OZURDEX 700 micrograms intravitreal implant in applicator

Ozurdex is a rod-shaped implant that is injected into the eye. Each implant is provided in an applicator and contains 700 micrograms of the active substance, dexamethasone.

Ozurdex is used to treat adults (aged 18 years or over) with macular oedema (swelling in the macula, the central part of the retina at the back of the eye) caused by veins at the back of the eye becoming blocked. Macular oedema can reduce the central part of a person?s vision and affect tasks such as reading and driving.

The medicine can only be obtained with a prescription.

Ozurdex must be given by a qualified ophthalmologist (eye specialist) who has experience in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).

Patients receive one Ozurdex implant at a time, injected directly into the vitreous humour. Further treatments can be given if the patient?s vision improves initially but later gets worse and if the doctor believes that the patient will benefit from further treatment. Patients whose vision gets better and stays better should not receive any more implants. Patients whose vision is getting worse and is not improved by Ozurdex should also not receive any more implants.

The patient?s eye should be numbed with an anaesthetic before the implant is injected. Patients should also receive antibiotics before and after injection and they should be monitored after the injection to check for infection or raised eye pressure. For further information, see the summary of product characteristics (also part of the EPAR).

The active substance in Ozurdex, dexamethasone, belongs to a group of anti-inflammatory medicines known as corticosteroids. It works by entering 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 humour of the eye. This ensures that adequate amounts of dexamethasone reach the area inside the eye where the swelling in macular oedema occurs. The implant is made of a material that dissolves over several months while gradually releasing the dexamethasone.

The effects of Ozurdex were first tested in experimental models before being studied in humans. Because dexamethasone has been used as an anti-inflammatory for a number of years, the company also presented information from the published literature.

Ozurdex was studied in two main studies involving a total of 1,267 adults with macular oedema. The patients were given an Ozurdex implant or they received a ?sham? treatment where an applicator was pressed against their eye but nothing was actually injected. The main measure of effectiveness was the number of patients whose ?best corrected visual acuity? (BCVA) had improved enough after 90 or 180 days so that they could read at least 15 more letters in a standard eye test. BCVA is how well a person can see after they have been given appropriate corrective lenses.

Ozurdex was more effective than the sham treatment at improving the eyesight of patients with macular oedema. In the first study, around 23% of the patients receiving Ozurdex had an increase in BCVA of at least 15 letters after 180 days compared with 17% of the patients receiving the sham treatment. In the second study, the figures were around 22% for Ozurdex after 90 days and 12% for the sham treatment.

The most common side effects with Ozurdex (seen in more than 1 patient in 10) are increased intraocular pressure (the pressure inside the eye) and conjunctival haemorrhage (bleeding from the membrane that lines the front of the eye). The bleeding is thought to be caused by the injection procedure and not by the medicine itself. 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 must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes). It must also not be used in patients with glaucoma (a disease in which the pressure inside the eye rises because fluid cannot drain out of the eye) that is not adequately controlled with medicines.

Ozurdex Page

The CHMP noted that Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable. In addition, injections do not need to be given frequently because 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 authorisation.