Lucentis

Active Substance: ranibizumab
Common Name: ranibizumab
ATC Code: S01LA04
Marketing Authorisation Holder: Novartis Europharm Ltd.
Active Substance: ranibizumab
Status: Authorised
Authorisation Date: 2007-01-22
Therapeutic Area: Wet Macular Degeneration Macular Edema Diabetes Complications
Pharmacotherapeutic Group: Ophthalmologicals

Therapeutic Indication

Lucentis is indicated in adults for:

• the treatment of neovascular (wet) age-related macular degeneration (AMD);
• the treatment of visual impairment due to diabetic macular oedema (DME);
• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) (branch RVO or central RVO).

What is Lucentis?

Lucentis is a solution for injection into the eye. It contains the active substance ranibizumab.

What is Lucentis used for?

Lucentis is used to treat adults with:

• the ‘wet’ form of age-related macular degeneration (AMD);
• macular oedema (swelling) caused by diabetes;
• macular oedema caused by occlusion (blockage) of the veins behind the retina.

These diseases affect 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, and damage to the macula cause loss of ‘straight-ahead’ vision. The diseases involve the leakage of fluid from blood vessels under the macula, causing swelling.

The medicine can only be obtained with a prescription.

How is Lucentis used?

Lucentis is given as an injection (0.5 mg) into the affected eye by a qualified ophthalmologist (eye specialist) who is experienced at giving this type of injection.

One injection is given every month until maximum vision is achieved and is stable for three consecutive months. The patient’s vision should be checked every month and treatment resumed if their vision worsens due to their disease.

The interval between two injections of Lucentis must always be at least one month. Before each injection, a local anaesthetic is given to reduce or prevent any pain from the injection, and the eye, eyelid and skin around the eye are disinfected. Antibiotic eye drops are given for three days before the injection and afterwards to prevent eye infection. Patients will be taught how to use the eye drops by themselves.

How does Lucentis work?

The active substance in Lucentis, ranibizumab, is a small piece of a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Ranibizumab has been designed to block a substance called vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that makes blood vessels grow and leak fluid and blood. These effects worsen the damage to the macula. By blocking this factor, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.

How has Lucentis been studied?

Three main studies of Lucentis involved 1,323 patients with the wet form of AMD. All of the patients were over 50 years of age and had not been treated for wet AMD before. Two of the studies compared Lucentis with a sham injection. This is a procedure that is similar to a Lucentis injection, but with no Lucentis and no needle, in which the syringe is pressed against the surface of the eye but no actual injection is carried out. The patients cannot tell whether they received Lucentis or the sham procedure. The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD). The main measure of effectiveness was the change in vision in the affected eye after a year of treatment, using a standard eye test with a letter chart. Patients were classified as having experienced no significant worsening of vision if the number of letters that they could see increased, stayed the same, or fell by less than 15.

For diabetic macular oedema, Lucentis was studied in two main studies involving at total 454 patients. The first study compared Lucentis with a sham injection. The second study compared Lucentis, given on its own or as an add-on to laser photocoagulation (a treatment for diabetic macular oedema using a laser), with laser photocoagulation on its own. For macular oedema due to retinal vein occlusion, Lucentis was looked at in two main studies involving a total of 789 patients, where Lucentis was compared with a sham injection. In all studies, the main measure of effectiveness was the change in vision in the affected eye, measured by comparing the number of letters that the patient could see at the end of the treatment period with the number before starting treatment.

What benefit has Lucentis shown during the studies?

In AMD, Lucentis was more effective at preventing a worsening of vision than its comparators. Between 94 and 96% of the AMD patients receiving Lucentis every month experienced no significant worsening of their vision, compared with 62% of those receiving sham injections and 64% of those treated with verteporfin PDT. The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.

In diabetic macular oedema, Lucentis was more effective at improving vision than its comparators. In the first study, after one year, patients receiving Lucentis could see about 6 letters more than those receiving sham injections. In the second study, patients receiving Lucentis on its own or as an add-on to laser photocoagulation could see after one year an average of 5 letters more than patients receiving laser photocoagulation on its own. In macular oedema due to retinal vein occlusion, Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in another study.

What is the risk associated with Lucentis?

The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the fluid in the eye from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat). For the full list of all side effects reported with Lucentis, see the package leaflet.

Rarely, endophthalmitis (an infection inside the eye), serious eye inflammation, damage to the retina and cataract (clouding of the lens) can occur after Lucentis treatment. It is important to treat these problems as soon as possible. Their symptoms and instructions about what to do if a patient has them are explained in the package leaflet. As injections into the eye can cause a temporary increase in the pressure within the eye, the ophthalmologist will check for this after the injection and take corrective measures if needed.

Lucentis must not be used in patients who are hypersensitive (allergic) to ranibizumab or any of the other ingredients. It must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye.

Why has Lucentis been approved?

The CHMP decided that Lucentis’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 Lucentis?

The company that makes Lucentis will provide all clinics where Lucentis is expected to be used with information packs for doctors (including information on the measures needed to minimise the risk of infection associated with injections into the eye) and packs for patients (to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor).

Other information about Lucentis:

The European Commission granted a marketing authorisation valid throughout the European Union for Lucentis on 22 January 2007.

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

Source: European Medicines Agency

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