お知らせ • Jun 10
Harrow Re-Launches Verkazia Cyclosporine Ophthalmic Emulsion 0.1% for Treatment of Vernal Keratoconjunctivitis
Harrow 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. 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. 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. 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. 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 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. 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. VERKAZIA® (cyclosporine ophthalmic emulsion) 0.1% is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults. 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.