Eyeworld

EW FEATURE 40 by Ellen Stodola FDA/AGS meeting facilitates discussion about future of MIGS devices T he FDA/AGS Workshop on Supporting Innovation for Safe and Effective Mini- mally Invasive Glaucoma Surgery was held in Wash- ington, D.C. on February 26, just be- fore the annual American Glaucoma Society (AGS) meeting. Participants from both the AGS and the U.S. Food and Drug Administration (FDA) discussed the current state of minimally invasive glaucoma surgery (MIGS) and the future of these devices. "We are always interested in eliciting input from the major stake- holder of medical devices—the healthcare providers," said Malvina B. Eydelman, MD, director of the Division of Ophthalmic, Neurologi- cal and Ear, Nose and Throat Devices, Office of Device Evaluation, Center of Devices and Radiological Health (CDRH), FDA. "By asking glaucoma experts to provide their insight into the clini- cal trial challenges associated with MIGS devices, we hope to better understand important factors in selecting the appropriate patients and endpoints for evaluating them," she said. Among the many physicians who took part, Malik Kahook, MD, Slater Family Endowed Chair in Ophthalmology and professor of ophthalmology, University of Col- orado School of Medicine, Aurora, Colo., and Steven Vold, MD, Vold Vision, Fayetteville, Ark., attended and discussed the meeting after- ward. Dr. Kahook said he believes this type of meeting between the FDA and the medical community can help the approval process. "Further clarity can be achieved when you get all parties in a room to discuss the known unknowns and the unknown unknowns," he said. "We are all in this together and we all want the same thing—for our patients to have more options and better treatments." Currently, the iStent (Glaukos, Laguna Hills, Calif.), Trabectome (NeoMedix, Tustin, Calif.), and endoscopic cyclophotocoagulation (ECP, Endo Optiks, Little Silver, N.J.) are approved in the U.S. Devices in the approval pipeline include the Hydrus (Ivantis, Irvine, Calif.), Cypass (Transcend Medical, Menlo Park, Calif.), and XEN Gel Stent (AqueSys, Irvine, Calif.). Dr. Vold said that many doctors at the meeting shared the opinion that one year of good safety and efficacy data could be sufficient to obtain FDA approval. "I think it's important that we look at the new procedures that are available and realize that these are just the first step," Dr. Vold said. "With each evolving surgery, the efficacy will likely improve." Reason for the meeting The MIGS workshop was co-spon- sored by the FDA and AGS. "My division worked with AGS members to develop the agenda as well as the discussion topics," Dr. Eydelman said. "CDRH is committed to facili- tating innovation in the ophthalmic arena, and the clinical trial topics discussed at this workshop will aid in this goal." The meeting was held to explore how FDA approval of MIGS devices can be further clarified and stream- lined, Dr. Kahook said. The FDA does not currently have firm guidance documents to help with pivotal trials for these devices. "Each company must 'recreate the wheel' when they meet with the FDA," Dr. Kahook said. "The FDA is burdened by the added work that comes with so many new MIGS de- vices seeking regulatory approval." He said that a unified guidance that addresses many of the vague aspects of pivotal trials in the MIGS space could help the FDA. "One of the key purposes of this important meeting was to facilitate good communication between the Glaucoma May 2014 AT A GLANCE • Patient selection is an important factor in studies for MIGS devices, and guidelines for which types of patients should be enrolled could be helpful. • Safety and efficacy are important elements in the study of the success of MIGS devices. • Suprachoroidal outflow could be a promising MIGS target because of preliminary safety results, the anatomical approach, and its potential for the best IOP-lowering efficacy. I n this Monthly Pulse survey on the topic of glaucoma, participants were asked: If you had to base your diagnosis and treatment of glaucoma on just one test, which would it be? The majority answered "Visual examination of the optic nerve." We asked participants about the following scenario: Your patient is a 40-year-old woman with angle closure glaucoma. She has had PIs in both eyes and one eye is doing well. The other eye is on three topical meds (maximal treatment for her) but still has pressures in the 20s with occasional pressures of 30+. Most of the angle is closed. Her visual field is normal, but the optic nerve in that eye definitely has more cupping than in the other eye, which has normal pressures. Her vision is 20/20. The Monthly Pulse Keeping a Pulse on Ophthalmology majority would refer to a glaucoma specialist; this response was followed closely by "Trabeculectomy (perhaps with an EX-PRESS Glaucoma Filtration Device)" and "Cataract surgery." When we asked about personal experience with intraocular pressures following cataract surgery in patients with angle closure glaucoma, more than half of the participants in this survey responded, "The IOP decreases most of the time but rarely enough that medications can be discontinued." Finally, we asked what participants predict will be the leading treatment for glaucoma in 5 years. More than half said, "Conventional eye drops will still dominate." The CyPass Micro-Stent and iStent Supra are two ab interno supraciliary devices in U.S. clinical studies. Dr. Vold's presentation discussed the way that supraciliary stenting could create a conduit to the suprachoroidal space. Source: Steven Vold, MD

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