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November 2012 Regulatory, other issues remain in CXL treatment by Erin L. Boyle EyeWorld Senior Staff Writer the treatment here, according to R. Doyle Stulting, M.D., who spoke during a recent ASCRS webinar. The regulatory process has no end in sight, he said. "It's anyone's guess when the C [U.S. Food and Drug Administration] is going to act, but a trial that [starts] today would probably have a year of data collection and patient recruit- ment for a 6-month follow-up, then maybe a 6-month review time, and then another 6 months to approval, so we're probably 2 years away, at a minimum, from today," said Dr. Stulting, Woolfson Eye Institute, Atlanta. He spoke during the hour-long crosslinking webcast, sponsored by the ASCRS Cornea and Refractive Surgery Clinical Committees. Dr. Stulting and Terry Kim, M.D., professor of ophthalmology, Duke University School of Medicine, Durham, N.C., hosted the interac- tive web seminar, which featured A. John Kanellopoulos, M.D., associ- ate clinical professor of ophthalmol- ogy, New York University, New York, and director of Laser Vision, GR Institute, Athens, Greece, and William B. Trattler, M.D., director of Cornea, Center for Excellence in Eye Care, Miami. Use in U.S. Dr. Stulting, who has been perform- ing CXL for 4 ½ years, said that American physicians are placing themselves at legal risk if they are performing the treatment off-label. However, he said some physicians are not willing to advise their pa- tients to go to Canada or Europe for CXL, where it is approved for use. "The way those folks feel is, this is the right thing to do for their pa- tients, and they shouldn't ask people to leave the United States to get a treatment that is accepted interna- tionally and has been reported many times in the print peer-reviewed lit- erature and that has the capability of preventing about 20% of the corneal transplants that we perform in the [U.S.] if it were used on all potential candidates," he said. Dr. Trattler has been performing CXL in a clinical trial for 2 ½ years. orneal collagen crosslink- ing (CXL) is not yet approved for use in the U.S., which could create issues for physicians using Dr. Kanellopoulos has treated 1,500 eyes with CXL in the last 10 years. They discussed their approaches, as well as the safety and efficacy of the procedure in their experience. Epi-on, epi-off Dr. Trattler performs epithelium-on CXL, while Dr. Kanellopoulos per- forms epithelium-off, a difference that has generated controversy. Dr. Trattler said that he has experienced great safety and efficacy using the epi-on procedure. "The advantages are pretty obvi- ous. Without removing epithelium, if you can perform crosslinking, you can help avoid the risk of infection, reduce the risk of haze or delays in epithelium healing," Dr. Trattler said. "So the question comes down to whether you can get enough ri- boflavin into the cornea," he said. "And the key thing that people sometimes forget is that there is no time limit to how long it may take to get riboflavin into the cornea. It takes us about an hour to an hour and 10 minutes to get riboflavin into the cornea at sufficient levels, much longer than the epi-off or some other techniques." Dr. Kanellopoulos said that a potential issue with epi-on CXL is if the riboflavin-soaked epithelium blocks the UV light that must get through the cornea to meet the deep-soaked riboflavin for the crosslinking effect. "Several years ago, we intro- duced the concept of creating a femtosecond laser pocket within the cornea and being able to fill riboflavin directly in mid-stroma and anterior stroma, and then place no riboflavin on the surface of the eye and crosslink through the intact epithelium," Dr. Kanellopoulos said. "That technique appeared to have significant efficacy, similar to the epi-off technique, and obviously has some of the advantages of epi-on as well. So that's a different approach to the same issue." EW Editors' note: Alcon (Fort Worth, Texas) provided a grant for production of the webcast. Dr. Kanellopoulos has financial interests with Alcon, Bausch + Lomb (Rochester, N.Y.), Ocular Therapeutix (Bedford, Mass.), Revision Optics (Lake Forest, Calif.), Avedro (Waltham, Mass.), and Seros Jump to the site using your smartphone and this QR code, or go to EWrePlay.org Medical (Los Altos, Calif.). Dr. Kim has financial interests with Alcon, Allergan (Irvine, Calif.), Bausch + Lomb, Inspire Pharmaceuticals (Raleigh, N.C.), and ISTA Pharmaceuticals (Irvine, Calif.). Dr. Stulting has no financial interests related to this article. Dr. Trattler has financial interests with Abbott Medical Optics (Santa Ana, Calif.), Allergan, Bausch + Lomb, and ISTA. Contact information Kanellopoulos: ajk@brilliantvision.com Kim: terry.kim@duke.edu Stulting: dstulting@woolfsoneye.com Trattler: wtrattler@gmail.com EW NEWS & OPINION 3 Missed an EyeWorld event at the 2012 ASCRS•ASOA Symposium & Congress? Find out what happened here! EyeWorld rePlay Special Edition offers video wrap-ups and pearls from EyeWorld events at the 2012 ASCRS•ASOA Symposium & Congress in Chicago. www.EWrePlay.org