GANFORT - eye drops

Characteristics of the medicinal product

GANFORT is an eye drop that comes in the form of a colorless to slightly yellow solution. THE

there are two active ingredients: bimatoprost (0.3 mg / ml) and timolol (5 mg / ml).

Therapeutic indications

GANFORT is used to reduce intraocular pressure (inside the eye) in patients with open-angle glaucoma (a disease in which the impossibility of fluid outflow outside the eye causes an increase in intraocular pressure) or with hypertension ocular (intraocular pressure higher than normal). GANFORT contains a combination of two substances, a beta-blocker (timolol) and a prostamide (bimatoprost) and is used in patients who do not respond adequately to treatment with eye drops containing, alternatively, beta-blockers or prostaglandin analogues. The medicine can only be obtained with a prescription.

Method of use

GANFORT is given in the affected eye in a drop of once a day, in the morning.

Mechanisms of action

The increase in intraocular pressure causes damage to the retina (the light-sensitive membrane located behind the eye) and to the optic nerve (which sends signals from the eye to the brain), with possible severe lowering of vision or even blindness. GANFORT reduces the risk of such damage by lowering the pressure. The two active ingredients of GANFORT, bimatoprost and timolol, reduce intraocular pressure by acting differently. Bimatoprost is a prostamide, a substance linked to prostaglandin F2 which increases the flow of fluids contained in the eye. Bimatoprost administered on its own has already received marketing authorization in the European Union under the name Lumigan. Timolol is a beta-blocker that reduces fluid production within the eye and is commonly used in the treatment of glaucoma since the 1970s.

Studies carried out

Four studies were conducted on a total of 1964 patients aged between 25 and 87 years. In three of these studies the patients were treated for 3 months with GANFORT once daily or with eye drops containing alternatively timolol or bimatoprost; in two of these studies the treatment was prolonged for another 9 months. In the fourth study, patients were treated with GANFORT or with timolol and bimatoprost in combination. The parameter evaluated in all studies was the change in intraocular pressure during the course of the study. One study also recorded the number of patients with intraocular pressure less than 18 mmHg (pressure is measured in mmHg; in patients with glaucoma this value is generally higher than 21 mmHg).

Benefits found following the studies

Overall, studies have shown the effectiveness of GANFORT in reducing intraocular pressure, with a decrease of about 8-10 mmHg. The efficacy of GANFORT was higher than that of timolol taken alone and equal to that of bimatoprost taken alone. If we consider together the two studies that compared GANFORT and the two active ingredients taken separately (1061 patients) and patients with uncontrolled eye drops containing only prostaglandins (about a third of them), we observe that the drug was more effective than bimatoprost taken alone. GANFORT succeeded in lowering the pressure to less than 18 mmHg in 18.7% of these patients, compared to 10.2% in bimatoprost alone; moreover, it allowed to obtain a pressure decrease of more than 20% compared to the pre-study pressure in 67.9% of patients, against 48.9% of patients treated only with bimatoprost. GANFORT is also effective as a combination of bimatoprost and timolol.

Associated risks

The most common side effects, that is observed in more than one patient in 10, are conjunctival hyperemia (increased blood flow to the eye, which causes redness) and lengthening of the eyelashes. For the full list of all side effects reported with GANFORT, see the Package Leaflet.

GANFORT should not be used in patients who are potentially hypersensitive (allergic) to bimatoprost, timolol or any other component, asthmatic patients or those with serious lung disease or suffering from certain heart conditions. For the complete list of limitations, see the package insert.

Because GANFORT contains benzalkonium chloride, wearers of soft contact lenses should be careful as they may discolor. GANFORT can cause browning of the eyelids or iris.

Grounds for approval

The Committee for Medicinal Products for Human Use (CHMP) concluded that GANFORT has been shown to be effective and able to help improve compliance with the treatment regimen for patients who do not respond to eye drops with only one active ingredient. The CHMP therefore decided that the benefits of GANFORT outweigh the risks in the treatment of open-angle glaucoma and ocular hypertension in patients who do not respond satisfactorily to beta-blockers or topical prostaglandin analogues and therefore recommended the release

of the marketing authorization for GANFORT.