|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
NEVANAC is used to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.
The medicine can only be obtained with a prescription.
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 for two to three weeks after the operation. 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.
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 the inflammation and pain caused by eye surgery.
The effects of NEVANAC were first tested in experimental models before being studied in humans. The effectiveness of 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.
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.
The most common side effects with NEVANAC (seen in between 1 and 10 patients in 100) are headache, punctate keratitis (spots of inflammation in the cornea, the transparent layer in front of the pupil), eye pain, blurred vision, eye pruritis (itching), dry eye, a sensation of a foreign body in the eyes and crusting at the edge of the eyelid. Similar side effects were seen in patients using placebo or ketorolac eye drops. For the full list of all side effects reported with NEVANAC, see the Package Leaflet.
NEVANAC should not be used in people who may be hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs. Like other NSAIDs, NEVANAC should 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. Therefore, care should be taken by people who wear soft contact lenses.
The Committee for Medicinal Products for Human Use (CHMP) decided that NEVANAC?s benefits are greater than its risks for prevention and treatment of postoperative pain and inflammation associated with cataract surgery. The Committee recommended that NEVANAC be given marketing authorisation.