Eyeworld

MAY 2015

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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43 EW FEATURE May 2015 Secondary glaucoma challenges Lumenis (Yokneam, Israel). Dr. Moster has financial interests with Alcon, InnFocus (Miami, Fla.), SOLX (Waltham, Mass.), and Iridex. Dr. Al-Aswad has no financial interests related to her comments. Contact information Radcliffe: drradcliffe@gmail.com Moster: marlenemoster@gmail.com Al-Aswad: laa2003@cumc.columbia.edu Although MIGS procedures do not offer the same pressure-lowering effect as incisional surgeries, the physicians agreed that they are a better first-line surgical option. "Patients with exfoliation syndrome are going to be having cataract surgery in all likelihood, so it's advantageous to do the cataract surgery preferably with MIGS before performing a more heavy-duty glau- coma surgery such as a tube shunt or a trabeculectomy," Dr. Radcliffe said. The iStent is Food and Drug Administration-approved for open angle glaucoma. Because this device allows the aqueous outflow to bypass the juxtacanalicular trabec- ular meshwork—the site of greatest resistance to outflow—it conce - tually appears ideal for patients with pseudoexfoliation glaucoma. However, the company's premarket approval study was not powered with a sufficient number of these patients to demonstrate statistically significant efficacy in pseudoexfol - tion patients, Dr. Radcliffe said. "I think of the eye as real es- tate," Dr. Al-Aswad said. "The more I utilize from the real estate now, the less I have as the disease progresses. So if I can control something initial- ly with a minimally invasive proce- dure, which leaves the option for me in the future to do trabeculectomy or implants, then I do that." "My favorite procedure in pa- tients with moderate glaucoma is to combine the iStent with an ECP and cataract removal," Dr. Moster said. "This seems to have an excellent effect on both the initial pressure re- sponse and the longer-term pressure response by keeping postoperative medications to a minimum." What's next? New MIGS devices using the su- prachoroidal space and new trabe- culectomy-like procedures are in the pipeline, and these have tremendous potential to help pseudoexfoliation glaucoma patients, Dr. Moster said. "In the near future we will have a much broader choice of treatments to offer our patients to better control the intraocular pressure with or without combined cataract surgery," she said. It is important to remember that pseudoexfoliation glaucoma is an aggressive disease, Dr. Radcliffe said, and clinicians need to be prepared for that. "We can prepare ourselves by having all the appropriate baseline tests done—visual field, [optical coherence tomography], all of these different things—and if we are well prepared, we can best take care of these patients who are at a higher risk of worsening than other pa- tients," he said. It is important to remember that pseudoexfoliation is a systemic dis- ease, and there is a lot that we need to learn about it and its systemic association, Dr. Al-Aswad said. Gene therapy might be the way of the future. EW Editors' note: Dr. Radcliffe has fina - cial interests with Allergan (Irvine, Calif.), Alcon (Fort Worth, Texas), Iridex (Mountain View, Calif.), Glau- kos, Endo Optiks/Beaver Visitec, and TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent 3 © 2014 Novartis 9/14 TRV14066JAD 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. 3. Drugs@FDA. FDA Approved Drug Products: TRAVATAN Z. www.accessdata.fda.gov/ scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed July 31, 2014. 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 the Patient Support Program * 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. Sustained 30 % IOP lowering at 12, 14, and 20 hours post-dose in a 3-month study 1,2 * Choose BAK-free TRAVATAN Z ® Solution for sustained IOP lowering

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