Verkazia
Authorised
This medicine is authorised for use in the European Union
ciclosporin
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Verkazia. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
It is not intended to provide practical advice on how to use Verkazia.
For practical information about using Verkazia, patients should read the package leaflet or contact their doctor or pharmacist.
Verkazia is a medicine used to treat severe vernal keratoconjunctivitis (VKC), an allergic condition that affects the eye and mostly occurs seasonally, although in some patients symptoms can recur or persist all year round. It is used in children and adolescents from 4 to 18 years of age.
Because the number of patients with vernal keratoconjunctivitis is low, the disease is considered ‘rare’, and Verkazia was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 6 April 2006.
Verkazia contains the active substance ciclosporin.
Verkazia can only be obtained with a prescription and treatment must be started by a healthcare professional qualified in ophthalmology (eye medicine).
Verkazia is available as eye drops. The recommended dose is 1 drop 4 times a day in each affected eye, during VKC season. If symptoms persist after the end of the season, Verkazia can continue to be used at the recommended dose until symptoms are under control and at a reduced dose (1 drop twice a day) thereafter.
For further information, see the package leaflet.
The active substance in Verkazia, ciclosporin, blocks cells of the immune system (the body’s natural defences) that are involved in the processes that cause the allergic reaction and inflammation in patients with VKC. Applying it directly to the eye reduces eye inflammation but limits its effects elsewhere in the body.
Verkazia reduces damage to the cornea (layer in the front of the eye) in most patients with VKC as shown by improvements in ‘corneal fluorescence staining’ (CFS) scores (a standard measure of corneal health).
In a main study involving 169 children and adolescents with severe VKC, 55% of patients treated with Verkazia achieved CFS improvements of 50% or more, without the need of other medications, after 4 months, compared with around 28% of patients receiving a dummy treatment. Symptoms such as itching, fluid or mucous discharge and light sensitivity also improved in patients treated with Verkazia to a greater extent than with the dummy treatment. Some of the patients were treated for an additional 8 months; this extension study showed that the benefits of Verkazia were maintained with continued use for up to 12 months.
The most common side effects with Verkazia are eye pain and itching, which may affect around 1 in 10 people. These symptoms usually occur when the drops are being put in the eyes and go away shortly after.
Verkazia must not be used in patients with active or suspected infections in or around the eye.
For the full list of all side effects and restrictions with Verkazia, see the package leaflet.
Verkazia has been shown to be effective at improving the condition of the cornea and reducing the symptoms of the disease. Side effects are mostly mild and disappear shortly after application of the medicine. The European Medicines Agency therefore decided that Verkazia’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verkazia have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Verkazia on 6 July 2018.
For more information about treatment with Verkazia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: R/0021
31/03/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Verkazia
- Active substance
- ciclosporin
- International non-proprietary name (INN) or common name
- ciclosporin
- Therapeutic area (MeSH)
- Conjunctivitis
- Keratitis
- Anatomical therapeutic chemical (ATC) code
- S01XA18
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
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