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Efficacy
TRAVATAN Z® Solution demonstrated up to 30% sustained IOP lowering at 12, 14, and 20 hours postdose in a 3‑month study.1, 4
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Mechanism of Action
Travoprost free acid is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.2
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Safety Profile
TRAVATAN Z® Solution has an established safety profile.2 View common adverse reactions.
For patients with open-angle
glaucoma or ocular hypertension
TRAVATAN Z® SOLUTION DEMONSTRATED SIGNIFICANTLY LOWER MEAN IOP1
Patients were able to lower their mean IOP by up to 8.5 mm Hg from baseline1
Week 2
Week 6
Month 3
Study Design: Double-masked, randomized, parallel-group, multicenter noninferiority comparison of the efficacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) and TRAVATAN Z® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. Mean baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322), and 24.8 mm Hg (n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z® Solution. At the end of Month 3, the TRAVATAN Z® Solution group had mean IOPs (95% CI for the treatment differences) of 18.7 mm Hg (‑0.4, 0.5), 17.7 mm Hg (‑0.4, 0.6), and 17.4 mm Hg (‑0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistically equivalent reductions in IOP (95% CIs for the treatment differences were entirely within ± mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment.1
For patients with open-angle
glaucoma or ocular hypertension
TRAVATAN Z® SOLUTION DEMONSTRATED SIGNIFICANT AND SUSTAINED IOP LOWERING1
TRAVATAN Z® Solution achieved up to 30% sustained lowering at 12, 14, and 20 hours postdose in a 3‑month study1,4
Week 2
Week 6
Month 3
Study Time Points (Post-8 PM Dose)
Study Design: Double-masked, randomized, parallel-group, multicenter noninferiority comparison of the efficacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) and TRAVATAN Z® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. Mean baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322), and 24.8 mm Hg (n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z® Solution. At the end of Month 3, the TRAVATAN Z® Solution group had mean IOPs (95% CI for the treatment differences) of 18.7 mm Hg (‑0.4, 0.5), 17.7 mm Hg (‑0.4, 0.6), and 17.4 mm Hg (‑0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistically equivalent reductions in IOP (95% Cls for the treatment differences were entirely within ± mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment.1
Travoprost free acid, a prostaglandin, is a selective FP prostanoid receptor agonist
WHICH IS BELIEVED TO REDUCE INTRAOCULAR PRESSURE BY INCREASING UVEOSCLERAL
OUTFLOW2
The exact mechanism of action (MOA) is unknown at this time.2
Travoprost acid is a selective FP receptor analog, exhibiting a high affinity for the FP receptor and minimal affinity for other PG receptors.5
FP=Prostaglandin F; PG=Prostaglandin.
Are you concerned with patients wanting to discontinue therapy?
ONLY 3% OF PATIENTS DISCONTINUED USE DUE TO CONJUNCTIVAL HYPEREMIA2
TRAVATAN Z® Solution has an established safety profile.2
Reactions
Additional adverse reactions have been identified during post approval use of TRAVATAN® or TRAVATAN Z® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to TRAVATAN® or TRAVATAN Z®, or a combination of these factors, include: arrhythmia, vomiting, epistaxis, tachycardia, and insomnia. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.2
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INDICATIONS AND USAGE
TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Dosage and Administration
The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z® Solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP lowering effect.
TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Pigmentation – Travoprost ophthalmic solution has been reported to increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. The long-term effects of increased pigmentation are not known. While treatment with TRAVATAN Z® Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
Eyelash Changes – TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation – TRAVATAN Z® Solution should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Macular Edema – Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z® Solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
Angle-closure, Inflammatory or Neovascular Glaucoma – TRAVATAN Z® Solution has not been evaluated for the treatment of angle-closure, inflammatory, or neovascular glaucoma.
Bacterial Keratitis – There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Use with Contact Lenses – Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be reinserted 15 minutes following its administration.
Adverse Reactions
The most common adverse reaction observed in controlled clinical trials with TRAVATAN® (travoprost ophthalmic solution) 0.004% and TRAVATAN Z® Solution was ocular hyperemia, which was reported in 30% to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5% to 10% in these clinical trials included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus.
Additional adverse reactions have been identified during post approval use of TRAVATAN® or TRAVATAN Z® in clinical practice. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to TRAVATAN® or TRAVATAN Z®, or a combination of these factors, include: arrhythmia, vomiting, epistaxis, tachycardia, and insomnia. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.
Use in Specific Populations
Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
For additional information on TRAVATAN Z® Solution, click here for full Prescribing Information.
References: 1. Lewis RA, Katz GJ, Weiss MJ, et al; for Travoprost BAC-free Study Group. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma. 2007;16(1):98-103. 2. TRAVATAN Z® Solution Prescribing Information. Fort Worth, TX: Alcon Laboratories, Inc. 2017. 3. Fingertip Formulary, (estimate derived from information used under license from Fingertip Formulary, LLC, which expressly reserves all rights, including rights of copying, distribution, and republication) 2018. 4. Data on file. Novartis Alcon Laboratories, Inc; 2005. 5. Sharif NA, Kelly CR, Crider JY, et al. Ocular hypotensive FP prostaglandin (PG) analogs: PG receptor subtype binding affinities and selectivities, and agonist potencies at FP and other PG receptors in cultured cells. J Ocul Pharmacol Ther. 2003;19(6):501-515.
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