SEP 2013

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

Issue link: https://digital.eyeworld.org/i/176967

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Page 58 of 98

56 February 2011 Crosslinking September 2013 EW SECONDARY FEATURE Corneal collagen crosslinking still hot topic in U.S. by Ellen Stodola EyeWorld Staff Writer C orneal collagen crosslinking continues to be a hot topic in ophthalmology. Still seeking FDA approval in the U.S., the technology has been showing promising results in an Avedro (Waltham, Mass.) clinical trial currently in the process of seeking FDA approval and other investigational Institutional Review Board (IRB) trials, leading more and more physicians to get on board with it. In addition, combinations of crosslinking with other therapies have begun to emerge, and studies are being undertaken to determine results of crosslinking with Intacs (Addition Technology, Des Plaines, Ill.), LASIK, and other procedures. Roy S. Rubinfeld, MD, Washington Eye Physicians & Surgeons, Chevy Chase, Md.; Eric Donnenfeld, MD, clinical professor of ophthalmology, New York University Medical Center, New York; and Peter S. Hersh, MD, the Cornea & Laser Eye Institute, Teaneck, N.J., commented on the current state of crosslinking, trials and findings, and expectations for the future. Additionally, David Muller, PhD, president and CEO of Avedro, Waltham, Mass., spoke about the company's clinical trial, which is going through the FDA submission process, and other endeavors and advancements in crosslinking. Cobalt blue slit lamp appearance after 15 minutes of epithelial on loading with proprietary epi-on riboflavin solution from CXLO Current state of crosslinking "There are a plethora of studies that are ongoing right now, and it's very easy to get into these studies so that patients do have access to crosslinking," Dr. Donnenfeld said. Discussions on crosslinking bring up two main issues, he said, which are how the riboflavin is applied and the duration of the treatment. Advancements as studies progress have allowed for shorter treatment times and less invasive transepithelial procedures. "Crosslinking worldwide has been around for several years now, and I think that the consensus in the field is that it's something that is a very useful technique for the treat- ment of keratoconus and corneal ectasia with the goal of decreasing the progression of these disease processes, as well as in some cases actually improving vision," Dr. Hersh said. "In the U.S. there was an original multicenter clinical trial, and that currently is sponsored by Avedro," he said. This trial has been completed and is currently going through the FDA submission process. "This is occurring now," Dr. Hersh said. "The hope is that this would ultimately lead to FDA approval." The results in safety and efficacy were "quite encouraging," Dr. Hersh said. Though the actual clinical trial White light slit lamp photo of well loaded corneal stroma after 15 minutes of epithelium on loading using the same proprietary formulation in a 20-year-old patient with keratoconus. The yellow arrow shows that the epithelium is intact and is relatively free of riboflavin loading thus permitting UVA penetration for good crosslinking to occur using CXLO's proprietary corneal strengthening technology. Note AC flare with epithelium intact (epi-on CXL) Case results from epi-on crosslinking Source (all): Roy Rubinfeld, MD

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