Vekacia impresses in Ph II/III VKC trial

French ophthalmic drugmaker Novagali Pharma says that its developmental product Vekacia, a cyclosporin-based agent, improved both signs and symptoms of vernal keratoconjunctivits in children suffering from the condition. The findings, which were announced at the 14th Afro-Asian Congress of Ophthalmology held in Morocco, are based on data from a Phase II/III clinical study of the drug, conducted at 21 sites in Europe.

The program, which was designed to examine Vekacia's efficacy and safety, was a randomized parallel group, dose-ranging assessment that was divided into two phases: a four-week vehicle-controlled treatment period; and a three-month double-blind section. In total, 118 children, 76.3% of whom were suffering from perennial VKD, were enrolled and were provided with one of two doses of the drug (0.05% or 0.1%) or a vehicle control, administered four times a day.

The results showed that treatment reduced both the subjective symptoms (burning/stinging, itching, pain, photophobia, etc) and the objective effects (conjunctival erythema/hyperhemia, papillae, limbal infiltrates and corneal epithelial degradation) of the disorder. Similarly, the 0.05% formulation brought about a statistically-significant improvement in superficial keratitis when compared with the control.