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Novagali Pharma Presents at AACO the Results of its Pivotal Phase,III Clinical Trial of Vekacia in Children Suffering From Vernal,Keratoconjunctivitis

at study entry with a mixed form of VKC (87 patients, 73.7%).

Vekacia(R) improved both signs and ocular symptoms of VKC in children who received treatment. The superiority of Vekacia(R) over its vehicle has been demonstrated by the statistically significant improvement of both objective signs of VKC and keratitis in treated patients. Both doses were safe and well tolerated. Local tolerance at instillation was satisfactory and therefore compliance to the recommended dose regimen of four instillations per day was good. Systemic exposure to CsA was negligible in the treated patients. Compliance to the study regimen of four daily instillations of the drug was excellent.

Overall improvement of subjective symptoms (burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge and photophobia) was superior to the vehicle for both concentrations of Vekacia(R). For objective signs (conjunctival erythema/hyperhemia, conjunctival chemosis and discharge, papillae, limbal infiltrates and corneal epithelial disease), there was a statistically significant difference between both concentrations of Vekacia(R) and the vehicle treatment (p=0.0386 and 0.0208 for the Vekacia(R) 0.05% and Vekacia(R) 0.1% treatment arms, respectively). Similarly, improvement in superficial keratitis was statistically significant with Vekacia(R) 0.05% versus vehicle (p=0.0176).

At one month of study, only seven patients had withdrawn from the study, which comprised four patients using the vehicle and three patients using Vekacia(R), including one case of ocular intolerance following study drug instillation. Few treatment-emergent adverse effects (TEAEs) were reported, the most frequent being eye disorders of mild intensity. The tested formulations were rated as comfortable by 94.4% (vehicle), 79.5% (Vekacia(R) 0.05%) and 80.6% (Vekacia(R) 0.1%). Blood levels of CsA were assayed after one month of treatment in 16 patients treated with Vekacia(R) and
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