Verkazia

Verkazia is an FDA-registered drug product whose active ingredient is CYCLOSPORINE. It is labelled by Harrow Eye, LLC taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 82667-014, application NDA214965, label effective 20260603. It is one of 9 FDA drug label records sharing the active ingredient CYCLOSPORINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CYCLOSPORINE are most often described in connection with: verkazia ophthalmic, treatment vernal, emulsion indicated, keratoconjunctivitis vkc, calcineurin inhibitor. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Verkazia ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults ( 1 )

2 DOSAGE AND ADMINISTRATION Instill one drop of Verkazia, 4 times daily (morning, noon, afternoon, and evening) in each affected eye ( 2 ) 2.1 General Dosing Information Gently shake the single-dose vial several times to obtain a uniform, white, opaque emulsion before use. Contact lenses should be removed before applying Verkazia and may be reinserted 15 minutes after administration. If a dose is missed, treatment should be continued as normal, at the next scheduled administration. If more than one topical ophthalmic product is being used, administer the eye drops at least 10 minutes apart to avoid diluting products. Administer Verkazia 10 minutes prior to using any eye ointment, gel or other viscous eye drops. Discard the vial immediately after use. 2.2 Recommended Dosage and Dose Administration Instill one drop of Verkazia, 4 times daily (morning, noon, afternoon, and evening) into each affected eye. Treatment can be discontinued after signs and symptoms are resolved and can be reinitiated if there is a recurrence.

4 CONTRAINDICATIONS None None ( 4 )

6 ADVERSE REACTIONS The most common adverse reactions following the use of Verkazia were eye pain (12%) and eye pruritus (8%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA‑approved patient labeling. 6.1 Clinical Trials Experience Since clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the VEKTIS study, a multicenter, randomized, double-masked, placebo‑controlled trial, a total of 57 patients received Verkazia dosed four times a day (QID) for 4 months. Forty-two (42) patients received Verkazia in an 8 month extension, safety follow-up of the VEKTIS study. In the NOVATIVE study, a multicenter, randomized, double-masked, placebo‑controlled trial, 39 patients received Verkazia 1 mg/mL dosed QID for one month. A total of 53 patients received Verkazia 1 mg/mL QID during a 3-month safety follow‑up. The majority of the treated patients were male (79%). 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 (Table 1). Table 1: Adverse Reactions Reported in ≥ 1% of Patients Receiving Verkazia (N=135) Eye Disorders Eye pain a 12% Eye pruritus b 8% Ocular discomfort c 6% Visual acuity reduced 5% Ocular hyperemia 4% Systemic Cough 5% Headache 4% Upper respiratory tract infection 2% a Including eye pain and instillation site pain b Including eye pruritus and instillation site pruritus c Including foreign body sensation and ocular discomfort

FDA lists 9 drug label records with CYCLOSPORINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Verkazia used for?
1 INDICATIONS AND USAGE Verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Verkazia ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults ( 1 )

Who makes Verkazia?
Harrow Eye, LLC is the labeler of record for Verkazia. 9 FDA label records share the active ingredient CYCLOSPORINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Verkazia come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Verkazia prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CYCLOSPORINE?
Yes. 9 FDA drug label records list CYCLOSPORINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Verkazia been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.