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CRSToday Europe News – November/December 2009
CRST Europe Chief Medical Editor Awarded 2009 Choyce Medal
Cataract & Refractive Surgery Today Europe's Co-Chief Medical Editor Sheraz M. Daya, MD, FACP, FACS, FRCS(Ed), received the 2009 Choyce Medal and delivered the Choyce Medal Lecture 2009 at the United Kingdom and Ireland Society of Cataract and Refractive Surgeons (UKISCRS) in October 2009. This award, presented every 2 years to an ophthalmologist who has made a significant contribution to the field in Europe, is named after Peter Choyce, MD, a pioneer of artificial lens implantation following cataract extraction, and founding member of the International Intraocular Implant Club (IIIC). Diane Choyce, the widow of the late Mr. Choyce, presented the medal to Dr. Daya.
Dr. Daya is Medical Director and Consultant in the Corneoplastic Unit and Eye Bank at the Queen Victoria Hospital, East Grinstead, United Kingdom, as well as Founder and Medical Director of Centre for Sight in London and East Grinstead. He has been involved in innovative work in cornea, anterior segment and keratorefractive surgery. Dr. Daya's lecture outlines his many wide-ranging contributions at the East Grinstead's Corneoplastic unit over the past 16 years, including stem cell transplantation, particularly ex vivo stem cell transplantation and lamellar grafting and its applications beyond conventional transplantation.
"It is very flattering to be awarded this honor, especially following so many well-known recipients, including Richard Lindstrom, MD, under whom I was a fellow in 1991," Dr. Daya said in an interview with CRST Europe. "Preparing this lecture made me realize the wide spectrum of work carried out at the Corneoplastic Unit over the last 16 years. This award is a tribute to all the fellows and staff who have been so supportive and open to innovation and change.
"The unit has grown considerably, especially over the last 7 years, with the inclusion of two more consultant colleagues: Raman Malhotra, FRCOphth, who provides oculoplastic expertise and, more recently, Damian Lake, MB ChB(Glas), FRCOphth, in the area of cornea," Dr. Daya commented. "Based on feedback I have received, many colleagues were unaware of the depth and breadth of work conducted at our unit. I am pleased I had the opportunity to convey this to my colleagues."
Publisher of CRST Europe Launches News Web Site
Bryn Mawr Communications LLC, the publisher of Cataract & Refractive Surgery Today Europe, Cataract & Refractive Surgery Today, Glaucoma Today, Retina Today, and Eyetube.net, recently launched Eyewiretoday.com, a Web site devoted to covering breaking news for the ophthalmic industry. The site will provide ophthalmic-specific content as well as links to relevant news from newspapers, blogs, medical journals, vision publications, and academic and medical studies. Eyewiretoday.com will also provide employers and prospective employees in the ophthalmic industry a venue for networking, offering a means of sharing job opportunities. The Web site also promotes consulting, public relations, and other related services to industry as well as physicians. For more information, contact Stephen Daily, Digital Media Editorial Director, at tel: +1 484 581 1871 or e-mail: sdaily@bmctoday.com.
Optical Biometer Receives FDA Clearance
Haag-Streit USA (Mason, Ohio) received US Food and Drug Administration (FDA) clearance for the Lenstar LS 900 and introduced the device to the US market at the Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco. The Lenstar LS 900 is the first optical biometer to utilize optical low-coherence reflectometry.
B&L Strikes Deals With Two European Companies
Bausch & Lomb (Rochester, New York), announced that it has acquired Tubilux Pharma Group S.p.A. (Pomezia, Italy), a privately held ophthalmic pharmaceuticals company that develops and distributes products for antiinfective and antiinflammatory use, dry eye, and glaucoma in Italy and 30 other countries. Under the terms of this agreement, Bausch & Lomb acquired Tubilux's ophthalmic pharmaceuticals portfolio and its commercial and sales operations.
Croma Pharma GmbH (Korneuburg, Austria) granted rights to several Bausch & Lomb subsidiaries to co-promote and sell bromfenac ophthalmic solution in Europe, pending approval of the drug by the European Medicines Agency (EMEA).
Bromfenac, an NSAID for postoperative ocular inflammation and pain following cataract extraction, is already approved in the United States and Japan and is marketed there by other companies. Once the drug is approved, Bausch & Lomb's subsidiaries will reportedly gain the rights to sell bromfenac in all European Union member states plus Belarus, Croatia, Montenegro, Norway, Russia, Serbia, Switzerland, Turkey, and Ukraine. Croma and Bausch & Lomb will market bromfenac in Austria, France, Poland, Romania, and Spain.
Abbott Completes Visiogen Acquisition
Abbott (Abbott Park, Illinois) completed its $400 million cash purchase of Visiogen, Inc. (Irvine, California), on October 20, 2009.
The acquisition will provide Abbott with Visiogen's Synchrony accommodating IOL, which is currently under review by the FDA. The lens received Conformitˇ Europˇene (CE) marking and has been available commercially in Europe since January 2009.
Rhein Medical Introduces Instruments to Position Malyugin Ring
Rhein Medical, Inc. (St. Petersburg, Florida), recently introduced the Steinert Malyugin Ring Manipulator and Krausz Malyugin Ring Manipulators.
Developed in coordination with Roger F. Steinert, MD, the Vice Chair of Clinical Ophthalmology and the Director of Cataract, Refractive, and Corneal surgery at the University of California, Irvine, the Steinert Malyugin Ring Manipulator is designed to fit into the holes of the Malyugin Ring (MicroSurgical Technology, Redmond, Washington) for easier placement of the ring inside of the iris.
Developed in coordination with Howard Krausz, PhD, MD, of the Escondido Medical Eye Clinic in Escondido, California, the Krausz Malyugin Ring Manipulators engage the Malyugin Ring scrolls by cupping the coil with a miniature spoon. According to the company, the instrument enables manipulation of the ring scrolls in three dimensions—anterior and posterior as well as in the iris plane. The double-ended instrument works for both right- and left-side scrolls and spreads the scroll coils to facilitate pupil engagement and release. The Krausz Malyugin Ring Manipulators can be used through a cataract incision to manipulate side scrolls or through a sideport incision for proximal and distal scrolls.
OCT News, Research, and Education Resource for Eye Care Professionals
Carl Zeiss Meditec, Inc. (Dublin, California), recently introduced an online resource on optical coherence tomography (OCT) for the eye care industry. According to a company news release, Eye On OCT (www.oct.zeiss.com) features news and education about OCT technology and clinical applications for ophthalmologists, optometrists, and other eye care professionals.
Resources available on Eye On OCT include physician demonstrations, interviews, and commentary about current OCT applications in ophthalmology and optometry; links to peer-reviewed OCT-related journal articles and breaking news articles; case reports and educational presentations; and a gallery of OCT images. Other resources include spotlight stories on physicians, academic centers, and companies involved in OCT research and development, as well as a calendar of OCT educational and training seminars and an e-mail newsletter.
Coherent's German Excimer Manufacturing Facility Receives ISO Certification
Coherent Inc. (Santa Clara, California) recently expanded its ISO 13485 certification in Europe to include the excimer laser design and manufacturing facility located in Goettingen, Germany, according to a news release. ISO 13485 is an international standard that defines the requirements of comprehensive quality management systems for the design, development, production, customer service, and assembly of medical devices. ISO 13485 specifies protocols for adherence to customer requirements and product improvement within the European regulatory framework for medical devices.
Good Outcomes With Sutureless Manual Cataract Extraction
Sutureless large-incision manual cataract extraction (SLIMCE) is a safe and effective technique for manual cataract extraction, according to researchers at the Chinese University of Hong Kong.1 The study was published in the Archives of Ophthalmology.
The researchers retrospectively reviewed 50 consecutive patients who underwent SLIMCE. Three months postoperatively, all patients had a BCVA of at least 20/60, and 37 had a BCVA of at least 20/30. Additionally, UCVA was at least 20/68 in 28 patients and was between 20/80 and 20/200 in 22 patients. Significant intraoperative complications were not encountered, and sutureless wounds were achieved in 48 patients, the researchers said. Endothelial cell loss was 3.9%, and the mean amount of surgically induced astigmatism was 0.69 D.
"In view of its low cost, SLIMCE may have a potential role in reducing cataract blindness in developing countries," the investigators concluded.
Risk Factors for Preoperative Bacterial Contamination
Patients with local or systemic risk factors or advanced age may have a higher rate of bacterial conjunctival contamination before surgery, according to a prospective masked study in the European Journal of Ophthalmology.1
Researchers at Ludwig-Maximilians-University in Munich, Germany, divided patients (n=1,474) undergoing intraocular surgery into four groups: control (n=282; without local or systemic risk factors), local risk factors (n=503; chronic use of topical medications, contact lens wear, blepharitis, chronic eyelid or conjunctival inflammation), systemic risk factors (n=545; immunosuppression, diabetes, autoimmune conditions, and asthma), and those with both types of risk factors (n=144).
Preoperative conjunctival cultures showed that 914 bacteria were isolated from 214 patients. Advanced age was associated with a higher rate of positive conjunctival cultures (P<.005); however, a statistical difference was not found with regard to gender (P=.7). Fourteen patients in the control group had a positive conjunctival culture. Positive conjunctival cultures were found in 118 patients with local risk factors (P<.0001), 65 patients with systemic risk factors (P=.0019), and 22 patients with both (P=.0006).
Voclosporin-Based Uveitis Therapy Successful in International Trials
Results of international phase 2/3 clinical trials showed that LX211 (voclosporinn; Luveniq; Lux Biosciences, Inc., Jersey City, New Jersey) controlled ocular inflammation and reduced the rate of recurrence in eyes with noninfectious uveitis, according to a news release. Luveniq, licensed by Lux Biosciences from Isotechnika, Inc. (Edmonton, Alberta, Canada), is a next-generation calcineurin inhibitor intended for use as an oral immune-modulatory agent to treat systemic forms of noninfectious uveitis.
Patients were randomized to receive 0.2, 0.4, or 0.6 mg/kg of voclosporinn twice daily or placebo at sites in seven countries (the United States, Canada, the United Kingdom, France, Germany, Austria, and India). The LX211-02 trial, which included 232 patients with clinically quiescent uveitis, showed that the 0.4 mg/kg twice daily dose reduced the recurrence of inflammation 50% more than placebo (P<.05). This suggests that LX211 may effectively increase the interval between inflammatory relapses to 24 months compared with 10 months with placebo.
Results of the LX211-01 study, which investigated LX211 in 218 patients with active noninfectious posterior uveitis, evaluated control of inflammation by mean change in vitreous haze at weeks 16 and 24. The 0.4 mg/kg twice-daily dose of LX211 was statistically significantly superior to placebo at both time points, and preservation of vision was also demonstrated. In terms of ocular safety, the 0.4-mg/kg twice daily dosage demonstrated a safety profile suitable for chronic use. Adverse effects associated with the dosage included minor renal complications and a mean increase of 6 mm Hg in systolic blood pressure. Abnormal hair growth (ie, hirsutism) was observed in 5% of patients. Overall, the safety profile was similar to placebo, and triglycerides and cholesterol were not elevated.Lux Biosciences reportedly plans to file for US and European approval of LX211 by the end of the year.
BETA-BLOCKERS, CATARACTS LINKED
Topical and oral beta-blocker medications are associated with a higher incidence of nuclear cataract and cataract surgery, according to a study in the British Journal of Ophthalmology.1
Researchers at the Centre for Vision Research in Sydney, Australia, examined 3,654 individuals. At the 5- and 10-year follow-up, 2,454 participants were reexamined. Questionnaires on use of medications were evaluated, and lens photographs were taken and graded at each visit. At 10 years, the use of either oral or topical beta-blockers had a borderline association with nuclear cataract and significantly predicted incident cataract surgery after adjusting for age, gender, blood pressure, intraocular pressure, myopia, diabetes, smoking, and steroid use. "Apart from an association between angiotensin-converting enzyme inhibitors and incident cataract surgery, no other antihypertensive medications were found to predict incident cataract or cataract surgery," the authors concluded.
—Compiled by Jennifer Kreatsoulas, PhD, News and Contributing Editor
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