JUN 2014

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

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by Matt Young EyeWorld Contributing Writer U.S., European regulatory approvals have decided differences The device—EyeOP1—is an ul- trasound technology that offers a non-invasive treatment for refrac- tory glaucoma. Now, 10 centers are using the device routinely in France. At the end of this year, the number will double in France. Devices also are in use in Spain, Italy, and northern European countries. iStar Medical, led by CEO and Director General Michel Alvarez, was founded in 2010 and received a CE mark in 2012 for its STARflo Glaucoma Implant, designed to operate as a bleb-free microporous drainage system to reduce IOP. "We recently announced a major funding round for our com- pany," Mr. Alvarez said. "This would allow us to begin a U.S. and larger European clinical study." In both cases, note how regula- tory approval in Europe is not the cornerstone of a large-scale market- ing campaign, but rather a step in the right direction. Companies con- tinue to investigate their devices even after obtaining a CE mark. Russ Trenary, president and CEO of InnFocus, mentioned how critical not only regulatory approval is, but also reimbursement code approval in the U.S., Europe, and elsewhere. The InnFocus Microshunt shunts aqueous fluid from the anterior chamber of the eye to a subconjunctival/sub-Tenon's space. The inertness of the polymer used is claimed to have less tissue reaction than conventional materials. How- ever, without a reimbursement code, technologies like the InnFocus Microshunt would not as easily prevail, Mr. Trenary said. Fortunately, the InnFocus Mi- croshunt already has an appropriate reimbursement code in the U.S. "We are undergoing the FDA clinical trial approval process, with the last phase trial occurring next year, and we already have a CE mark. In Europe, there are additional studies we will need to do in order to put ourselves in the best position to get appropri- ate reimbursement," he said. U.S. and European differences Dan Reinstein, MD, understands the regulatory environment both in the U.S. and Europe. In 2001, he left the U.S. and moved to Europe in order to work with Carl Zeiss Meditec (Jena, Germany). He then I n the United States, the FDA requires strict clinical evidence demonstrating safety and effi- cacy of a drug or medical de- vice prior to its marketing. In Europe, companies often get regula- tory approval first—largely based on safety and some other factors—and then demonstrate further product efficacy before market release. The European approach appears to be supporting innovation in glaucoma, with CE marks relatively easily obtained by EyeTechCare (Rillieux-la-Pape, France), iStar Medical (Isnes, Belgium), InnFocus (Miami, Fla.), and others. These companies are taking additional steps to ensure safety and efficacy—despite already having European regulatory approval— before widespread launch into the marketplace. Waiting to market "Our CE mark was obtained in 2011, but we didn't start immediately [to market our device]," said Fabrice Romano, CEO of EyeTechCare. "We needed time to find a good indica- tion for it. We started marketing the technology last year." founded London Vision Clinic in 2002, a private refractive surgery practice. "The CE mark and FDA ap- proval processes do the same thing in assessing the safety and efficacy of new devices; however, the documentation required by the investigator is much more efficient when applying for the CE mark," Dr. Reinstein said. "The review cycle is shorter, and there are almost always more rounds of questions with the FDA." However, the biggest difference between the two is the possibility for CE mark approval to be obtained through a "clinical evaluation." "If there are predicate equivalent devices already being used in the market with published safety and efficacy data, then you can obtain a CE mark based on the already pub- lished data, even for a higher risk type of device," Dr. Reinstein said. "The only requirement is that a post-market clinical follow-up study is performed after obtaining the CE mark, but this kind of study is much easier to get approval for and there- fore much less expensive for the company." "In addition, the approved range of parameters is usually much narrower with FDA approval," Dr. Reinstein said. "Doctors in the U.S. are therefore not given any room to make small improvements to optimize the applications. The Euro- pean approval method puts more 'onus and trust' on the companies who can decide in their clinical eval- uation whether the existing body of evidence is sufficient to claim safety and efficacy for the new device, and on doctors to clinically decide how to use devices on their patients without making them feel bad about changing parameters based on clinical judgment to settings that were not specifically used in the clinical approval trials. I have heard the FDA criticize the European sys- tem as being less stringent, but I do not agree with this. There are no more products recalled in Europe than in the U.S., and there are stringent quality management systems that continue after CE mark approval has been granted, and companies are audited annually to ensure compliance." "Because of the difference in cost, CE marking is a milestone that comes much earlier in the commer- cialization process for almost all companies," Dr. Reinstein said. Hoping for an easier regulatory future While there are whispers of the FDA possibly easing regulatory restric- tions and Europe tightening them, some on the forefront of research advocate for a regulatory environ- ment that supports them. Ieva Sliesoraityte, MD, PhD, is a principal investigator for the EUR-USH project (European young investigators network for Usher syndrome). To date, there is a significant Usher syndrome diagnosis assess- ment delay due to the differences in the ages of onset in the clinical symptoms and the rare disease character. Dr. Sliesoraityte is search- ing for sensitive markers for early detection of Usher syndrome and developing an associated database that would be utilized for future therapy trials. "We lack early diagnostic mark- ers, and the majority of phenotype assessment methods in Usher syn- drome are not child-friendly," she said. The EUR-USH project has the potential to be finalized with novel psychophysical methods or device development that might be used for early detection of retinal degenera- tions; a CE mark would be an essen- tial prerequisite. Early diagnosis of the syndrome supports parents in their choice for cochlear implants instead of sign language learning. "I tend to believe that the regulatory process should be as smooth as possible and not a battle for innovation. In addition, there should be minimal regulatory restrictions for a CE mark when dealing with rare diseases, as we are focused on improving the quality of life for Usher syndrome patients," Dr. Sliesoraityte said. EW Editors' note: Dr. Reinstein has financial interests with Carl Zeiss Meditec. Dr. Sliesoraityte has no finan- cial interests related to her comments. Contact information Alvarez: info@istarmed.com Reinstein: dzr@londonvisionclinic.com Romano: fromano@eyetechcare.com Sliesoraityte: ieva.sliesoraityte@inserm.fr Trenary: russ@innfocusinc.com EW International June 2014 55 International outlook T here will always be innovation, and this is what leads to the next new thing. As clinicians we ask ourselves if the next new thing is a good idea. The answer will determine if the product or device is successful in the market. Before we get to that point, however, the device, drug, or technology must be proven to be safe and effective. This is where the FDA comes in. To enter the U.S. market, a new device has to undergo a rigorous clinical trial. In Europe the burden of proof involves primarily establishing safety, a process that takes considerably less time. The conse- quence is that product innovation cycles are accelerated. In this month's column, we compare the regulatory environment in Europe with that of the U.S. to help us understand how this impacts the availability of new technology. John A. Vukich, MD, international editor 55 International_EW June 2014-DL_Layout 1 6/3/14 12:42 PM Page 55

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