Verkazia Drug Information
Generic name: CYCLOSPORINE
Calcineurin Inhibitor Immunosuppressant [EPC]
Uses of Verkazia
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
Dosage & Administration of Verkazia
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.
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.
Side Effects of Verkazia
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 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
Warnings & Cautions for Verkazia
Potential for Eye Injury and Contamination To avoid the potential for eye
injury or contamination, advise patients not to touch the vial tip to the eye or other surfaces.
Clinical Studies of Verkazia
The safety and efficacy of Verkazia for the treatment of VKC was evaluated in two randomized, multi-center, double-masked, vehicle-controlled, clinical trials (VEKTIS Study NCT01751126 and NOVATIVE Study NCT00328653 ). and NOVATIVE Study NCT00328653). In the VEKTIS study, patients with severe VKC were randomized to four times daily of Verkazia 1 mg/mL or two times daily (BID) of Verkazia 1 mg/mL and vehicle group for the first 4 months (Period 1). Similarly, in the NOVATIVE study, patients with moderate to severe VKC were randomized to QID of Verkazia 1 mg/mL or QID of cyclosporine ophthalmic emulsion 0.5 mg/mL and vehicle group for the first 1 month (Period 1). In both studies, patients randomized to the vehicle group were switched to Verkazia (QID or BID) from Month 4 to Month 12 in VEKTIS Study and to cyclosporine ophthalmic emulsion 0.5 mg/mL QID or 1 mg/mL from Month 1 to Month 4 in NOVATIVE Study (Period 2). A total of 168 and 118 patients were enrolled in the VEKTIS and NOVATIVE studies for the efficacy analyses, respectively. Patients’ age ranged from 4 through 17 years (mean age 9 years) in VEKTIS and 4 through 21 years (mean age 9 years) in NOVATIVE, with most patients being between 4 and 11 years of age (76% in VEKTIS and 80% in NOVATIVE) and male (79% in VEKTIS and 81% in NOVATIVE). Most of the patients had both limbal and tarsal forms of VKC (65% in VEKTIS and 74% in NOVATIVE). In both studies, patients had experienced VKC for a mean of 3 years prior to enrollment and all patients had a history of at least one recurrence of VKC in the year prior to study entry. In the VEKTIS study, key efficacy evaluation was based on the change in corneal fluorescein staining (CFS) score and in itching score over 4 months.
The results at each month are presented in Table 2 for the CFS score and in Table 3 for the Itching score. Table 2: Efficacy Results of the Mean Change in Keratitis Score from Baseline at Each Visit (Full Analysis Set) Treatment differences (numbers in the middle of the horizontal lines) and 95% confidence intervals (horizontal lines) are based on ANCOVA model including baseline CFS score and the proportion of time potentially spent in taking study medication during the VKC season as covariate. For subjects that received rescue therapy during the study, all post-rescue data were imputed by the last available data observed prior to rescue initiation.
Note 1: CFS score was measured at each month using a 5-point scale (0 = no stain, and 5 = more stain). Note 2: The Full Analysis Set included all randomized subjects that received at least one drop of study medication. Table 3: Efficacy Results of the Mean Change in Itching Score from Baseline at Each Visit (Full Analysis Set) Treatment differences (numbers in the middle of the horizontal lines) and 95% confidence intervals (horizontal lines) are based on ANCOVA model including baseline Itching score and the proportion of time potentially spent in taking study medication as covariate. For subjects that received rescue therapy during the study, all post-rescue data were imputed by the last available data observed prior to rescue initiation.
Note 1: Itching score at each visit was measured using a Visual Analogue Scale (0 = no itch to 100 = maximal itch). Analyses of the CFS score and Itching score at Month 1 of the efficacy evaluation period in the NOVATIVE Study also provided supporting evidence. Table 2 Table 3
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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