What is TRAVATAN?
TRAVATAN is a clear solution of eye drops containing the active substance travoprost.
What is TRAVATAN used for?
TRAVATAN is indicated to reduce intraocular pressure (inside the eye). It is used in patients with open-angle glaucoma (a disease in which eye pressure increases because the liquid cannot flow out of the eye) and in patients with ocular hypertension (eye pressure above normal).
The medicine can only be obtained with a prescription.
How is TRAVATAN used?
The dosage is one drop of TRAVATAN in the affected eye (s) once a day, preferably in the evening. The use of TRAVATAN is not recommended in patients under the age of 18 years.
How does TRAVATAN work?
When the intraocular pressure increases, it causes damage to the retina (the light-sensitive membrane located at the back of the eye) and to the optic nerve (nerve used to send signals from the eye to the brain), causing severe vision loss. and even blindness. By lowering the pressure, TRAVATAN reduces the risk of injury. The active substance in TRAVATAN, travoprost, is an analogue of prostaglandins (an artificial copy of a natural substance, prostaglandin).
In the eye the prostaglandin increases the drainage of aqueous humor (transparent liquid present inside the eye) towards the outside. TRAVATAN acts in the same way, increasing the outflow of aqueous humor, thus reducing the pressure inside the eye.
How has TRAVATAN been studied?
TRAVATAN has been studied in 1 989 patients in three main studies, lasting 6-12 months. All three studies compared travoprost with timolol, the medicine commonly used in the treatment of glaucoma. One of the three studies also included a comparison with latanoprost (another prostagladin analogue used for the treatment of glaucoma). The main measure of effectiveness was the reduction of intraocular pressure. Another study compared the efficacy of TRAVATAN as an adjunctive therapy in the treatment of patients who already used timolol (427 patients, duration of 6 months).
What benefit has TRAVATAN shown during the studies?
TRAVATAN proved to be at least as effective as timolol and as effective as latanoprost in reducing intraocular pressure. Combined treatment with TRAVATAN and timolol induced a further decrease in intraocular pressure in patients not controlled with timolol alone.
What is the risk associated with TRAVATAN?
The most common side effects seen with the use of TRAVATAN (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood flow to the eye, which causes irritation and redness of the eye) and change of eyelashes, including increase in length, thickness or number of eyelashes. For the full list of all side effects reported with TRAVATAN, see the Package Leaflet.
TRAVATAN should not be used in people who are hypersensitive (allergic) to travoprost or any of the other substances. TRAVATAN contains benzalkonium chloride, which can make soft contact lenses opaque. Therefore, people who wear soft contact lenses should pay particular attention.
Why has TRAVATAN been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that TRAVATAN's benefits are greater than its risks in the treatment of increased intraocular pressure in patients with open-angle glaucoma or ocular hypertension and therefore recommended that it be authorized for placing on the market.
More information on TRAVATAN
On November 27, 2001, the European Commission issued a marketing authorization valid for TRAVATAN, which is valid throughout the European Union, to Alcon Laboratories (UK) Limited.
The marketing authorization was renewed on 27 November 2006.
The full EPAR for TRAVATAN can be found here.
Last update of this summary: 02-2007.
