Izba

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Different methodologies were used to collect adverse reactions during the development of travoprost. The most common adverse reaction observed in controlled clinical studies with travoprost 0.004% was ocular hyperemia. Ocular hyperemia was reported in 30 to 50% of patients by physician rating the severity of patient's post treatment ocular hyperemia compared to standardized reference photographs and/or patients who discontinued therapy due to ocular hyperemia.

In a 3 month clinical trial involving 442 patients exposed to IZBA (travoprost ophthalmic solution, 0.003%) and 422 control patients exposed to travoprost ophthalmic solution, 0.004%, the most common adverse drug reaction was ocular hyperemia. This was reported in 12% of patients treated with IZBA based on clinical observations and/or patient complaints. One patient (0.2%) discontinued treatment with IZBA due to ocular hyperemia. Rates observed in the control patients were comparable.

Ocular adverse reactions reported in clinical studies with travoprost ophthalmic solutions including IZBA at an incidence of 5% to 10% included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing.

Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections.

In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.

In the U.S.

• Izba
• Travatan
• Travatan Z

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Prostaglandin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because of travoprost's side effects, use in children younger than 16 years of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of travoprost eye drops in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye infection (bacterial keratitis) or
• Eye lens problems or
• Macular edema (swelling in the back part of the eye) or
• Uveitis (eye inflammation)—Use with caution. May make these conditions worse.

Your eye doctor will want to examine your eyes at regular visits to make sure that this medicine is working properly and is not causing unwanted effects.

This medicine may cause the iris (colored part), eyelid, or eyelashes of your treated eye to turn brown. Your eyelashes may also become longer, thicker, and darker. Some of these changes may be permanent even if you stop using travoprost. Check with your doctor if you have any questions about this.

Check with your doctor right away if you have an eye injury, eye infection, or plan to have eye surgery.

Ophthalmic solution containing travoprost 0.03 mg/mL.

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.  

Different methodologies were used to collect adverse reactions during the development of travoprost. The most common adverse reaction observed in controlled clinical studies with travoprost 0.004% was ocular hyperemia. Ocular hyperemia was reported in 30 to 50% of patients by physician rating the severity of patient’s post treatment ocular hyperemia compared to standardized reference photographs and/or patients who discontinued therapy due to ocular hyperemia. 

In a 3 month clinical trial involving 442 patients exposed to Izba (travoprost ophthalmic solution, 0.003%) and 422 control patients exposed to travoprost ophthalmic solution, 0.004%, the most common adverse drug reaction was ocular hyperemia. This was reported in 12% of patients treated with Izba based on clinical observations and/or patient complaints. One patient (0.2%) discontinued treatment with Izba due to ocular hyperemia. Rates observed in the control patients were comparable.

Ocular adverse reactions reported in clinical studies with travoprost ophthalmic solutions including Izba at an incidence of 5% to 10% included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing.

Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections.

In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.

A single clinical trial of 3 months duration was conducted to compare the IOP-lowering effect of Izba (travoprost ophthalmic solution) 0.003% to TRAVATAN* (travoprost ophthalmic solution) 0.004% , with both dosed once daily in the evening in adult patients with open angle glaucoma or ocular hypertension. Patient age ranged from 21 to 92 years, with a mean age of 65 years. A total of 864 patients (Izba, 442 patients; TRAVATAN, 422 patients) were enrolled, with 840 (97%) completing through Month 3. 

Analysis was based on the intent-to-treat (ITT) population defined as all patients who received study drug and completed at least one scheduled on-therapy study visit. 

The least squares mean IOP (mmHg), the difference in mean IOP (Izba minus TRAVATAN), and the 95% CI for the treatment difference in mean IOP at visit and time point are presented in Table 1. The differences in the mean IOP at all visits and time points were within ±1 mmHg, demonstrating equivalence of Izba to TRAVATAN in lowering intraocular pressure.  

Table 2 presents the mean IOP change from baseline at Week 2, Week 6, and at Month 3. Izba demonstrated comparable IOP reductions at all on-therapy visits and time points; the mean IOP reduction from baseline in the Izba group ranged from 7.1 to 8.2 mmHg and in the TRAVATAN group ranged from 7.1 to 8.4 mmHg. In both treatment groups, the greatest mean IOP reduction was observed at the 8 AM assessment time point. 

SE = Standard Error; CI = Confidence Interval † Estimates for Week 2, Week 6, and Month 3 are based on least squares means derived from a statistical model that accounts for correlated IOP measurements within patient where site and 8 AM baseline IOP stratum are in the model; estimates for Baseline visit at each time point are based on a two sample indepen dent t-test procedure.  **One subject had missing data at 8 AM at Week 6; one subject had missing data at 4 PM at Month 3.

†One subject had missing data at 8 AM at Week 6; one subject had missing data at 4 PM at Month 3.

Applies to travoprost ophthalmic: ophthalmic solution

Ocular

Very common (10% or more): Ocular hyperemia (up to 50%)
Common (1% to 10%): Decreased visual acuity, eye discomfort, foreign body sensation, eye pain, eyelid pruritus, abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, tearing
Uncommon (0.1% to 1%): Corneal erosion, uveitis, iritis, anterior chamber inflammation, punctate keratitis, eye discharge, erythema of eyelid, periorbital edema, ectropion cataract, eyelid margin crusting, growth of eyelashes, eyelash discoloration, asthenopia
Rare (less than 0.1%): Iridocyclitis, eye inflammation, photopsia, eyelid eczema, conjunctival edema, halo vision, conjunctival follicles, eye hypoesthesia, meibomianitis, anterior chamber pigmentation, mydriasis, eyelash thickening, macular edema, sunken eyes
Postmarketing reports: Periorbital/lid changes (including deepening of the eyelid sulcus)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Skin hyperpigmentation (periocular), skin discoloration, abnormal hair texture, hypertrichosis
Rare (less than 0.1%): Allergic dermatitis, contact dermatitis, erythema, rash, hair color changes, madarosis
Frequency not reported: Pruritus, abnormal hair growth[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris, bradycardia, chest pain, hypertension, hypotension
Uncommon (0.1% to 1%): Palpitations
Rare (less than 0.1%): Irregular heart rate, decreased heart rate, decreased diastolic blood pressure, increased systolic blood pressure
Frequency not reported: Tachycardia[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, gastrointestinal disorder
Rare (less than 0.1%): Reactivated peptic ulcer, constipation, dry mouth
Frequency not reported: Diarrhea, abdominal pain, nausea[Ref]

Genitourinary

Common (1% to 10%): Prostate disorder, urinary incontinence, urinary tract infections
Frequency not reported: Dysuria, increased prostatic specific antigen[Ref]

Musculoskeletal

Common (1% to 10%): Arthritis, back pain
Uncommon (0.1% to 1%): Shoulder pain
Rare (less than 0.1%): Musculoskeletal pain
Frequency not reported: Arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Rare (less than 0.1%): Dysgeusia
Frequency not reported: Vertigo, tinnitus[Ref]

Respiratory

Common (1% to 10%): Bronchitis, cold/flu syndrome, sinusitis
Uncommon (0.1% to 1%): Dyspnea, asthma, nasal congestion, throat irritation
Rare (less than 0.1%): Respiratory disorder, oropharyngeal pain, cough, dysphonia
Frequency not reported: Aggravated asthma[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia[Ref]

Other

Common (1% to 10%): Pain
Uncommon (0.1% to 1%): Asthenia, malaise[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression[Ref]

Immunologic

Rare (less than 0.1%): Herpes simplex, herpetic keratitis[Ref]

General

The most commonly reported side effect was ocular hyperemia.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, seasonal allergy[Ref]

Some side effects of Izba may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Animal studies have shown teratogenic results. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

AU: Use is contraindicated. UK, US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle.

Summary of Use during Lactation

No information is available on the use of travoprost during breastfeeding. Because of its short half-life it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References