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CRSToday Europe News – May 2009
The EMEA and FDA: A Comparison
The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) share similar objectives, including "promoting and protecting public health, evaluating the safety and efficacy of therapeutic products, working collaboratively with outside experts, reducing the regulatory burden through international harmonization, providing regulatory and health information, and enhancing product development."1 However, these regulatory bodies differ in structure and benefit/risk assessment.
The FDA is a centralized agency that oversees the drug development process in a single nation, whereas the EMEA is a decentralized body that manages the process in many European nations. In the FDA, drug evaluation applications and the drug development process are monitored by the FDA's own staff, while in the EMEA, the assessment is conducted by the national agencies of the member states.1,2 According to the EMEA Web site, the agency brings together the scientific resources of more than 40 national competent authorities in 30 European Union (EU) and European Economic Area (EEA)-European Free Trade Association (EFTA) countries in a network of more than 4,500 European experts.3
Under both regulatory bodies, the drug development process includes preclinical testing; clinical trials with phase 1, 2, and 3 testing; and a final approval procedure. In the United States, an investigational new drug (IND) application is filed with the FDA for drugs that appear safe in the preclinical phase. In the EU, an application for a marketing authorization license is filed with the EMEA, which is valid in all EU member states, plus the EEA-EFTA countries of Iceland, Liechtenstein, and Norway. This centralized authorization procedure is mandatory "for all medicinal products developed by biotechnologic process; for new active substances indicated for the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder, or diabetes; and also for designated orphan medicinal products."1
For drugs that do not fall under these categories, companies may apply for a centralized marketing authorization if the drug constitutes a significant therapeutic, scientific, or technical innovation. Other authorization procedures—the national procedure, decentralized procedure, and mutual-recognition procedure—exist for drugs that do not fall within the scope of the centralized procedure.
Although the FDA and the EMEA have similar evaluation processes, the final outcome of the benefit/risk assessment is not necessarily the same in all cases. New drug clinical investigations in the United States compare the drug with a placebo. In the EU, benefit/risk assessment has become increasingly based on comparisons between the new and existing drugs. However, this is not always the preferred method of benefit/risk assessment. For example, a three-arm study using placebo and an active treatment as controls is preferable in the EU, when possible.1
Despite the differences between these regulatory bodies, the FDA and EU recently standardized the orphan medicines designation process. In an effort to simplify part of the orphan medicines designation process, in November 2007, the EU and the FDA adopted a common application form for drugs for rare diseases in both jurisdictions. According to the EMEA and FDA, rare diseases are defined as those affecting fewer than five in 10,000 people in the EU and fewer than 200,000 people in the United States. This common application format allows sponsors to apply to both jurisdictions at the same time with one application.
Tell us how what you think about the differences between the EMEA and the FDA. E-mail your comments to jkreatsoulas@bmctoday.com and we will include them in the June issue of CRST Europe.
Inexpensive Procedure Saves Sight in Developing Countries
David F. Chang, MD, the 2009 Binkhorst Lecturer at the American Society of Cataract and Refractive Surgery Symposium on Cataract, IOL and Refractive Surgery (ASCRS) in San Francisco,1 presented the audience with three hospital models that have successfully treated a high volume of cataract patients in a cost-effective manner. The title of Dr. Chang's lecture was, "The Greatest Challenge to Cataract Surgery. Needed: 5-Minute, $15 Cure for Blindness."
"In the developed world, who, other than ophthalmologists, can better appreciate just how daunting the challenge of reducing global blindness is?" Dr. Chang asked. "In developing countries, the obstacles include the high cost of phaco and foldable IOL technology, a critical shortage of ophthalmologists, and insufficient educational infrastructure to train novice phaco surgeons, let alone those skilled enough to tackle the advanced cataracts typically encountered."
Three programs—the Aravind Eye Care System in southern India, the Tilganga Eye Centre in Kathmandu, Nepal, and Project Vision in China—have overcome these obstacles by offering fast, low-tech, high-volume cataract surgery in ways that maximize the resources available in their areas. At Aravind, a single surgeon performs 12 to 16 procedures per hour. These programs "offer real hope for reducing the global burden of cataract blindness," Dr. Chang explained.
"The surgical solution is low tech—a manual extracapsular cataract extraction performed through a temporal, sutureless small incision. Equally important are the ability to manufacture affordable, low-cost IOLs, viscoelastics, and supplies and the streamlining of the surgical process through the use of standardized protocols executed by well-trained ancillary staff," he said. "Such cost containment and efficiency maximize the productivity of the system's most precious asset—the cataract surgeon."
Most important, the extracapsular procedure is affordable, Dr. Chang explained. For example, the five Aravind Eye Hospitals have used this technique for years to provide charitable cataract surgery at a cost of less than $15 per case. Charitable procedures account for roughly 200,000 annual cataract surgeries performed within the Aravind system. Research has shown that the complication rates for manual small-incision cataract surgery are low and that the procedure effectively restores vision in these populations.
The Aravind, Tilganga, and Project Vision centers are training surgeons from other developing countries to perform high-volume, manual small-incision cataract surgery methods. "We in the West need to help sustain this movement with financial and educational support," Dr. Chang advised.
In closing, Dr. Chang thanked the leaders of Aravind, Tilganga, and Project Vision "for their continually reminding me that, despite the fact that our own society, based on declining reimbursement, seems to value what we do less and less…good cataract surgeons remain one of the most precious and valuable assets for any society."
Rayner Receives Prestigious Queen's Award for Enterprise
Rayner Intraocular Lenses Ltd. (Hove, United Kingdom) received the Queen's Award for Enterprise for the company's sustained international trade in overseas markets and growing commercial success. The Queen's Award for Enterprise is the United Kingdom's most prestigious awards for business performance in international trade, innovation, and sustainable development. The awards are given each year by the Queen, on the advice of the Prime Minister, who is assisted by an advisory committee that includes representatives from government, industry and commerce, and the trade unions.
"The award is a testament to our commitment to medical and scientific advancement, because without new lenses and new applications for IOL technology we can't grow the business," Donald J. Munro, Chairman and Managing Director of Rayner, said in a company news release. "I'm confident that with this award, more than ever, the Rayner management and employees share the vision to remain innovative and explore new markets, to ensure we can continue to improve the quality of people's lives, restoring sight."
Alcon Donates to Blindness Prevention Charity
The Alcon Foundation, the philanthropic interest of Alcon, Inc. (Huenenberg, Switzerland), has donated a $50,000 grant to Mercy Ships, a global charity that has operated a fleet of hospital ships in developing nations since 1978.
The grant will support two 3-month Mercy Ships Alcon Fellowships. These are surgical fellowships in advanced cataract techniques for expatriate or national West African surgeons onboard the hospital ship in Cotonou, Benin, West Africa. In addition to the grant, Alcon will donate equipment and disposable ophthalmic supplies to Mercy Ships, a news release said.
Since 1997, Alcon has reportedly donated more than $5.6 million of equipment, supplies, and pharmaceuticals to support Mercy Ships efforts to address preventable blindness.
New OCT Software, Next-Generation Laser Introduced
Carl Zeiss Meditec, Inc. (Dublin, California), introduced upgraded versions of the Cirrus HD-OCT and Stratus OCT software and the next generation of the VisuMax femtosecond laser at the ASCRS meeting in San Francisco in April.
The newest version of Cirrus HD-OCT 4.0 includes features to support cataract and refractive surgeons as well as advanced analyses for tracking change in glaucoma and managing retinal disease. The 4.0 software has been released internationally and is pending FDA clearance.
The Stratus OCT 6.0 upgrade includes enhanced repeat function, multislice reports, and anterior segment imaging, which is pending 510k approval in the United States, according to the company.
The new 500-kHz VisuMax Femtosecond System is more than twice the speed of the 200-kHz system. Treatment times are reduced from approximately 20 to 25 seconds to just 10 seconds per eye. Laser spot density has also reportedly been increased by approximately 20%, facilitating more consistent flap lifts and smoother stromal beds. The 500-kHz upgrade works with the existing VisuMax platform with no programming modifications required by the surgeon, the company said.
Corneal Health Stable at 3 Years After Phakic IOL Implantation
Corneal health and cell morphology were stable at 3 years after implantation of the AcrySof Phakic Angle-Supported IOL (Alcon Laboratories, Inc., Fort Worth, Texas), according to results of a multicenter phase 3 study analyzed by Michael C. Knorz, MD.1 Dr. Knorz is the Founder and Medical Director of the FreeVis LASIK Center at the University Medical Center and a Professor of Ophthalmology at the University of Heidelberg, Medical Faculty, both in Mannheim, Germany. He is also a member of the CRST Europe Editorial Board. Dr. Knorz won best poster at the 2008 American Academy of Ophthalmology Annual Meeting in Atlanta for this research.
Phase 3, nonrandomized, open-label, single-arm studies were conducted in Europe (n=190 patients), Canada (n=120 patients), and the United States (n=50 patients) and included patients implanted with the AcrySof Phakic Angle-Supported IOL. All patients were 18 years or older and had high but stable myopia, the study said. First eye follow-up results were reported at 1 (n=338), 2 (n=204), and 3 (n=105) years.
Central and peripheral endothelial cell density (ECD) changes were consistent with expected normal ECD loss (-10%), Dr. Knorz said. Annual mean percent change in central and peripheral ECD were also within the expected limits for chronic loss (-2%). The rate of ECD loss reportedly declined over time.
The mean central and peripheral endothelial cell percent hexagonallity was relatively unchanged at postoperative visits compared with baseline, Dr. Knorz reported. Slight decreases in cellular variation were observed postoperatively when compared with the preoperative visit. However, central ECD increased over time. Chronic endothelial cell acitivity was stable for ECD, percent hexagonality, and coefficient of variation at the 3-year visit, according to the study.
Dr. Knorz recommended that ECD be evaluated annually, or more frequently if ECD losses are observed. Long-term evaluations of the clinical effects of ECD and cell morphology following implantation of the AcrySof Phakic Angle-Supported IOL are ongoing, he said.
Michael C. Knorz, MD, is a consultant to Alcon Research, Ltd.
Femtosecond Laser Introduced
Stephen G. Slade, MD, presented a paper at the March 2009 Dulaney Aspen Invitational Refractive Symposium (AIRS) on the femtosecond laser for refractive cataract surgery being developed by LenSx Lasers Inc. (Aliso Viejo, California). The LenSx laser is designed to liquefy, soften, or chop the nucleus; perform a perfectly sized and centered capsulotomy; and create all-corneal incisions.
In his presentation, Dr. Slade, medical director of LenSx Lasers, presented results from two clinical studies. The initial clinical studies, conducted by Zoltan Nagy, MD, Associate Professor at Semmelweis University in Budapest, included more than 125 eyes. All laser capsulotomies were well centered and 100% were within 0.2 mm of the intended diameter. The laser capsulotomies were removed with no radial tears or adverse events. A second study evaluated the use of the LenSx laser for lens liquefacation (ie, softer cataracts) and lens fragmentation (ie, harder cataracts). In 26 patients with softer lenses, the nucleus was effectively liquefied and removed with the I/A tip only. Twenty-one patients with hard lenses were treated with laser lens fragmentation, which reduced the need for sculpting by prechopping the nucleus.
"Any way to safely and precisely perform all the incisions, capsulotomy, and handle the nucleus would be important to the future of refractive cataract surgery," Dr. Slade commented. "Currently, only about 5% of all cataract patients are in the premium channel either due to patients declining or not being offered the technology. I believe that femtosecond laser-assisted refractive cataract surgery could be a key to increasing adoption of the premium cataract channel."
– Compiled by Jennifer Kreatsoulas, PhD, News and Contributing Editor
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