What is Oxervate - Cenegermin used for and what is it used for?
Oxervate is a medicine used to treat neurotrophic keratitis, an eye disease in which damage to the trigeminal nerve that supplies the surface of the eye causes loss of sensation and lesions that do not heal naturally.
The medicine is used only in adults with moderate or severe disease.
Because the number of patients suffering from neurotrophic keratitis is low, the disease is considered "rare" and Oxervate was qualified as an "orphan medicine" (a medicine used in rare diseases) on December 14, 2015.
Oxervate contains the active substance cenegermin.
How is Oxervate - Cenegermin used?
Oxervate is available in the form of eye drops. The recommended dose is 1 drop in the affected eye every 2 hours, 6 times a day. Treatment should be continued for 8 weeks.
Oxervate can only be obtained with a prescription and treatment must be started and supervised by an ophthalmologist.
For more information, see the package leaflet.
How does Oxervate - Cenegermin work?
Patients suffering from neurotrophic keratitis present lower levels than the norm of substances including growth factors that are normally supplied by the trigeminal nerve and that play an important role in the growth and survival of cells on the surface of the eye. The active substance in Oxervate, cenegermin, is a copy of a human growth factor called a nerve growth factor. When administered in the form of eye drops to patients with neurotrophic keratitis, cenegermin helps to restore some of the normal healing processes of the eye and repair the damage to the surface of the eye.
What benefit has Oxervate - Cenegermin shown during the studies?
Oxervate has been shown to help heal eye surface damage in 2 main studies involving a total of 204 adults with moderate or severe neurotrophic keratitis. In the first study, 74% (37 out of 50) of patients treated with Oxervate for 8 weeks achieved a complete healing of the eye surface compared to 43% (22 of 51) of patients undergoing a dummy treatment containing the same eye drops but without active ingredient. In the second study, the results were 70% (16 of 23) with Oxervate and 29% (7 of 24) with the dummy treatment.
What are the risks associated with Oxervate - Cenegermin?
The most common side effects of Oxervate (which may affect more than 1 in 100 people) are eye pain and inflammation, increased tearing (watery eyes), eyelid pain and a feeling of a foreign body in the eye.
For the full list of side effects and limitations of Oxervate, see the package leaflet.
Why has Oxervate - Cenegermin been approved?
Oxervate has been shown to increase the number of patients achieving complete healing of the eye surface by about 30-40% compared to eye drops without active ingredient. The side effects of Oxervate mainly concern the eye, are mild or moderate and resolve over time.
The European Medicines Agency has therefore decided that Oxervate's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Oxervate - Cenegermin?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oxervate have been included in the summary of product characteristics and the package leaflet.
More information on Oxervate - Cenegermin
For the full version of EPAR and the Oxervate risk management plan summary, refer to the Agency website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Oxervate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products concerning Oxervate is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / Rare disease designation.
