Eyeworld

47 EW FEATURE May 2016 • Microinvasive glaucoma surgery (MIGS) Sustained 30 % IOP lowering at 12, 14, and 20 hours post-dose in a 3-month study 1,2 * CHOOSE TRAVATAN Z ® Solution: A POWERFUL START 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 1 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 1 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. 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 studies with 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 studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. Use in Specifi c 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 about TRAVATAN Z ® Solution, please see the brief summary of Prescribing Information on the adjacent page. Help patients start strong and stay on track with TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent available TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent available * Study Design: Double-masked, randomized, parallel-group, multicenter non-inferiority comparison of the effi cacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) to TRAVATAN Z ® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. 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) 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. Statistical equivalent reductions in IOP (95% confi dence interval about the treatment differences were entirely within ±1.5 mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment. References: 1. Data on fi le, 2013. 2. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and effi cacy. J Glaucoma. 2007;16(1):98-103. © 2015 Novartis 10/15 US-TRZ-15-E-0278 Not actual patient disadvantage of the microcatheter technique is that it cuts the trabecu- lar meshwork instead of removing it, leaving the potential for scarring, Dr. Sit said. Arsham Sheybani, MD, assis- tant professor of ophthalmology and visual sciences, Washington Univer- sity School of Medicine, St. Louis, said he would prefer a stent rather than ablation or stripping the tra- becular meshwork in patients who have met their goal IOP with topical medication because he considers it "less traumatic and [it] mimics phys- iology more closely." However, patients who have not reached their goal, he said, "are a different story." "One iStent will not be enough. In these cases, I prefer an ab interno trabeculotomy," Dr. Sheybani said, referencing Trab360 as his preferred choice over Trabectome because it provides the opportunity to treat a larger portion of the angle. "I do prefer this for complex anterior seg- ment cases as well, as iStent is not approved in these cases." He added that he would shy away from performing a full trabecu- lotomy in patients who are on blood thinning medication or have condi- tions that hamper blood clotting. Considering the complications Dr. Sheybani said that his preferred implantless procedure—a trabecu- lotomy with Trab360 or even with Trabectome—can result in hyphema. In a case of significant hyphema, he recommended stopping medication perioperatively, securing the wounds with a sealant or suture, and manag- ing the patient's anticoagulation. He also said steroid response can be a complication associated with these procedures. "I try to wean patients off ste- roids quickly, if possible," he said. "These devices produce such little inflammation that this is usually possible." Although not a medical compli- cation but certainly a complicating factor with some of these options is the cost. Many of the instruments used in the aforementioned MIGS are single use and others require the physician to purchase an expensive machine to conduct the procedure. Looking ahead, Dr. Sit said there are still many unknowns with MIGS procedures. "The data is lacking for sure, but I think that with angle proce- dures, there's a lot to suggest that the short-term results are better if we can bypass more of the trabecular meshwork. That can mean putting in more than 1 stent or removing larger areas of the trabecular mesh- work," he said. Dr. Sit also offered a word of caution about the removal of the trabecular meshwork versus putting in a stent, leaving the meshwork intact. "We don't have the treatment yet to directly target the underlying pathologies of the trabecular mesh- work that occur in glaucoma, but if we get to that point—and we may be getting to that point in the near future with new medications—then we may find it disadvantageous to remove the entire trabecular mesh- work," he said. EW Editors' note: Dr. Radcliffe has finan- cial interests with Glaukos, Iridex (Mountain View, California), Beaver Visitec (Waltham, Massachusetts), Transcend Medical (Menlo Park, California), New World Medical, and Allergan (Dublin). Drs. Tanaka and Sheybani have no financial interests related to their comments. Dr. Sit has financial interests with Aerie Phar- maceuticals (Bedminster, New Jersey), Allergan, and Glaukos. Contact information Radcliffe: drradcliffe@gmail.com Sheybani: Sheybaniar@vision.wustl.edu Sit: sit.arthur@mayo.edu Tanaka: ghtanakamd@gmail.com

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