What is Ikervis - Ciclosporina used for and what is it used for?
Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent membrane that covers the front of the eye) in adult patients with dry eye syndrome. It is used when treatment with tear substitutes (artificial tears) is insufficient to improve the condition. Ikervis contains the active substance cyclosporine.
How is Ikervis - Cyclosporine used?
Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional experienced in ophthalmology (medicine that studies the eye). The medicine is available as single dose eye drops; the recommended dose is one drop to be applied to the affected eye or eyes before going to sleep. The doctor must reconfirm the need to continue the treatment at least every 6 months. If other eye drops are also used, they should be administered at least 15 minutes apart. Ikervis should be administered last. For more information, see the package leaflet.
How does Ikervis - Cyclosporine work?
In dry eye syndrome a quantity of tear fluid is produced which is insufficient to create the protective lubricating film that normally covers the ocular surface or there is too rapid evaporation of the aqueous component due to anomalies of lacrimal secretion. Without the adequate protection of the tear fluid, the cornea can be damaged and become inflamed (keratitis), resulting in the onset of ulcer, infection and reduced vision. The active ingredient of Ikervis, ciclosporin, acts on the cells of the immune system (the body's natural defenses) implicated in inflammatory processes. Applied directly to the eye, it reduces inflammation and lesion locally without its effects being distributed to other parts of the body.
What benefit has Ikervis - Cyclosporine shown during the studies?
The benefits of Ikervis have been demonstrated in a main study involving 246 patients suffering from severe dry eye syndrome, in which Ikervis was compared to the vehicle (the same formulation of eye drops but without the active ingredient). The main measure of effectiveness was the percentage of patients in whom the disease responded to treatment after six months; the response was measured in terms of corneal lesions and score of symptom assessment, including discomfort and pain. Approximately 29% of patients (44 out of 154) responded to therapy compared to 23% of subjects (21 of 91) treated with the vehicle. The percentage of patients who responded to treatment was therefore similar in the two groups; however, if only corneal damage is considered, Ikervis has given significantly better results in terms of reduction of injuries than the vehicle. In patients treated with Ikervis, the levels of HLA-DR (a measure of eye cell inflammation) have also decreased compared to the dummy treatment.
What is the risk associated with Ikervis - Cyclosporine?
The most common side effects of Ikervis (which may affect more than 1 in 10 people) are pain and eye irritation; other side effects are increased tearing, ocular hyperaemia (redness of the eye) and erythema (redness) of the eyelids. These symptoms are usually of short duration and occur at the time of applying the eye drops. For the full list of all side effects reported with Ikervis, see the package leaflet. Ikervis should not be used in patients who have or suspect they have an infection in the eye or in the surrounding tissues. For the full list of limitations, see the package leaflet.
Why has Ikervis - Cyclosporine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis's benefits are greater than its risks and recommended that it be approved for use in the EU. Although Ikervis has not been shown to be more effective in improving vehicle symptoms such as discomfort and pain, it has nevertheless been shown to reduce inflammation and corneal injury associated with keratitis. The CHMP considered this to be a clinically significant benefit, although none of the medicines available for this condition has been shown to reduce damage to the surface of the eye, which could help prevent disease progression. As for safety, the medicine was well tolerated and most of the short-term effects occurred at the time of applying the eye drops. The risk of systemic effects on the organism was considered low
What measures are being taken to ensure the safe and effective use of Ikervis - Cyclosporine?
A risk management plan has been developed to ensure that Ikervis is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ikervis, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Ikervis - Ciclosporina
On 19 March 2015, the European Commission issued a marketing authorization for Ikervis, valid throughout the European Union. For the full version of the EPAR and the summary of the Ikervis risk management plan, consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Ikervis therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 04-2015
