EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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40 EW FEATURE February challenges/MIGS May 2013 Glaucoma 2011 AqueSys continued from page 39 The 6-mm AqueSys implant is positioned next to an Ahmed Glaucoma Valve (New World Medical) Anterior segment optical coherence tomography shows the soft AqueSys implant conforming to the tissue in a human eye the FDA. It has been approved for an IDE study that Mr. Bache said the company is currently enrolling for. "Right now, it's approved for sale outside of the United States," he said. Mr. Bache said AqueSys is very focused and has begun developing plans for commercialization outside of the U.S., as well as beginning the execution of well-controlled phase IV studies in the mild glaucoma population with and without cataract surgery. Dr. Lewis said the trial in the U.S. is progressing, although there is no data out yet to be examined. "It's a very challenging trial because the FDA mandated end-stage glaucoma patients for the 510(k) pathway," he said. These often included complicated patients who had failed previous conventional surgeries, he said, indicating he would be interested in executing FDA studies for patients with earlier stages of glaucoma as well. Studies outside the U.S. have shown patients with early glaucoma doing well with the implant, Dr. Lewis said. Concerns Microscopic pictures from a side view of implant versions with water column present at inner lumen Source (all): AqueSys Gary J.L. Foster, MD, Fort Collins, Colorado, explains to Joshua Young, MD, how he decides which patient needs combined or MIGS procedures and who needs just phaco alone. Go to ewreplay.org/ASCRS2013/saturday or scan the QR code above to view the video. Dr. Lewis said some of the concerns with the device are over scarring and whether the desired pressure reduction is being achieved. "When you take the right patient, the results have been good," he said. The safety is better than with a traditional surgery, like trabeculectomy or tube shunts, Dr. Samuelson said. But he suspects there is a bit more risk than there would be when placing a shunt in Schlemm's canal. However, he said there could be advantages with this risk. "There's also potentially more upside in that we could expect lower pressures with this procedure than we could expect to get with a stent. With the AqueSys procedure, we envision getting pressures in the low teens or even single digits." Other procedures and stents might see pressures no lower than the mid-teens, he said. "The beauty of this approach is that it's a much more efficient and less invasive way to accomplish what we accomplish in trabeculectomy," Dr. Samuelson said. It's an approach that's possible to combine with cataract surgery because surgeons can do it with the same incision. The AqueSys device does not currently use mitomycin at the time of surgery. There are mixed reviews on mitomycin being helpful at the time of surgery, but also having the possibility of causing complications. Dr. Lewis said it's hard to tell at this time the effect of not using mitomycin with the implant. "I think mitomycin is effective in glaucoma surgery, and I think it will probably find a role in this as well," he said, although that role remains to be determined. The use of mitomycin with the implant is a factor that Dr. Varma said needs to be considered. "I think that in early cases, there's not much of a need to use mitomycin," he said. However, he said this may be beneficial for patients who have already failed with surgeries in the past because it could help prevent scarring or increase the time that a patient experiences success with the implant. Dr. Varma said that the AqueSys implant is thought to be safe, with good results so far. He said the company has been working over the past few years to optimize the process of how it's inserted and placed into the eye. He believes it is important to focus on how to address operating approaches, like patients who may have had previous surgery. Goals for the device "The goal of the device is to be the first surgical procedure done when medications are not adequately controlling intraocular pressure," Mr. Bache said. If a patient is not compliant with medication or the medication is not working, he said AqueSys wants this to be surgeons' go-to option. It is focused on all stages of the disease with multiple implants focused on mild, moderate, and refractory glaucoma. EW Editors' note: Mr. Bache is the CEO of AqueSys. Dr. Varma has financial interests with AqueSys. Dr. Lewis has financial interests with AqueSys. Dr. Samuelson has financial interests with AqueSys. Contact information Bache: rbache@aquesys.com Lewis: rlewiseyemd@yahoo.com Samuelson: twsamuelson@mneye.com Varma: rvarma@usc.edu