Eyeworld

EW FEATURE 54 the mechanism of action embraced by the iStent Supra. "CyPass capitalizes on the fact that uveoscleral outflow has a big absorptive capacity. The supracho- roidal space is very large and it provides an absorptive sink for aqueous," said Sean Ianchulev, MD, chief medical officer and head of medical affairs and business devel- opment, Transcend Medical, and associate clinical professor, Universi- ty of California, San Francisco. He explained, "There are many approaches to lowering IOP phar- macologically, but prostaglandin analogues, which work by enhanc- ing the same uveoscleral outflow, seem to be most effective. They are much more efficacious in lower- ing IOP than all other targets and mechanisms of action. I think that superciliary stenting with the CyPass really targets that mechanism of su- prachoroidal outflow in redirecting and augmenting aqueous flow to the suprachoroidal space—thus lowering IOP. It is a unique approach mecha- nistically." The CyPass is a fenestrated micro-stent that is 6.35 mm long and 510 µm in diameter, made of a polyimide material. The ab interno insertion is straightforward and simpler than more conventional stents, like the iStent, that stent the trabecular flow, he said. In Europe, the CyPass was evalu- ated in different studies for safety and efficacy in mild to moderate OAG patients and in patients failing topical therapy, as a standalone treatment. In both studies, the patients experienced a reduction of IOP by more than one-third and a 50% decrease in the number of medications, after at least 1 year of follow-up. "This is the second MIGS device on the threshold of FDA approval, following the iStent. The CyPass has been approved and CE marked in Europe now for more than 6 years. The outcomes of the COMPASS clinical trial will be reported at the ASCRS and AAO meetings in 2016," Dr. Ianchulev said. The COMPASS trial is a pro- spective, multicenter, randomized, controlled trial conducted at 27 sites in the U.S. that randomized more than 500 POAG patients undergoing cataract surgery to undergo cataract surgery with or without the implan- tation of the CyPass. 4 The study has been completed and is currently under premarket approval review. FDA approval is expected later this year. "Ultimately, physicians will look at the data on efficacy and safety and make their own estimate on how this fits in the war chest against glaucoma. In the context of the la- bel, the device is likely to be labeled for patients having cataract surgery, and a patient only has cataract sur- gery once, so doctors will choose the MIGS device that has the best risk benefits. Like with pharmacological treatment for glaucoma, we have the benefit of different options, and it is up to the physician to use his or her judgment," Dr. Ianchulev said. EW References 1. Grover D. Describing the development of a minimally invasive collagen stent for treating glaucoma: First 975 eyes treated with the XEN implant. Presented at the 2016 American Glaucoma Society meeting, Fort Lauderdale, Florida. 2. Junemann J. Twelve-month outcomes fol- lowing ab interno implantation of a supracho- roidal stent and postoperative administration of travoprost to treat open angle glaucoma. Presented at the 2013 European Society of Cataract & Refractive Surgeons meeting, Amsterdam. 3. Pfeiffer N, et al. A randomized trial of a Schlemm's canal microstent with phacoemul- sification for reducing intraocular pressure in open-angle glaucoma. Ophthalmology. 2015;122:1283–1293. 4. COMPASS: Study of an implantable device for lowering intraocular pressure in glaucoma patients undergoing cataract surgery. Identifi- er: NCT01085357 Editors' note: Dr. Ansari has financial interests with Ivantis. Dr. Grover has financial interests with Allergan. Dr. Ianchulev has financial interests with Transcend Medical. Dr. Lewis has financial interests with Alcon (Fort Worth, Texas), Allergan, Glaukos, and Ivantis. Contact information Ansari: hansari@eyeboston.com Grover: dgrover@glaucomaassociates.com Ianchulev: sianchulev@transcendmedical.com Lewis: rlewiseyemd@yahoo.com A NEW ERA IN STERILE TISSUE ALLOGRAFTS EASY-PEEL PACKAGING Patented easy-peel packaging allows for quick introduction of sterile tissues to the surgical field, saving valuable OR time. 99.9% CLARITY Unlike traditional patches, Halo tissue grafts are clear and will remain clear, resulting in simplified post-op assessment and improved patient cosmesis. STABLE STORAGE Halo tissues can remain at room temperature and never need reconstitution, so you'll always be ready for emergencies as well as scheduled procedures. 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