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EW NEWS & OPINION 3 IOLs in their first, highly con- tentious days. During his talk on February 2011 by Faith A. Hayden EyeWorld Staff Writer Winter Update wrap-up TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% Initial U.S. Approval: 2001 Brief Summary of Prescribing Information 1 INDICATIONS AND USAGE TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z ® (travoprost ophthalmic solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 2 hours after the Ä rst administration with maximum effect reached after 12 hours. TRAVATAN Z ® may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least Ä ve (5) minutes apart. 3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing travoprost 0.04 mg/mL. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Pigmentation Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. 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. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be exam- ined regularly. 5.2 Eyelash Changes TRAVATAN Z ® 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. 5.3 Intraocular Inë ammation TRAVATAN Z ® should be used with caution in patients with active intraocular iné am- mation (e.g., uveitis) because the iné ammation may be exacerbated. 5.4 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z ® 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. 5.5 Angle-closure, Inë ammatory or Neovascular Glaucoma TRAVATAN Z ® has not been evaluated for the treatment of angle-closure, iné amma- tory or neovascular glaucoma. 5.6 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 inad- vertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 5.7 Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAVATAN Z ® and may be reinserted 15 minutes following its administration. 6 ADVERSE REACTIONS 6.1 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 com- pared to rates in the clinical studies of another drug and may not reé ect the rates observed in practice. The most common adverse reaction observed in controlled clinical studies with TRAVATAN ® (travoprost ophthalmic solution) 0.004% and TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% 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 studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies with TRAVATAN ® or TRAVATAN Z ® included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular iné ammation, 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/é u syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C Teratogenic effects: Travoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats at IV doses up to 3 mcg/ kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/ day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD). In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day 21 at doses of ≥ 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity. There are no adequate and well-controlled studies of TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% administration in pregnant women. Because animal reproductive studies are not always predictive of human response, TRAVATAN Z ® should be administered during pregnancy only if the potential beneÄ t justiÄ es the potential risk to the fetus. 8.3 Nursing Mothers A study in lactating rats demonstrated that radiolabeled travoprost and/or its me- tabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, cau- tion should be exercised when TRAVATAN Z ® is administered to a nursing woman. 8.4 Pediatric Use 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. 8.5 Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. 8.6 Hepatic and Renal Impairment Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients. 16 HOW SUPPLIED/STORAGE AND HANDLING TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% is a sterile, isotonic, buff- ered, preserved, aqueous solution of travoprost (0.04 mg/mL) supplied in Alcon's oval DROP-TAINER ® package system. TRAVATAN Z ® is supplied as a 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL natural polypropylene dispenser bottle with a natural polypropylene dropper tip and a turquoise polypropylene or high density polyethylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 2.5 mL Ä ll NDC 0065-0260-25 5 mL Ä ll NDC 0065-0260-05 Storage: Store at 2° - 25°C (36° - 77°F). Rx Only U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253 ® ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA © 2006, 2010 Alcon, Inc. TRV10500PI AAA992-0910 continued on page 12 T he 2011 Winter Update, held in sunny Palm Beach, Fla., by ASCRS and the American Society of Oph- thalmic Administrators (ASOA), gave attendees a much needed break from the frigid January temperatures overwhelming most of the U.S., as well as lively discussions on thought-provoking topics. The meeting was held at the Ritz Carlton, Palm Beach, January 27–31. When attendees weren't in sessions, they spent their time on the hotel's acres of tropical gardens, in one of the two outdoor pools, or on its exclusive beach. This year's meeting was chaired by Edward J. Holland, M.D., profes- sor of ophthalmology, University of Cincinnati, and director, Cornea Service, Cincinnati Eye Institute, and Stephen S. Lane, M.D., clinical professor of ophthalmology, Univer- sity of Minnesota, Minneapolis. The doctors kicked off the event with a welcoming on Friday morning. The 2011 Winter Update guest of honor was Normal S. Jaffe, M.D., clinical professor of ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, Univer- sity of Miami. Dr. Jaffe was a founder of the American Intra- Ocular Implant Society, which later became ASCRS. He was the first American to deliver the Binkhorst Lecture and was one of the most prominent advocates of the use of

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