EyeWorld Asia-Pacific March 2012 Issue

March 2012 16 EW FEATURE International advantage: Surgeons enjoy more premium IOL options, but still look to the U.S. for innovative ideas by Jena Passut EyeWorld Staff Writer AT A GLANCE • Doctors in Europe have a wider range of choices when it comes to premium lenses • Some practitioners blame the slow U.S. FDA approval process • Doctors in the U.S. discuss the latest innovations and eagerly await their approval there Regional differences in the development of IOLs T he U.S. has long been known for its innovation in ophthalmology, but the lack of availability of advanced IOLs in the country means the premium lens market seems to be lagging behind its European counterparts. Surgeons who spoke to EyeWorld agreed that fewer lenses here put surgeons at a disadvantage. “We have quite a big stock of lenses,” said Tobias Neuhann, MD , medical director, Marienplatz Eye Clinic and Opera House Cooperative Medical Care Centre, Munich, Germany, who has more than 30 years of experience implanting IOLs in the country. “The whole world used to go to meetings in the States because the evolution of these lenses came from the States. All the brilliant ideas still come from there, but there is the FDA. A lot of American ophthalmologists, friends, and so-called opinion leaders hate to talk about that because they know [other countries] have things available that [the U.S.] doesn’t have.” Erik L. Mertens, MD , FEBO , medical director and eye surgeon, Medipolis, Antwerp, Belgium, uses two such lenses frequently—the diffractive trifocal FineVision IOL (PhysIOL, Liége, Belgium) and the bifocal Lentis MPlus (Oculentis, Berlin; Topcon Europe, Rotterdam, the Netherlands). “The distance vision is very good,” he said. “The visual quality is very good, much better than other premium lenses or other multifocal lenses.” Dr. Mertens said that having more choices means that European surgeons are currently at an advantage over their American colleagues. “IOLs are a well-established technology in cataract surgery and refractive lens exchange,” Dr. Mertens said. “When surgeons have more ability, more models, they can better select the IOL model that is the best choice for a patient, taking into account the patient’s daily activities, and so on.” Carl Zeiss Meditec (Jena, Germany) has the Acri.Tec line, which is a small-incision toric multifocal. Rayner (East Sussex, England) has a hydrophilic acrylic toric multifocal and toric multifocal aspheric Sulcoflex lenses, which are additive lenses, for piggybacking in pseudophakic patients, according to Mark Packer, MD , clinical associate professor of ophthalmology, Casey Eye Institute, Oregon Health & Science University, Portland, Ore., USA. “There’s a lot of technology available in Europe, and many of these companies have no plans to bring these to the U.S. because of the hurdles of FDA approval and the expense that entails,” Dr. Packer said. “I think they’d love to do it if it was a little easier and if success was more assured, but unfortunately, in today’s climate, that’s just not possible.” What Europeans are using Dr. Mertens said his American colleagues often ask him about the Lentis MPlus. “The multifocal concept is well established in the States with the ReSTOR [Alcon, Fort Worth, Texas, Hungwon TCHAH, MD Professor, Department of Ophthalmology, Asan Medical Center, University of Ulsan 388-1 Pungnab-dong Songpa-gu, Seoul, 138040 Korea Tel. no. +82-2-30103680 Fax no. +82-2-4706440 hwtchah@amc.seoul.kr W here are we, Asians? Do we have full access to new innovative medical devices, or are we barely able to access these technologies? That is a tough question to answer. If you look around and look at your neighboring countries, you can easily understand why that is a tough question to answer. The Asia-Pacific region is different from the U.S. and Europe in every aspect, which includes the medical regulatory system. The U.S. is a large single nation, in which the same medical regulation system is working all over the country. And Europe also has the European Union, which controls the basic system of medical regulation in most Western European countries. There is, however, neither an agreement nor a similar organization to control the medical regulation system over the Asia-Pacific region. The medical regulation system is different from country to county. For example, as far as I recall, regulation process for approval of medical device is much faster and less complicated in Singapore and Australia compared to that in Korea and Japan. There are too many countries in this region, so a generalization cannot be made about the accessibility of new technologies and the national medical regulatory system. Nonetheless, I think, in general, the Asian stance, in terms of access to new medical technology, is somewhere in between Europe and the U.S., maybe slightly skewed to Europe. In Korea, we have Korean FDA (KFDA) that controls all regulatory processes for medical devices and drugs. When the medical device is produced in Europe, CE approval is needed and if it is produced in U.S., then U.S. FDA approval is needed to pass the regulatory process in Korea. None of the devices that are not approved in their region and country of origin can be approved in Korea. So, American products have some disadvantages in Korea because approval processing in the U.S. by the U.S. FDA usually takes longer compared to CE approval in Europe. But at the same time, it has advantages also because the KFDA wants the results of tests which are very similar to those required by the U.S. FDA. So, once approved by the U.S. FDA, then it is less complicated to acquire approval from KFDA. So far, premium IOLs available in Korea are Restor (Alcon), ReZOOM and Technis Multifocal IOL (Abbott Medical Optics, Santa Ana, Calif., USA), Crystalens (Bausch + Lomb, Rochester, NY, USA), Acri-Lisa (Carl Zeiss), Lentis Mpus (Simovison, Tervuren, Belgium), OptiVis (Aaren Scientific, Ontario, Calif., USA), WIOL (Medicem, Kamenné Žehrovice, Czech Republic), Sulcoflex (Rayner), etc. They all work reasonably well. Each IOL has its own advantages and disadvantages, and doctors should have options to maximize treatment results. In that sense, we Asians are fortunate to have access to new innovative technology rather easily compared with our colleagues in America. But, we are worried about the current trend in which many countries in Asia are trying to strengthen the medical regulatory system and adding more processes to pass the tests for safety. There is no doubt that the safety issue is the No. 1 priority in the medical field. But we should also remember that the only absolutely safe procedure is no procedure. Editors’ note: Prof. Tchah has no financial interests related to his comments. Views from Asia-Pacific