Jetrea

ocriplasmin

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This is a summary of the European public assessment report (EPAR) for Jetrea. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Jetrea.

For practical information about using Jetrea, patients should read the package leaflet or contact their doctor or pharmacist.

What is Jetrea and what is it used for?

Jetrea is a medicine that contains the active substance ocriplasmin. It is used to treat adults with vitreomacular traction (VMT), an eye disease that can cause severe visual disturbance.

How is Jetrea used?

Jetrea is a concentrate that is made up into a solution for injection into the eye. It can only be obtained with a prescription and must be prepared and given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye). The concentrate is to be stored in the freezer and the procedure should be carried out under sterile conditions.

The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated. The other eye should not be treated with Jetrea for at least seven days.

The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections. Patients should be monitored after the injection to check for infection or raised eye pressure.

How does Jetrea work?

VMT is caused by vitreomacular adhesion (VMA), in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light-sensitive membrane at the back of the eye). When the vitreous humour shrinks with ageing, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.

The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.

The ocriplasmin in Jetrea is produced by a method known as ‘recombinant DNA technology’: it is made by yeast cells that have received a gene (DNA), which makes them able to produce ocriplasmin.

What benefits of Jetrea have been shown in studies?

Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.

In two main studies involving 652 adults with VMA and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment).

After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81). Successful treatment of VMA can help reverse disturbances of the vision caused by VMT, and prevent further loss of vision from untreated and progressive traction at the retina.

What are the risks associated with Jetrea?

The side effects seen with Jetrea affect the eye. The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain and photopsia (flashes of light in the field of vision), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye). For the full list of all side effects reported with Jetrea, see the package leaflet.

Jetrea must not be used in patients who have or are thought to have infections in or around the eyes. For the full list of restrictions, see the package leaflet.

Why is Jetrea approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU. Studies have shown that Jetrea was effective in treating VMA and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive VMT. Although the effects shown were modest (resolution of VMA in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery. Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself. The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.

What measures are being taken to ensure the safe and effective use of Jetrea?

A risk-management plan has been developed to ensure that Jetrea is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jetrea, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive an information pack containing key information on how to use the medicine as well as an information pack to be given to patients.

Other information about Jetrea

The European Commission granted a marketing authorisation valid throughout the European Union for Jetrea on 13 March 2013.

For more information about treatment with Jetrea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Jetrea : EPAR - Summary for the public BG = bălgarski 18/04/2013  
Jetrea : EPAR - Summary for the public ES = español 18/04/2013  
Jetrea : EPAR - Summary for the public CS = čeština 18/04/2013  
Jetrea : EPAR - Summary for the public DA = dansk 18/04/2013  
Jetrea : EPAR - Summary for the public DE = Deutsch 18/04/2013  
Jetrea : EPAR - Summary for the public ET = eesti keel 18/04/2013  
Jetrea : EPAR - Summary for the public EL = elliniká 18/04/2013  
Jetrea : EPAR - Summary for the public EN = English 18/04/2013  
Jetrea : EPAR - Summary for the public FR = français 18/04/2013  
Jetrea : EPAR - Summary for the public IT = italiano 18/04/2013  
Jetrea : EPAR - Summary for the public LV = latviešu valoda 18/04/2013  
Jetrea : EPAR - Summary for the public LT = lietuvių kalba 18/04/2013  
Jetrea : EPAR - Summary for the public HU = magyar 18/04/2013  
Jetrea : EPAR - Summary for the public MT = Malti 18/04/2013  
Jetrea : EPAR - Summary for the public NL = Nederlands 18/04/2013  
Jetrea : EPAR - Summary for the public PL = polski 18/04/2013  
Jetrea : EPAR - Summary for the public PT = português 18/04/2013  
Jetrea : EPAR - Summary for the public RO = română 18/04/2013  
Jetrea : EPAR - Summary for the public SK = slovenčina 18/04/2013  
Jetrea : EPAR - Summary for the public SL = slovenščina 18/04/2013  
Jetrea : EPAR - Summary for the public FI = suomi 18/04/2013  
Jetrea : EPAR - Summary for the public SV = svenska 18/04/2013  

This EPAR was last updated on 28/04/2014 .

Authorisation details

Product details

Product details for Jetrea
NameJetrea
Agency product numberEMEA/H/C/002381
Active substance

ocriplasmin

International non-proprietary name (INN) or common name

ocriplasmin

Therapeutic area Retinal Diseases
Anatomical therapeutic chemical (ATC) code S01
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Jetrea
Marketing-authorisation holder

ThromboGenics NV

Revision2
Date of issue of marketing authorisation valid throughout the European Union13/03/2013

Contact address:

Gaston Geenslaan 1
B-3001 Leuven
Belgium

Product information

Product information

20/03/2014  Jetrea -EMEA/H/C/002381 -II/0007

Name Language First published Last updated
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014
Jetrea : EPAR - Product Information SV = svenska 18/04/2013 28/04/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  
Jetrea : EPAR - All Authorised presentations SV = svenska 18/04/2013  

Pharmacotherapeutic group

ophthalmologicals

Therapeutic indication

Jetrea is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Jetrea : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 16/01/2014 28/04/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Jetrea : EPAR - Public assessment report SV = svenska 18/04/2013  
CHMP summary of positive opinion for Jetrea SV = svenska 18/01/2013  

Authorised

This medicine is approved for use in the European Union