Harrow Re-Launches VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1% for Vernal Keratoconjunctivitis, Addressing Significant Unmet Need in Pediatric Eyecare
- VERKAZIA is now supported by a comprehensive commercial strategy focused on physician education, patient access, and affordability initiatives to ensure dependable supply and remove access barriers
- VERKAZIA is indicated for the treatment of all forms of vernal keratoconjunctivitis (VKC), a serious allergic eye disease that primarily affects children and may lead to sight-threatening conditions if left untreated or undertreated
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VERKAZIA is a calcineurin inhibitor immunomodulator that targets the underlying inflammatory mechanisms of VKC and may reduce the need for steroid rescue, all of which are associated with risks such as glaucoma or cataract formation
NASHVILLE, Tenn., June 10, 2026 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the re-launch of VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1%, a prescription therapy indicated for the treatment of vernal keratoconjunctivitis (VKC), a serious allergic eye disease that primarily affects children.
“The re-launch of VERKAZIA underscores our commitment to advancing care in underserved ophthalmic conditions,” said Mark L. Baum, Chief Executive Officer of Harrow. “As outlined in our recent Letter to Stockholders, VERKAZIA is the second of three priority products within our portfolio that we are actively executing against. VKC is a clinically significant, yet highly underdiagnosed disease, affecting a vulnerable patient population, where the central challenge has not been clinical efficacy, but consistent access to therapy. Our focus with this re-launch is straightforward: ensure dependable supply, remove access barriers, and enable physicians and patients to reliably obtain this important, evidence-based, and, most importantly, steroid-sparing treatment, for long-term disease management.”
“Vernal keratoconjunctivitis is more than a seasonal allergy—it is a chronic inflammatory disease that can meaningfully disrupt a child’s daily life and long-term ocular health,” said Dr. Angela Zhu, M.D., Pediatric Ophthalmologist at Bascom Palmer Eye Institute. “Targeted therapies like VERKAZIA that address the underlying immune response are essential to improving both symptom control and disease trajectory.”
“There remains a substantial need for effective, long-term VKC treatment options, particularly those that reduce steroid exposure,” said Dr. Elsa Sheerer, OD., Pediatric Optometrist at NYC Health + Hospitals. “The availability of a targeted cyclosporine formulation is an important advancement for clinicians managing this complex disease.”
VKC is a chronic, potentially sight-threatening condition perpetuated by significant ocular inflammation, often resulting in severe itching, pain, photophobia, and, in some cases, corneal damage. The disease typically begins in early childhood and may persist for years—often through adolescence—with seasonal exacerbations and, in some cases, continuation into adulthood. VKC has been shown to significantly impact quality of life, affecting school performance, outdoor activity, sleep, and social development—often disproportionately to clinical severity. Despite its meaningful clinical burden and impact on quality of life, treatment options for VKC—particularly in pediatric populations—have historically been limited.
Pediatric patients are typically initiated on antihistamines; however, approximately 61% of VKC patients are inadequately controlled on antihistamines alone.i When antihistamines fail to provide sufficient relief, clinicians have historically turned to corticosteroids—but chronic steroid use in children carries significant risks, including glaucoma and cataract formation. Prior to VERKAZIA, no FDA-approved steroid-sparing therapy existed for VKC, leaving a substantial gap in care for both mild and severe patients.
VERKAZIA is a topical calcineurin inhibitor immunomodulator that targets the underlying inflammatory mechanisms of VKC. Consensus guidelines increasingly support the early use of calcineurin inhibitors to control inflammation, reduce reliance on corticosteroids, and improve long-term outcomesii. Unlike chronic steroid use, VERKAZIA does not carry risks such as glaucoma or cataract formation, making it particularly important in pediatric populations.
In randomized, controlled clinical trials, VERKAZIA demonstrated statistically significant improvements in corneal damage (keratitis), meaningful reductions in hallmark symptoms such as itching, photophobia, and tearing, and decreased need for corticosteroid rescue therapy compared to control—supporting its role as a foundational, steroid-sparing therapy for long-term VKC management.iii
From a market perspective, VKC represents a durable and underdiagnosed segment within ophthalmology, with increasing clinical awareness and a growing emphasis on early, disease-modifying treatment. The condition’s chronicity, pediatric onset, and need for long-term management contribute to sustained demand for safe, well-tolerated therapies.
Harrow’s re-launch of VERKAZIA is supported by a comprehensive commercial strategy focused on physician education, patient access, and affordability initiatives, with the goal of improving diagnosis, treatment adoption, and continuity of care.
Clinicians seeking to prescribe VERKAZIA can contact 1-833-4HARROW (1-833-442-7769) or at this link. Additional product details can be found on the product website.
VERKAZIA®
(cyclosporine ophthalmic emulsion) 0.1%
Indications and Usage
Verkazia® (cyclosporine ophthalmic emulsion) 0.1% is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults.
Important Safety information
WARNINGS AND PRECAUTIONS
Potential for eye injury and contamination: To avoid the potential for eye injury and contamination, advise patient not to touch the vial tip to the eye or other surfaces.
ADVERSE REACTIONS
The most common adverse reactions reported in greater than 5% of patients were eye pain (12%) and eye pruritus (8%), which were usually transitory and occurred during instillation.
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 Ophthalmology, 2024 — Steroids Dominate Treatment of VKC
ii VKC Consensus Statement 2023
iii VERKAZIA Clinical Data
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