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Monday, April 28, 2014 IMPORTANT SAFETY INFORMATION FOR CENTURION® VISION SYSTEM CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert® IOL Injector Handpiece does not perform as expected. INDICATION: The CENTURION® Vision System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal. The AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert® IOL Injector Handpiece is indicated for use with the AcrySof® lenses SN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses. WARNINGS: Appropriate use of CENTURION® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation. The consumables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards. AEs/COMPLICATIONS: Inadvertent actuation of Prime or Tune while a handpiece is in the eye can create a hazardous condition that may result in patient injury. During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip. ATTENTION: Refer to the Directions for Use and Operator's Manual for a complete listing of indications, warnings, cautions and notes. © 2014 Novartis 4/14 CNT13017JAD-A THE C ATARAC T REFRAC TIVE SUITE BY ALCON by Rich Daly Collagen crosslinking treatment expands C ollagen crosslinking provided good clinical outcomes among a small number of patients treated for myopia, as the poten- tial target patient population for the treatment continues to expand. John Kanellopoulos, MD, New York, authored a four-case series on collagen crosslinking's ability to achieve predictable refractive my- opic changes in virgin corneas. The report, published online this month in Clinical Ophthalmology, treated the cases with very high fluence collagen crosslinking applied in a myopic pattern. The study applied riboflavin solution to intact epithe- lium before engaging the collagen crosslinking device, which applied a total of 12 J/cm(2) transepithelially in a predetermined pattern. The treatment produced an average of 2.3 diopters of improve- ment within a week, with a slight regression at one month postop to 1.44 diopters, which it maintained at the six-month follow-up. Mean keratometry change was from 44.90 diopters to 43.46 diopters. The patients had no significant change in endothelial cell counts or corneal clarity, although there was some mild change in epithelial thickness distribution, with the treated area showing a slight but homogeneous reduction in mean thickness from 52 μm to 44 μm. This technique—utilizing crosslinking equipment from Avedro (Waltham, Mass.)—has the advantages of essentially no postop morbidity, immediate visual rehabil- itation, and the potential for tapering until the desired result is achieved, Dr. Kanellopoulos con- cluded. Its results could indicate the kind of precision that observers have questioned whether the treatment was able to provide. Leaders and supporters of Avedro described such results as an indication of the growing number of refractive conditions that the non- surgical technology has begun to show it can treat. "The window opens and the world changes and you start using this device in a very creative way," Dr. Kanellopoulos said at an EyeWorld Corporate Education event titled "Avedro Presents The Future of Cross-Linking." "You start looking at corneal irregularities while designing very focused treat- ment, which is the same way we've been using the properly guided excimer, but just with collagen crosslinking. " Such results, argued supporters, show that the widely accepted treat- ment of choice to stabilize corneal ectasia may also create a beneficial refractive effect in select applica- tions. However, the company's crosslinking technology hit a major seed bump last month when the U.S. Food and Drug Administration sent the company a complete response letter on its new drug ap- plication (NDA) for the riboflavin ophthalmic solution/KXL System to treat keratoconus and corneal ectasia after refractive surgery. "I don't think there is any question that crosslinking works for treating keratoconus; we know that it is safe, we believe the data is ro- bust enough, but now unfortunately we're required to go back through an appeals process," David Muller, PhD, president and CEO of Avedro, said about the regulatory concerns. "This is the beginning of the story for crosslinking." The company planned to build on the FDA's granting of orphan drug status to the riboflavin ophthalmic solution/KXL System for treatment of keratoconus and corneal ectasia after refractive sur- gery in 2011 and then granting of priority review status on the NDA in November 2013. But Avedro is pushing ahead with efforts to obtain regulatory approval for several other refractive uses for the technology. The company enrolled half of the study population to evaluate accelerated crosslinking, which aims to significantly reduce the duration of the procedure. Full enrollment is expected by September, Dr. Muller said. That comes in addition to a study planned for next year to examine the ability of crosslinking to treat high myopia, according to Peter Hersh, MD, Teaneck, N.J. Additionally, Dr. Hersh de- scribed the company's development of PiXL (photorefractive intrastro- mal crosslinking), which aims to use crosslinking and UV light to alter corneal collagen and thereby cause a refractive change, as "one of the more exciting things to happen with crosslinking using the Avedro platform." EW Editors' note: This event was sponsored by Avedro. John Kanellopoulos, MD, discusses recent research at an Avedro presentation on the increasing refractive roles for collagen crosslinking technology. Meeting Reporter

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