrow announced positive results from a prospective, randomized study demonstrating that their ophthalmic gel, IHEEZO® (chloroprocaine hydrochloride 3%), significantly reduces patient-reported discomfort following intravitreal injections compared to proparacaine 0.5%. The study, involving 50 patients undergoing bilateral same-day injections, showed approximately 58% less discomfort with IHEEZO, especially immediately after injections, which could improve patient experience in retina care practices.

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

  • IHEEZO® ophthalmic gel significantly reduces patient discomfort during and after intravitreal injections compared to conventional proparacaine solution.
  • The study was conducted as a contralateral-eye trial in 50 patients to control variability and showed consistent benefit across 24 hours post-injection.
  • Intravitreal injections are among the most commonly performed ophthalmic procedures in the U.S., making improved anesthetic options valuable for patient compliance and practice efficiency.

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.

Millionsi 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 profile versus 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 profile and 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
[email protected]
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 https://www.globenewswire.com/NewsRoom/AttachmentNg/0eb365b1-2cee-40b7-880d-fba9189e1d92


Risks

  • Potential adverse reactions including mydriasis, occurring in approximately 25% of patients, may limit adoption.
  • Regulatory risks including ongoing FDA communications about Harrow's facilities and product compliance could impact commercialization.
  • Market competition from existing anesthetic solutions and challenges in scaling adoption among retina specialists pose commercial risks.

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