Nevanac

nepafenac

This is a summary of the European public assessment report (EPAR) for Nevanac. 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 Nevanac.

What is Nevanac?

Nevanac is an eye drop suspension that contains the active substance nepafenac.

What is Nevanac used for?

Nevanac is used to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye. Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in diabetes patients.

The medicine can only be obtained with a prescription.

How is Nevanac used?

The dose of Nevanac is one drop into the affected eye(s) three times a day beginning one day before the cataract operation. Treatment is continued after the operation for up to 21 days when used to prevent pain and inflammation or up to 60 days when used to reduce the risk of macular oedema. An extra drop should be given 30 to 120 minutes before the operation begins. If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.

How does Nevanac work?

The active substance in Nevanac, nepafenac, is a ‘prodrug’ of amfenac. This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.

How has Nevanac been studied?

For the prevention and treatment of pain and inflammation, Nevanac has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery. One study compared Nevanac used once, twice or three times a day with placebo (dummy eye drops) in 220 patients. The other three studies, in a total of 981 patients, compared Nevanac used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac. The main measure of effectiveness was either the proportion of patients in whom treatment had been successful (with no or few signs of inflammation in the eye), or the proportion of patients whose treatment had failed (with signs of moderate or severe inflammation in the eye). These were measured two weeks after surgery.

For the reduction in the risk of macula oedema, Nevanac has been compared with placebo in one main study involving 263 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery. The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.

What benefit has Nevanac shown during the studies?

Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation. In the study comparing different doses, the patients using Nevanac three times a day had the lowest failure rate. When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo. In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.

In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema. 3.2% of patients taking Nevanac developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126).

What is the risk associated with Nevanac?

In studies with Nevanac, approximately 3% of patients experienced side effects, but none of them were serious. For the full list of all side effects reported with Nevanac, see the package leaflet.

Nevanac must not be used in people who are hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs. Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs. Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses. Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses during treatment with Nevanac.

Why has Nevanac been approved?

The CHMP decided that Nevanac’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Nevanac

The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.

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

This EPAR was last updated on 09/02/2012 .

More detail is available in the Summary of Product Characteristics

Product details

Publication details

Product information

22/12/2011  Nevanac -EMEA/H/C/000818 -II/0007/G

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.

Pharmaco-therapeutic Group

Ophthalmologicals

Therapeutic Indication

Nevanac is indicated for:

• Prevention and treatment of postoperative pain and inflammation associated with cataract surgery
• Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.

Changes since initial authorisation of medicine

Initial Marketing authorisation documents