GANFORT is a clear to slightly yellow eye drops solution. GANFORT contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml).
|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?|
GANFORT is used to reduce intraocular pressure (the pressure inside the eye). It is used in patients who have open angle glaucoma (a disease where the pressure in the eye rises because fluid can not drain out of the eye) and in patients with ocular hypertension (the pressure in the eye is higher than normal). GANFORT contains a combination of two substances, a beta-blocker (timolol) and a prostamide (bimatoprost). It is used in patients who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues on their own. GANFORT can only be obtained with a prescription.
Raised intraocular pressure causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, GANFORT reduces the risk of damage. GANFORT contains two active substances, bimatoprost and timolol, and these lower the pressure in the eye by different mechanisms. Bimatoprost is a prostamide, a substance related to prostaglandin F 2?that works by increasing the outflow of fluid from the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan. Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970?s.
Four studies were carried out, involving 1,964 patients, aged 25-87 years. In three of these studies, patients were treated either with GANFORT once a day, or with eye drops containing only timolol or bimatoprost, for 3 months, followed by a further 9 months in two studies. In the fourth study, patients were treated with GANFORT or with timolol and bimatoprost given at the same time. All the studies measured how the intraocular pressure changed during the study. One study also looked at how many patients had an intraocular pressure below 18 mmHg (the pressure is measured in mmHg ? in a patient with glaucoma, the value is generally higher than 21 mmHg).
Overall, the studies showed that GANFORT is effective in lowering intraocular pressure. The values were lowered by about 8-10 mmHg. GANFORT was more effective than timolol on its own, and as effective as bimatoprost on its own. When looking at two of the studies together, where GANFORT was compared with its components given as separate drops (1,061 patients), and at patients whose pressure was not controlled with eye drops containing prostaglandins only (about a third of them), the medicine was more effective than bimatoprost on its own. GANFORT lowered the pressure to less than 18 mmHg in 18.7% of these patients, against 10.2% with bimatoprost only, and more patients had a drop in pressure of more than 20% in comparison to the pressure before the study (67.9% against 48.9%). In addition, GANFORT was shown to be as effective as bimatoprost and timolol given at the same time.
The most common side effects (seen in more than 1 patient in 10) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye) and growth of eyelashes. For the full list of all side effects reported with GANFORT, see the Package Leaflet.
GANFORT should not be used in people who may be hypersensitive (allergic) to bimatoprost, timolol or any of the other ingredients, in patients who have asthma or severe lung disease, or in patients with some heart conditions. See the Package Leaflet for the full list of restrictions.
GANFORT contains benzalkonium chloride, and care should be taken by people who wear soft contact lenses as it can discolour them. GANFORT may cause a darkening of the eyelid or of the iris of the eye.
The Committee for Medicinal Products for Human Use (CHMP) concluded that GANFORT has shown that it is effective, and that it can provide a benefit in improving compliance in patients who do not respond to single component eye drops. They decided that GANFORT?s benefits are greater than its risks for the treatment of open-angle glaucoma or ocular hypertension in patients who do not respond sufficiently to topical beta-blockers or prostaglandin analogues. They recommended that GANFORT be given marketing authorisation.