Lucentis

Lucentis is available as an injection in prefilled syringes or vials, for single use. It is given by intravitreal injection (injection into the vitreous humour, the jelly-like fluid in the eye). It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.

In adults, the recommended dose for Lucentis is 0.5 mg given as a single injection. The interval between two injections of Lucentis into the same eye must be at least four weeks.

Treatment with Lucentis is started with one injection every month, with regular checks of the patient’s vision and examination of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity. Treatment with Lucentis should be stopped if the patient is not benefitting from it.

In preterm infants, the recommended dose is 0.2 mg per eye which can be given in both eyes on the same day. In total, up to three injections per eye can be given within 6 months, depending on the signs of disease activity. The interval between two doses injected into the same eye should be at least four weeks.

For more information about using Lucentis, see the package leaflet or contact your doctor or pharmacist.

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

Ranibizumab has been designed to attach to and 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, damaging the macula. By blocking VEGF-A, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.

AMD

Three main studies of Lucentis involved 1,323 patients with the wet form of AMD. 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 (a procedure similar to a Lucentis injection, in which the syringe is pressed against the surface of the eye but no actual injection is carried out). The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD). Patients were classified as having no significant worsening of vision if the number of letters that they could recognise on a standard eye test increased, stayed the same, or fell by less than 15 after a year of treatment.

Lucentis was more effective at preventing a worsening of vision than the comparison treatment. After one year, between 94 and 96% of the patients receiving Lucentis every month had 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.

Diabetic macular oedema

For diabetic macular oedema, Lucentis was studied for one year in two main studies involving a total of 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.

Lucentis was more effective at improving vision than its comparison treatments. In the first study, patients receiving Lucentis could recognise about 6 letters more on a standard eye test than those receiving sham injections. In the second study, patients receiving Lucentis on its own or as an add?on to laser photocoagulation could recognise an average of 5 letters more than patients receiving laser photocoagulation on its own.

Macular oedema due to occlusion of retinal veins

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. The main measure of effectiveness was the change in the number of letters that the patient could recognise at the end of treatment compared with the number of letters before starting treatment.

Lucentis was more effective than a sham injection: patients receiving Lucentis for six months could recognise around 11 letters more than patients receiving a sham injection in one study and 14 letters more in the other study.

Proliferative diabetic retinopathy

In a study with 394 patients with proliferative diabetic retinopathy who received either laser treatment (panretinal photocoagulation) or Lucentis, patients receiving Lucentis could recognise about 3.5 letters more on a standard eye test than those receiving laser treatment, after 2 years.

Choroidal neovascularisation

For choroidal neovascularisation not associated with wet AMD, Lucentis has been studied in 2 main studies each lasting a year. One study compared Lucentis with verteporfin PDT in 277 patients with choroidal neovascularisation associated with pathologic myopia (a severe type of short sightedness). Over the first 3 months of treatment, patients given Lucentis could recognise on average around 8 to 9 letters more on a standard eye test than those receiving verteporfin PDT.

A second study involving 178 patients with choroidal neovascularisation associated with other conditions compared Lucentis with a sham injection. After 2 months of treatment, patients given Lucentis could recognise on average around 10 letters more on a standard eye test than those given sham treatment.

In both studies, the improvement in vision was maintained over the course of the study.

Retinopathy of prematurity

Lucentis was studied in preterm infants with retinopathy of prematurity who received either up to 3 injections of Lucentis in each eye or laser therapy.

After about 6 months of treatment, 80% of patients (56 out of 70) who received Lucentis at a dose of 0.2 mg had no signs of disease or structural abnormalities in the eyes compared with 66% of patients (45 out of 68) who received laser treatment.

The most common side effects with Lucentis (which may affect more than 1 in 10 people) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous 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 (watery eyes), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (increased blood supply to the eye, leading to redness of the eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat). Rarely, endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and cataract (clouding of the lens) can occur. For the full list of side effects of Lucentis, see the package leaflet.

Lucentis must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation within the eye. For the full list of restrictions, see the package leaflet.

In patients with AMD, Lucentis is effective at preventing a worsening of vision. In the treatment of choroidal neovascularisation, diabetic macular oedema and proliferative diabetic retinopathy Lucentis is effective at improving patients’ vision. In preterm infants with retinopathy, the disease resolved after treatment with Lucentis. In terms of safety, side effects with Lucentis were generally manageable and not serious. The European Medicines Agency therefore decided that Lucentis’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Lucentis will provide the results of an ongoing study with Lucentis in infants with retinopathy of prematurity to confirm the benefits of treatment.

The company will also provide information packs to adult patients to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lucentis have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lucentis are continuously monitored. Side effects reported with Lucentis are carefully evaluated and any necessary action taken to protect patients.

Lucentis received a marketing authorisation valid throughout the EU on 22 January 2007.