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Phase 3 trial shows vernal keratoconjunctivitis drug improved signs, symptoms in children
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EVRY, France — Novagali Pharma announced positive results from a pivotal phase 3 clinical trial of Vekacia in children suffering from vernal keratoconjunctivitis. The drug improved both signs and symptoms of the disease and was well-tolerated by patients, according to a press release from the company.
Vekacia is a cationic emulsion of cyclosporine A. The study evaluated the efficacy of two doses of the drug — 0.05% and 0.1% — administered four times daily vs. vehicle over 4 weeks. Secondary objectives included subjective and objective ocular tolerance as well as long-term safety after 4 months of use.
The trial enrolled 118 children who averaged 8.8 years of age from May 2006 to October 2006. All children had active bilateral vernal keratoconjunctivitis.
Investigators found both drug concentrations produced a better overall improvement in subjective symptoms compared with patients who received vehicle. Both concentrations also significantly improved objective signs, including conjunctival erythema or hyperemia, conjunctival chemosis and discharge, papillae, limbal infiltrates and corneal epithelial disease.
Superficial keratitis also was significantly improved with treatment with Vekacia 0.05% vs. vehicle. And patients in both treatment arms showed negligible systemic exposure to cyclosporine, the release said.