Harrow Re-Launches VERKAZIA, First FDA-Approved Steroid-Sparing Therapy for Vernal Keratoconjunctivitis
核心洞察
Harrow has reintroduced VERKAZIA (cyclosporine ophthalmic emulsion) 0.1% to the U.S. market, the first and only FDA-approved topical immunomodulator for pediatric VKC.
VKC is a chronic, potentially sight-threatening allergic eye disease primarily affecting children, with approximately 61% of patients inadequately controlled on antihistamines alone.
VERKAZIA targets underlying inflammatory mechanisms without the risks of glaucoma or cataract formation associated with chronic corticosteroid use.
Harrow (Nasdaq: HROW) announced on June 10, 2026 the re-launch of VERKAZIA (cyclosporine ophthalmic emulsion) 0.1% to the U.S. commercial market, restoring access to the first and only FDA-approved topical immunomodulator indicated for vernal keratoconjunctivitis (搜索) (VKC) in both children and adults. The reintroduction addresses what the company describes as a substantial gap in care for a disease that has historically lacked steroid-sparing treatment options.
"Prior to VERKAZIA, no FDA-approved steroid-sparing therapy existed for VKC, leaving a substantial gap in care for both mild and severe patients," Harrow noted in its announcement.
A Challenging Path Back to Market
VERKAZIA was originally developed by Santen Inc., the U.S. subsidiary of Santen Pharmaceuticals Co. Ltd., and received FDA approval in June 2021. The therapy first launched in the U.S. market in May 2022 under the Santen name. In July 2023, Harrow announced its acquisition of North American commercial rights for VERKAZIA alongside several other ophthalmic products in the Santen portfolio, completing the transfer of new drug applications (NDAs) by October 2023. In February 2024, Harrow out-licensed Canadian rights for VERKAZIA and four other ophthalmic products to Apotex (搜索) Inc.
The company reported inventory shortages in late 2025 that extended into early 2026, with Q1 2026 financial results described by Harrow as not reflecting "the true state of our business." Despite these challenges, CEO Mark L. Baum expressed optimism in communications to shareholders: "We are entering a period of accelerating commercial execution." VERKAZIA is one of three "priority" products being positioned with "the potential to unlock new on-label markets" and "contribute meaningful incremental revenue."
Clinical Need in Pediatric Eyecare
VKC is a chronic, potentially sight-threatening condition driven by significant ocular inflammation, manifesting as severe itching, pain, photophobia, and in some cases, corneal damage. The disease typically begins in early childhood and may persist through adolescence, with seasonal exacerbations and occasional 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.
Pediatric patients are typically initiated on antihistamines; however, approximately 61% of VKC patients are inadequately controlled on antihistamines alone. When antihistamines fail, clinicians have historically turned to corticosteroids—but chronic steroid use in children carries significant risks, including glaucoma and cataract formation.
"Vernal keratoconjunctivitis (搜索) 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."
Dr. Elsa Sheerer, OD., Pediatric Optometrist at NYC Health + Hospitals, added: "There remains a substantial need for effective, long-term VKC treatment options, particularly those that reduce steroid exposure. The availability of a targeted cyclosporine formulation is an important advancement for clinicians managing this complex disease."
Mechanism and Clinical Evidence
VERKAZIA is a topical calcineurin (搜索) 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 outcomes. 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.
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.
Commercial Strategy and Access
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.
"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," Baum stated.
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.
Clinicians seeking to prescribe VERKAZIA can contact 1-833-4HARROW (1-833-442-7769).