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

(Moderate)
(Very Positive)
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Harrow (Nasdaq: HROW) reported new data from a prospective, randomized, contralateral-eye study of IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% in 50 adults (100 eyes) receiving same-day bilateral intravitreal injections.

Each patient received IHEEZO in one eye and preservative-containing proparacaine 0.5% in the fellow eye, after 2% lidocaine-soaked pledgets in both eyes. According to Harrow, patients reported approximately 58% less overall discomfort in the IHEEZO-treated eye, with statistically significant differences at all four post-injection assessments (all p≤0.048) on a 0–10 numeric rating scale.

The largest absolute differences occurred when discomfort is typically highest, immediately after injection: scores of 1.44 vs 3.06 at two minutes and 1.26 vs 2.82 at one hour, favoring IHEEZO. Lower discomfort scores with IHEEZO persisted through the 24-hour assessment. IHEEZO is indicated for ocular surface anesthesia; the most common adverse reaction is mydriasis (approximately 25%), and it is contraindicated in patients with hypersensitivity to any component.

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Positive

  • ≈58% reduction in overall discomfort in IHEEZO-treated eyes versus proparacaine, all p≤0.048
  • Largest absolute pain score gaps shortly post-injection: 1.44 vs 3.06 at 2 minutes; 1.26 vs 2.82 at 1 hour
  • Consistent lower discomfort with IHEEZO at all four time points through 24 hours in 100-eye study
  • Randomized contralateral-eye design lets each of 50 patients serve as own control, reducing between-patient variability

Negative

  • Data from single-center study in a single private retina practice with 50 adult patients
  • Adverse reaction mydriasis reported in approximately 25% of IHEEZO-treated cases
  • Contraindicated in hypersensitivity to any component of IHEEZO, limiting use in those patients
  • Not for injection or intraocular use; must be administered only by a healthcare provider

Market Context

Recent insider data recorded 11,250 shares sold, adding a separate governance and liquidity consider...
Analysis

Recent insider data recorded 11,250 shares sold, adding a separate governance and liquidity consideration to the IHEEZO clinical evidence. The platform record supports monitoring whether improved comfort translates into broader physician adoption.

Key Figures

Overall discomfort reduction: approximately 58% Statistical significance: all p≤0.048 2-minute discomfort scores: 1.44 versus 3.06 +5 more
8 metrics
Overall discomfort reduction approximately 58% IHEEZO-treated eye versus fellow eye
Statistical significance all p≤0.048 four post-injection assessments
2-minute discomfort scores 1.44 versus 3.06 IHEEZO versus proparacaine
1-hour discomfort scores 1.26 versus 2.82 IHEEZO versus proparacaine
2-minute treatment difference 1.62 points numeric discomfort rating scale
1-hour treatment difference 1.56 points numeric discomfort rating scale
Study size 100 eyes from 50 adult patients prospective randomized contralateral-eye study
Most common adverse reaction approximately 25% mydriasis

Historical Context

5 past events · Latest: Aug 10 (Negative)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 10 2Q26 earnings report Negative -3.0% Revenue growth accompanied a quarterly net loss and reduced Adjusted EBITDA.
Aug 06 Acquisition agreement Positive +1.3% Global TYRVAYA rights acquired for cash and contingent milestone payments.
Jul 27 Earnings date notice Neutral -2.6% Scheduled second-quarter results release and conference call for August 10–11.
Jul 20 Phase 4 clinical data Positive -4.7% Interim BYOOVIZ surveillance results reported significant BCVA and CST changes.
Jul 20 IHEEZO clinical data Positive -4.7% ASRS presentations cited IHEEZO trends and ongoing QUELL enrollment.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive clinical-news events diverged from the stock response, each followed by a recorded 24-hour decline of 4.72%.

Key Terms

contralateral-eye study, intravitreal injections, numeric rating scale, ocular surface anesthesia, +1 more
5 terms
contralateral-eye study medical
"prospective, randomized, contralateral-eye study evaluating IHEEZO"
A contralateral-eye study is a clinical trial design in which one eye of each participant receives the experimental treatment while the other eye serves as an internal control. Like testing a lotion on one hand and leaving the other untreated, this approach reduces variability between subjects and can make it easier to spot differences in effect; its use influences how results, safety signals, trial size, regulatory assessment, and development timelines are interpreted by investors.
intravitreal injections medical
"patients undergoing same-day bilateral intravitreal injections"
An intravitreal injection is a medical procedure that delivers medication directly into the eye’s vitreous, the clear gel at the back of the eyeball, to treat retinal and other internal eye conditions. For investors it matters because these injections create recurring demand for specialty drugs, delivery tools and clinic services; treatment frequency, safety and reimbursement determine revenue size and predictability, similar to a subscription product for vision care.
numeric rating scale medical
"measured using a standard 0-to-10 numeric rating scale"
A numeric rating scale is a simple system that converts opinions or measurements into numbers so different items can be compared and tracked over time. For investors, it turns qualitative judgments—like analyst recommendations, credit risk, or clinical outcomes—into a clear score you can sort, average, or watch for changes, much like using a thermometer or star rating to quickly judge and compare options when making decisions.
ocular surface anesthesia medical
"an ophthalmic gel indicated for ocular surface anesthesia"
Topical medication applied to the eye surface to temporarily numb the cornea and conjunctiva, blocking pain and reflex blinking so exams, minor procedures, or device insertions can be performed comfortably. Like a numbing cream for the skin, it matters to investors because its safety, effectiveness, regulatory status, and ease of use can influence the adoption of ophthalmic drugs, surgical tools, and diagnostic devices, and thus affect market demand and clinical trial outcomes.
mydriasis medical
"Most common adverse reaction is mydriasis"
Mydriasis is the widening or dilation of the pupil, the dark center of the eye, that lets in more light—similar to a camera aperture opening wider. It can occur naturally in low light, because of certain medications, or as a side effect of treatments and is important to investors because it is a measurable clinical sign used in drug trials, ophthalmic product evaluations, and safety assessments that can affect regulatory reviews and market potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

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:

Patient-Reported Ocular Discomfort Following Intravitreal Injection

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
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 https://www.globenewswire.com/NewsRoom/AttachmentNg/0eb365b1-2cee-40b7-880d-fba9189e1d92


FAQ

What did Harrow (HROW) report about IHEEZO and intravitreal injection discomfort on August 20, 2026?

Harrow reported that IHEEZO-treated eyes had about 58% less overall discomfort versus proparacaine after intravitreal injections. According to Harrow, statistically significant reductions in patient-reported discomfort occurred at all four post-injection time points over 24 hours in a 50-patient, 100-eye randomized study.

How much did IHEEZO reduce pain scores compared with proparacaine in the Harrow (HROW) intravitreal injection study?

Patients reported meaningfully lower numeric rating scale scores in IHEEZO-treated eyes compared with proparacaine. According to Harrow, scores were 1.44 vs 3.06 at two minutes and 1.26 vs 2.82 at one hour post-injection, with lower discomfort persisting through 24 hours.

What was the design and size of the IHEEZO intravitreal injection study reported by Harrow (HROW)?

The study was a prospective, randomized, contralateral-eye comparison in a private retina practice. According to Harrow, it evaluated 100 eyes from 50 adult patients receiving same-day bilateral intravitreal injections, with each patient serving as their own control.

What is IHEEZO and what is it indicated for according to Harrow (HROW)?

IHEEZO is a 3% chloroprocaine hydrochloride ophthalmic gel used for topical ocular surface anesthesia. According to Harrow, it is an ester anesthetic indicated for ocular surface anesthesia and is administered by a healthcare provider, not intended for patient self-administration or intraocular injection.

What safety information and adverse reactions did Harrow (HROW) highlight for IHEEZO?

IHEEZO is contraindicated in patients with hypersensitivity to any component and is not for injection or intraocular use. According to Harrow, the most common adverse reaction is mydriasis, occurring in approximately 25% of treated cases, and corneal injury precautions are noted.

How might the new IHEEZO data affect retina specialists using Harrow (HROW) products?

The data suggest IHEEZO was associated with consistently lower discomfort after intravitreal injections versus proparacaine. According to Harrow, these real-world findings may support physician confidence in IHEEZO’s clinical profile when managing high-volume patients requiring repeated retinal injections.