Characteristics of the medicinal product
DuoTrav is an eye drop that comes in the form of a transparent solution. DuoTrav contains two
active ingredients: travoprost (40 micrograms / ml) and timolol (5 mg / ml).
Therapeutic indications
DuoTrav is used to reduce intraocular pressure (pressure inside the eye, IOP-IntraOcular Pressure). It is used in patients who have open-angle glaucoma (a disease that causes increased pressure inside the eye due to the inability to drain the fluid) and in patients with ocular hypertension (ie with an internal pressure of the eye above the norm). DuoTrav contains a combination of drugs, a beta-blocker (timolol) and a prostaglandin analogue (travoprost), and is used in patients who do not respond sufficiently to eye drops containing only beta-blockers or only prostaglandin analogues. DuoTrav can only be obtained with a prescription.
Method of use
The dose to be used is a drop of DuoTrav in the affected eye or in the affected eyes
once a day, in the morning or evening. The eye drops must be applied at the same time every day. DuoTrav is not recommended for patients under the age of 18.
Mechanisms of action
Elevation of IOP causes damage to the retina (the light-sensitive membrane located at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can cause severe vision loss and even blindness. By lowering the IOP, DuoTrav reduces the risk of eye damage. DuoTrav contains two active ingredients: travoprost and timolol. These two drugs lower the pressure in the eye with distinct mechanisms. Travoprost is a prostaglandin analogue that works by increasing the flow of fluid from the eye. Travoprost alone has already obtained marketing approval in the European Union under the name of TRAVATAN.
Timolol is a beta-blocker that works by reducing the production of fluid inside the eye. Timolol has been used since the 1970s in the treatment of glaucoma. The combined effect of the two substances produces a greater reduction in IOP than that determined by the two drugs used alone.
Studies carried out
Five clinical studies were conducted on 1, 499 patients with increased IOP caused by open-angle glaucoma or ocular hypertension. These studies included patients aged between 18 and 91 years (half of whom were elderly subjects) and had a duration of between 6 weeks and 12 months. DuoTrav was studied administering it at different times of the day (morning or evening), comparing it with each of the two individual components and administering the two components in the form of separate eye drops. The 12-month study compared DuoTrav with an eye drop containing a combination of latanoprost (a prostaglandin analogue) and timolol. The IOP average at different times represented the main parameter for the evaluation of efficacy (IOP is measured in mmHg; in a patient with glaucoma its value is generally higher than 21 mmHg).
Benefits found following the studies
DuoTrav reduced IOP in all studies: the average reduction obtained was around 8-10 mmHg, more or less a third less than the pre-treatment value. DuoTrav was more effective in reducing IOP than just timolol or TRAVATAN alone. DuoTrav was as effective as the two drugs given in the form of separate eye drops and how much the eye drops containing both latanoprost and timolol.
Associated risks
The most common side effect (found in 15% of patients in clinical trials) is ocular hyperemia (increased blood flow to the eye, which causes eye irritation and redness). For the complete list of side effects reported with the use of DuoTrav, see the package leaflet.
DuoTrav should not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and other beta-blockers) or to any of the other ingredients. DuoTrav should not be used in people with asthma or severe lung disease, or in subjects with heart problems. For a complete list of usage restrictions, see the package insert.
DuoTrav contains benzalkonium chloride, a substance that can bleach soft contact lenses.
A certain caution is therefore necessary in subjects who wear soft contact lenses. DuoTrav can cause a change in color of the iris (which tends to darken) and thickening, darkening or lengthening of the eyelashes.
Grounds for approval
DuoTrav is a combination of travoprost and timolol at fixed doses which can improve IOP control. Its effectiveness is superior to the two components taken individually and equivalent to the two components administered together, but in the form of two distinct eye drops. The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of DuoTrav outweigh its risks in the treatment of open-angle glaucoma or ocular hypertension in patients who do not respond sufficiently to beta-blockers or analogues of prostaglandins for topical use. Therefore, the committee recommended that DuoTrav be given marketing authorization.
Further information
On 24 April 2006, the European Commission granted a marketing authorization valid for DuoTrav, valid throughout the European Union, to Alcon Laboratories (UK) Limited.
For the full version of the evaluation (EPAR) of DuoTrav, click here.
Last update of this summary: March 2006.
