The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for Verkazia (ciclosporin), intended for the treatment of severe vernal keratoconjunctivitis (VKC).
Verkazia , which was designated as an orphan medicinal product on 6 April 2006, was reviewed under the EMA’s accelerated assessment programme. The full indication is: “treatment of severe vernal keratoconjunctivitis in children from four years of age and adolescents”. Treatment with Verkazia must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology.
The EMA’s recommendation is mainly based on data from one phase III clinical trial involving 169 patients with severe VKC. The study showed that, after four months, more patients treated with Verkazia than with placebo had an improvement in corneal health while requiring no additional corticosteroid medication. After four months of treatment, all main VKC symptoms studied (light sensitivity, itching, tearing and mucous discharge) improved.
The orphan designation afforded to Verkazia will now be reviewed to determine whether the information available to date supports maintaining the orphan status and granting this medicine 10 years of market exclusivity.
The EMA opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.