Travatan®
Travoprost 0.004% · ophthalmic solution
Antiglaucoma
Approved uses
Open-angle glaucoma or ocular hypertension
1 drop in the affected eye(s) QD in the evening
IOP begins to fall about 2 hours after the first dose, with maximum effect at 12 hours.
OFF-LABELNot in the FDA label for this product
Chronic angle-closure glaucoma after peripheral iridotomy
0.004% solution QD in the evening; trial duration 12 weeks
RCT · n=73 · unmasked
Randomized comparative trial in 73 patients with chronic angle-closure glaucoma and IOP above 19 mmHg after peripheral iridotomy, no prior glaucoma medication: 12 weeks of travoprost 0.004% QPM lowered mean IOP from 21.7 to 16.7 mmHg (P<0.001), with no significant difference versus latanoprost 0.005% (P=0.19). Single center, 12 week follow-up, no masking described; the formulation studied is not stated.
Pediatric glaucoma or ocular hypertension (below 16 years)
0.004% solution QD in both eyes (7 day pediatric pharmacokinetic study, polyquaternium-1 preserved formulation)
RCT · n=157 · not this product
Randomized, double-masked phase 3 trial in 157 patients aged 2 months to under 18 years (77 travoprost, 75 timolol): mean IOP change at 3 months was -5.4 mmHg versus -5.3 mmHg for timolol, difference -0.1 mmHg (95% CI -1.5 to 1.4), within the prespecified +3.0 mmHg noninferiority margin; ocular hyperemia and eyelash growth were the most common treatment-related events and no serious adverse events occurred. Both pediatric studies used the polyquaternium-1 preserved formulation, which is not the formulation supplied under this setid.
Contraindications
None.
Ophthalmic solution, 2.5 mL, 5 mL, each 0.04 mg/mL (0.004%)
Prostaglandin analog and selective FP prostanoid receptor agonist; the isopropyl ester prodrug is hydrolyzed by corneal esterases to a free acid believed to lower IOP by increasing uveoscleral outflow. Exact mechanism is not established.
Warnings & Precautions
- Iris and periocular pigmentation: Increased melanin content in melanocytes darkens the iris, eyelid skin, and lashes, and increases as long as dosing continues; iris change is likely permanent, periorbital and lash changes are reversible in some patients. Brown pigmentation spreads concentrically from the pupil and may take months to years to become noticeable; nevi and freckles are unaffected.
- Eyelash changes: Gradual increase in length, thickness, and number of lashes and vellus hair in the treated eye, usually reversible after discontinuation; unilateral use can leave a disparity between eyes in lash length, thickness, pigmentation, number, and growth direction.
- Intraocular inflammation: Caution with active intraocular inflammation such as uveitis, which may be exacerbated.
- Macular edema: Macular edema including cystoid macular edema reported; caution in aphakia, in pseudophakia with a torn posterior lens capsule, and with other known risk factors for macular edema.
- Unevaluated glaucoma subtypes: Not evaluated in angle-closure, inflammatory, or neovascular glaucoma.
- Bacterial keratitis: Inadvertently contaminated multi-dose containers have caused keratitis, in most cases in eyes with concurrent corneal disease or a disrupted epithelial surface.
- Contact lens wear: Remove lenses before instillation and reinsert 15 minutes afterward.
Common Side Effects
- Ocular hyperemia: 30% to 50%, the most common reaction; up to 3% discontinued for conjunctival hyperemia
- Ocular, 5% to 10%: decreased visual acuity, eye discomfort, foreign body sensation, pain, pruritus
- Ocular, 1% to 4%: abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, tearing
- Systemic, 1% to 5%: headache, bradycardia, hypertension, hypotension, angina pectoris, chest pain, bronchitis, sinusitis, cold or flu syndrome, arthritis, back pain, anxiety, depression, urinary tract infection
- Postmarketing: arrhythmia, tachycardia, insomnia, epistaxis, vomiting
- Prostaglandin class effect: periorbital and lid changes including deepening of the eyelid sulcus
Pregnancy: No adequate and well-controlled human studies. Subcutaneous dosing in pregnant rats and mice produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses, including adverse pregnancy outcomes in rats at 0.7 times the maximum recommended human ocular dose and teratogenicity (skeletal, external, and visceral malformations) in rats at 60 times. Use in pregnancy only if benefit justifies fetal risk.
Lactation: No human data; presence in human milk is unknown. Radiolabeled drug and metabolites were excreted in the milk of lactating rats after subcutaneous dosing.
Not recommended below 16 years because of pigmentation risk with long-term chronic use.