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Home » Directories » FDA Approved Drugs » Travatan (travoprost ophthalmic solution)

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Travatan (travoprost ophthalmic solution)

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    General Information

    Travatan has been approved by the FDA for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It is indicated for patients who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications.

    Travoprost, the active ingredient in Travatan, is a synthetic prostaglandin analogue. It targets the prostanoid receptor and is believed to reduce intraocular pressure by increasing the drainage of fluid (aqueous humor) from the eye.

    There are approximately two to three million individuals in the United States with glaucoma, a condition often associated with elevated intraocular pressure leading to optic nerve damage. Glaucoma is a leading cause of blindness, accounting for approximately 12% of all new cases in the United States each year. While glaucoma significantly affects all races and ages, it appears to particularly target individuals of African descent, appearing at an earlier age and progressing at a more rapid rate. Travatan, unlike other glaucoma treatments, has demonstrated greater effectiveness in African-American patients.

    Clinical Results

    Trial results demonstrated that subjects with open-angle glaucoma or ocular hypertension who were treated with Travatan Ophthalmic Solution 0.004% experienced 7-8 mm Hg reductions in intraocular pressure. Subjects had a baseline pressure of 25-27 mm Hg and were dosed once-daily in the evening. Subgroup analyses of these trials showed that mean IOP reduction in African-American subjects was up to 1.8 mm Hg greater than in non-African-American subjects. At this time, it is not known whether this difference is due to race or to heavily pigmented irides.

    A multicenter, randomized, controlled trial evaluated the efficacy of Travatan dosed adjunctively to Timoptic. Results showed that subjects with a mean baseline intraocular pressure of 24-26 mm Hg on Timoptic 0.5% BID who were treated with Travatan 0.004% dosed QD adjunctively to Timoptic 0.5% BID demonstrated 6-7 mm Hg reductions in intraocular pressure.

    Side Effects

    The use of Travatan has been associated with possibly permanent changes in pigmented tissues, including increased pigmentation of the iris and periorbital tissue (eyelid) and increased pigmentation and growth of eyelashes.

    The most common eye-related adverse event reported in clinical trials was ocular hyperemia, which was reported in 35 to 50% of subjects. Other events included (but are not limited to) the following:

    • Decreased visual acuity
    • Eye discomfort
    • Foreign body sensation
    • Pain
    • Pruritus

    Mechanism of Action

    Travoprost free acid is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time. (from Travatan Label)

    Additional Information

    Travatan should not be administered while wearing contact lenses - the drug contains benzalkonium chloride, which may be absorbed by the lens. Additionally, contact between the tip of the container and the eye or surrounding area should be avoided when administering Travatan. This contact could cause the tip to become contaminated and result in ocular infection.

    If you are interested in learning more about glaucoma, please visit the National Institutes of Health, National Eye Institute.

    Additional information on Travatan can be obtained by visiting Alcon.

    Approval Date: 2001-03-01
    Company Name: Alcon
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