What is Ozurdex?
Ozurdex is a cylinder-shaped implant that is injected into the eye. Each implant is supplied in an applicator and contains 700 micrograms of the active ingredient, dexamethasone.
What is Ozurdex used for?
Ozurdex is indicated for the treatment of adults (aged 18 years or older) with macular edema (swelling in the macula, the central portion of the retina in the inner part of the eye) due to an occlusion of the veins located in the posterior zone of the 'eye. Macular edema can reduce the central part of the view and influence activities such as reading and driving.
The medicine can only be obtained with a prescription.
How is Ozurdex used?
Ozurdex should be administered by a qualified ophthalmologist, experienced in intravitreal injections (injections made in the vitreous humor, the gelatinous fluid contained in the eye).
Ozurdex implants are applied one at a time, by injection directly into the vitreous humor. Further treatments can be performed in case of reduced vision, after an initial improvement, and if in the doctor's opinion the patient will benefit from reprocessing. Patients in whom vision improvement occurs and should not continue are not given other implants. Treatment should not be repeated even in patients who show deterioration of vision not improved by Ozurdex.
The patient's eye must be anesthetized before the implant is injected. Furthermore, patients should take antibiotics before and after the injection and should be monitored after the injection to check for the development of an infection or an increase in eye pressure. For more information, please refer to the summary of product characteristics (included with EPAR).
How does Ozurdex work?
The active substance in Ozurdex, dexamethasone, belongs to a group of anti-inflammatory medicines called corticosteroids. It works by penetrating cells and blocking the production of vascular endothelial growth factor (VEGF) and prostaglandins, substances that are involved in inflammation and swelling.
Ozurdex implants are injected directly into the vitreous humor of the eye, thereby ensuring that an adequate amount of dexamethasone reaches the ocular area affected by macular edema. The implant consists of a material that dissolves over several months, gradually releasing dexamethasone.
What studies have been carried out on Ozurdex?
The effects of Ozurdex were first tested in experimental models before being studied in humans. Since dexamethasone has been used for years as an anti-inflammatory, the company also presented data from the published literature.
Ozurdex has been the subject of two main studies involving a total of 1 267 adults with macular edema. Patients received an Ozurdex implant or underwent a simulation procedure, during which an applicator was pressed against the eye without an injection being performed. The main efficacy parameter was the number of patients whose "best corrected visual acuity" (BCVA), after 90 or 180 days, presented an improvement that would allow reading at least 15 more letters in a standard eye exam. The BCVA indicates the visual ability achieved by a subject with appropriate corrective lenses.
What benefit has Ozurdex shown during the studies?
Ozurdex has shown greater efficacy in improving vision in patients with macular edema than simulation treatment. In the first study, the percentage of patients treated with Ozurdex who had a BCVA increase of at least 15 letters after 180 days was approximately 23%, compared with 17% of patients who underwent the simulation procedure. In the second study, this percentage was around 22% in the Ozurdex group, after 90 days, and 12% in the simulation procedure group.
What are the risks associated with Ozurdex?
The most common side effects associated with Ozurdex (seen in more than 1 patient in 10) are an increase in intraocular pressure (internal pressure of the eye) and conjunctival hemorrhage (loss of blood from the membrane that covers the anterior portion of the eye ), which is believed to be caused by the injection and not by the medicine. For the full list of all side effects reported with Ozurdex, see the Package Leaflet.
Ozurdex should not be used in people who may be hypersensitive (allergic) to dexamethasone or any of the other ingredients. It should not be used in the case of patients with ocular or periocular infections (concerning the internal or external part of the eyes) active or suspicious. It must also not be used for patients with glaucoma (a disease characterized by an increase in intraocular pressure caused by the inability of the fluid to escape) not adequately controlled with the use of medicines.
Why has Ozurdex been approved?
The CHMP noted that the injection of Ozurdex causes only minor trauma to the eyeball and that the increase in intraocular pressure is considered manageable. Furthermore, injections should not be made frequently as the implant remains in the eye for several months. Based on the results of the studies, the committee decided that Ozurdex's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Ozurdex
On 27 July 2010, the European Commission issued a marketing authorization valid for the entire European Union to Ozerdex to Allergan Pharmaceuticals Ireland. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Ozurdex can be found here. For more information about Ozurdex therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 06-2010
