What is Ozurdex?
Ozurdex is a barrel-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 and 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 back of the eye. "eye." Macular edema can reduce central vision and affect activities such as reading and driving.
The medicine can only be obtained with a prescription.
How is Ozurdex used?
Ozurdex must be administered by a qualified ophthalmologist experienced in intravitreal injections (injections given into the vitreous humor, the jelly-like fluid contained in the eye).
The implants of Ozurdex are applied one at a time, by injection directly into the vitreous humor. Further treatments can be carried out in case of decreased vision, after an initial improvement, and if in the opinion of the doctor the patient will benefit from a retreatment. No other implants should be given to patients in whom vision improvement occurs and persists, and treatment should not be repeated even in patients who show visual impairment not improved by Ozurdex.
The patient's eye should be anesthetized before the implant is injected. In addition, patients should take antibiotics before and after the injection and should be monitored after the injection to check for any development of an infection or increase. eye pressure. For more information, see the Summary of Product Characteristics (attached to the 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 is made up of a material that dissolves over the course of several months, gradually releasing dexamethasone.
How has Ozurdex been studied?
The effects of Ozurdex were first tested in experimental models before being studied in humans. Since dexamethasone has been in use for years as an anti-inflammatory, the company also presented data from the published literature.
Ozurdex has been studied in two main studies involving a total of 1,267 adults with macular edema. Patients either received an Ozurdex implant or underwent a sham procedure, in which an applicator was pressed against the eye without an injection being given. The main measure of effectiveness was the number of patients whose "best corrected visual acuity" (BCVA), after 90 or 180 days, improved enough to allow reading at least 15 more letters in a standard eye exam. BCVA indicates the vision achieved by a subject with appropriate corrective lenses.
What benefit has Ozurdex shown during the studies?
Compared to the sham treatment, Ozurdex showed greater efficacy in improving the vision of patients with macular edema. In the first study, the percentage of patients treated with Ozurdex who had an increase in BCVA of at least 15 letters after 180 days was approximately 23%, compared with 17% of patients undergoing the sham procedure. In the second study, this percentage was approximately 22% in the Ozurdex group, after 90 days, and 12% in the sham procedure group.
What are the risks associated with Ozurdex?
The most common side effects associated with Ozurdex (seen in more than 1 in 10 patients) are an increase in intraocular pressure (internal pressure of the eye) and conjunctival haemorrhage (bleeding from the membrane that lines the front of the eye). , which is thought to be caused by the injection and not by the medicine. For the full list of side effects reported with Ozurdex, see the package leaflet.
Ozurdex must not be used in people who may be hypersensitive (allergic) to dexamethasone or any of the other ingredients. It should not be used in patients with active or suspected ocular or periocular infections (concerning the inner or outer part of the eyes). It should 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) that is 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 globe and that the increase in intraocular pressure is considered manageable. Also, injections do not have to be done frequently as the implant stays 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.
Learn more about Ozurdex
On July 27, 2010, the European Commission granted Allergan Pharmaceuticals Ireland a "Marketing Authorization" for Ozurdex, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For the full Ozurdex EPAR, click here. For more information about Ozurdex therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 06-2010
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