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DailyMed – VERKAZIA- cyclosporine emulsion


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).

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)

[1] 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)

Table 3

[1] 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.



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