EyeWorld Asia-Pacific September 2014 Issue

September 2014 28 EWAP GLAUCOMA Current ab interno supraciliary devices in US clinical studies CyPass Micro-­‐Stent iStent Supra 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., U.S.), Trabectome (NeoMedix, Tustin, Calif., U.S.), and endoscopic cyclophotocoagulation (ECP, Endo Optiks, Little Silver, NJ, U.S.) are approved in the U.S. Devices in the approval pipeline include the Hydrus (Ivantis, Irvine, Calif., U.S.), Cypass (Transcend Medical, Menlo Park, Calif., U.S.), and XEN Gel Stent (AqueSys, Irvine, Calif., U.S.). 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.” FDA/AGS meeting facilitates discussion about future of MIGS devices Discussions and topics sought to aid “innovation in the ophthalmic arena” T he FDA/AGS Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery was held in Washington, D.C. on February 26, just before 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 stakeholder of medical devices— the healthcare providers,” said Malvina B. Eydelman, MD , director of the Division of 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. by Ellen Stodola EyeWorld Staff Writer Ophthalmic, Neurological 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 clinical 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 Colorado School of Medicine, Aurora, Colo., U.S., and Steven Vold, MD , Vold Vision, Fayetteville, Ark., U.S., attended and discussed the meeting afterward. 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 Cu rent ab interno suprac liary devices in S clinical studies CyPass Micro-­‐Stent iStent Supra