JETREA 0.375 mg/0.3 mL solution for injection

Ocriplasmin

Jetrea contains the active substance ocriplasmin.

Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).

VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present, which may decrease the symptoms caused by VMT.

Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving injections into the eye.

Jetrea is given as a single injection into the affected eye. The recommended dose is 0.125 mg.

Your doctor/ophthalmologist may ask you to use antibiotic eye drops before and after the injection in order to prevent any possible eye infection.

On the day of the injection, your doctor/ophthalmologist will use antimicrobial eye drops and clean your eye and eyelid carefully to prevent infection. Your doctor/ophthalmologist will also give you a local anaesthetic to prevent any pain from the injection.

After the injection, your doctor/ophthalmologist will monitor your vision.

If you have any further questions on the use of this medicine, ask your doctor/ophthalmologist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor/ophthalmologist immediately if you develop any of the following symptoms after injection of Jetrea. Your doctor/ophthalmologist will monitor you and take corrective measures if needed.

• A severe decrease in vision has been reported in up to 1 in 10 patients within one week after Jetrea treatment. This is generally reversible and will usually disappear without treatment.
• Symptoms such as eye pain, worsening eye redness, severely blurred or decreased vision, increased sensitivity to light or increased number of dark floating spots in the field of vision (floaters) are also seen in up to 1 in 10 patients and may be the signs of an infection, bleeding, separation or tear of the retina or an increase in the pressure inside the treated eye.
• Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.

Talk to your doctor/ophthalmologist if you develop any of the additional side effects listed below:

Very common side effects (may affect more than 1 in 10 patients):

• dark floating spots in the field of vision (floaters)
• eye pain
• bleeding on the surface of the eye
• colour vision changes

Common side effects (may affect up to 1 in 10 patients):

• decreased vision which may be severe
• visual disturbances
• decreased vision or blind spots in parts of the field of view
• blurred vision
• bleeding inside the eye
• blind spot or blind area in the centre of the vision
• distorted vision
• swelling of the surface of the eye
• swelling of the eyelid
• inflammation of the eye
• flashes of light in the eye
• eye redness
• irritation on the surface of the eye
• dry eye
• a feeling of having something in the eye
• itching of the eye
• eye discomfort
• sensitivity to light
• increased tear production

Uncommon side effects (may affect up to 1 in 100 patients):

• transient severe decreased vision
• difficulty in seeing well at night or in dim light
• disturbance in your eye’s reaction to the light that may increase your sensitivity to light (pupillary reflex impaired)
• double vision
• accumulation of blood in the front part of the eye
• abnormal constriction of the pupil (black part in the centre of the eye)
• different sized pupils
• a scratch or scrape of the cornea (transparent layer that covers the front of the eye)

Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea administration. Your doctor will be aware of this and will take it into account when monitoring your eye.

Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.

Keep this medicine out of the sight and reach of children.

Information about storage and the time to use Jetrea once it has been thawed are described in the section intended for healthcare professionals only.

Your ophthalmologist/doctor or pharmacist is responsible for storing this medicine and disposing of any unused solution correctly.