Eylea

aflibercept

This is a summary of the European public assessment report (EPAR) for Eylea. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eylea.

What is Eylea?

Eylea is a solution for injection into the eye that contains the active substance aflibercept. It is available as a prefilled syringe or as a vial.

What is Eylea used for?

Eylea is used to treat adults with the ‘wet’ form of age-related macular degeneration (AMD), a disease that affects the central part of the retina (called the macula) at the back of the eye. The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces. The wet form of AMD is caused by the abnormal growth of blood vessels under the macula, which may leak fluid and blood and cause swelling. This causes the gradual loss of the central part of a person’s vision.

The medicine can only be obtained with a prescription.

How is Eylea used?

Eylea must be given as an injection into the affected eye by a qualified doctor who is experienced in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).

One injection of 2 mg is given every month for three consecutive months, followed by one injection every two months. After one year of treatment, injections may be given less frequently depending on the response to treatment.

The procedure should be carried out under sterile conditions. The syringe and the vial are for single use only. The prefilled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume and ensure the injection of the correct dose. After the injection, the pressure within the eye should be checked.

How does Eylea work?

Aflibercept is an engineered protein that has been designed to attach to and block the effects of a substance called vascular endothelial growth factor A (VEGF-A). It can also attach to other proteins such as placental growth factor (PlGF). VEGF-A and PlGF are involved in stimulating the abnormal growth of blood vessels in patients with AMD. By blocking these factors, aflibercept reduces the growth of the blood vessels and controls the leakage and swelling.

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

How has Eylea been studied?

The effects of Eylea were first tested in experimental models before being studied in humans.

Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD. The studies compared Eylea (given either as 0.5 mg every four weeks, 2 mg every four weeks or 2 mg every eight weeks, all after three initial monthly doses) with ranibizumab, another treatment for AMD which is given by injection into the eye every four weeks. The main measure of effectiveness was the proportion of patients who maintained vision (defined as losing less than 15 letters in a standard eye test) after the first year of treatment.

Both studies also looked at the maintenance of the effect in the second year of treatment, during which the number of injections and the time between injections were adjusted depending on the vision and changes within the eye.

What benefit has Eylea shown during the studies?

Eylea was shown to be as effective as ranibizumab in maintaining vision: looking at the results of the two studies together, the proportions of patients who maintained vision were 96.1% (517 out of 538), 95.4% (533 out of 559) and 95.3% (510 out of 535) for 0.5 mg Eylea every four weeks, 2 mg Eylea every four weeks and 2 mg Eylea every eight weeks, respectively, compared with 94.4% (508 out of 538) of patients treated with ranibizumab every four weeks.

During the second year of treatment, the effectiveness was generally maintained, with a majority of patients receiving injections at an extended dosing interval of 10 weeks, although a small number of patients occasionally needed more frequent injections (such as monthly).

What is the risk associated with Eylea?

The most common side effects reported with Eylea are conjunctival haemorrhage (bleeding at the front of the eye, 26.7%), eye pain (10.3%), vitreous detachment (detachment of the jelly-like substance inside the eye, 8.4%), cataract (clouding of the lens, 7.9%), vitreous floaters (small particles or spots in the vision, 7.6%) and increased intraocular pressure (increased pressure inside the eye, 7.2%). Serious side effects (seen in less than 1 in 1,000 patients) can occur after Eylea injection, including endophthalmitis (an infection inside the eye), traumatic cataract (clouding of the lens due to injury) and temporarily increased intraocular pressure. For the full list of all side effects reported with Eylea, see the package leaflet.

Eylea must not be used in people who are hypersensitive (allergic) to aflibercept 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), or in patients who have severe inflammation inside the eye.

Why has Eylea been approved?

The CHMP noted that Eylea was as effective as ranibizumab in maintaining patients’ vision after the first year of treatment. As the effectiveness of Eylea was similar for the different dosing regimens evaluated, the CHMP recommended that, after the first three monthly injections, Eylea be given every eight weeks during the first year of treatment. However, the optimal dose and interval between doses required to maintain the benefit obtained after the first year of treatment remain uncertain. The CHMP further noted that there were no major or unexpected safety concerns with Eylea. Therefore, the CHMP decided that Eylea’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Eylea?

The company that makes Eylea will provide educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor). In addition, the company will carry out a study to establish the optimal dosing regimen after the first year of treatment, in order to maintain the initial improvement in vision.

Other information about Eylea

The European Commission granted a marketing authorisation valid throughout the European Union for Eylea on 22 November 2012.

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

This EPAR was last updated on 05/12/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

22/11/2012  Eylea -EMEA/H/C/002392 --

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.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Eylea is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Changes since initial authorisation of medicine

Initial marketing-authorisation documents