A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis
Phase of Trial: Phase III
Latest Information Update: 14 Nov 2019
Price : $35 *
At a glance
- Drugs Ciclosporin (Primary)
- Indications Allergic conjunctivitis
- Focus Registrational; Therapeutic Use
- Sponsors Santen S.A.S.
- 10 Jul 2018 According to a Santen Pharmaceutical media release, based on the data from this study, the European Commission has granted marketing approval for DE-076C (Verkazia, eye drop emulsion containing 0.1% (1mg/ml) ciclosporin) for the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
- 04 Oct 2017 Status changed from active, no longer recruiting to completed.
- 24 Jul 2017 According to a European Medicines Agency media release, based on the data from this study, the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Verkazia (ciclosporin) in the European Union (EU) for the treatment of severe vernal keratoconjunctivitis (VKC).