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Recent Developments in the Vision Care Industry BSS RECALL The US FDA issued a recall for a common brand of balanced salt solution used in cataract surgery made by Cytosol Laboratories.The agency cited problems with elevated levels of endotoxin that could cause a wide variety of serious reactions such as fever, shock and changes in blood pressure and other circulatory functions. The FDA noted that more than 300 patients developed problems including Toxic Anterior Segment Syndrome (TASS). Physicians and consumers have been instructed to discontinue using all products made between December 2003 and December 2005, under three labels:“AMO Endosol,” distributed by Advanced Medical Optics, Inc. (AMO);“Cytosol Ophthalmics,” distributed by Cytosol Ophthalmics; and “Akorn,” distributed by Akorn, Inc. (www.fda.gov/medwatch) DisCoVisc goes to Brazil Alcon launched its viscosurgical product DisCoVisc (sodium chondroitin sulfate 4%, sodium hyaluronate 1.65%) on the Brazilian market during the World Ophthalmology Congress in Sao Paulo.The product is intended for use during all stages of anterior segment surgery.The product combines the properties of cohesive and dispersive viscoelastic agents. (www.alconlabs.com) Macugen goes to Europe Pfizer has announced that the European Commission has granted marketing authorisation for Macugen® (pegaptanib sodium injection) for the treatment of neovascular (wet) age-related macular degeneration. Macugen is the first therapy indicated in Europe for the treatment of all types of wet AMD, regardless of lesion subtype, size or visual acuity.The approval was based on the results of two pivotal clinical trials involving 1,186 patients with all subtypes of wet AMD.The drug was approved in the US in December 2004.The company launched the product in Latin America during the World Ophthalmology Congress in São Paulo, Brazil. (Macugen.com) New ORK-CAM from Schwind Schwind eye-tech-solutions launched a new version of its ORK-CAM diagnostic system. The ORK Workstation integrates the topography system for measurement of Journal Watch corneal wavefront, and the aberrometer for the measurement of ocular wavefront, at one workplace.The wavefront data of the cornea and the entire eye are synchronised and calculated.The doctor manages data measurement with both devices from one Panel-PC, while the patient merely changes chin rests.The system includes a wireless LAN connection. (www.eye-tech-solutions.com) Glaucoma combo Alcon advanced one step closer to European approval of its DuoTrav solution (travoprost 0.004%/timolol 0.5%) after gaining a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).The approval sets the stage for marketing authorisation of DuoTrav eye drops solution in the European Union to decrease IOP in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.The marketing authorisation is expected to be finalised in the second quarter of 2006. DuoTravTM eye drops solution is approved in Australia and is also under review in other countries. Alcon estimates the European glaucoma market to be more than $1.1bn, with almost 10% of the market comprised of combination prostaglandin analogue products. In order to accelerate product acceptance, the company will actively pursue reimbursement in each of the 25 EU member countries. (www.alconlabs.com) IntraLase keratoplasty IntraLase Corp. announced the successful performance of the first corneal transplant cases using the IntraLase® FS laser.The company said that the use of IntraLase’s femtosecond laser to create a contoured, full-thickness corneal resection in preparation for corneal transplant has the potential to make corneal transplantation a safer, more precise procedure as the alllaser approach gains favour among transplant surgeons. Full global launch of this new therapeutic application is expected in Autumn 2006. (www.intralase.com) by Sean Henahan Vision science highlights from the world’s leading journals of medicine and science Blue light special? Do yellow-tinted intraocular lenses really provide any additional benefit to cataract patients? Blue-light filtering IOLs now on the market were designed to filter out light in the blue end of the spectrum believed to be particularly destructive to aging RPE cells. The hypothesis is that such lenses would potentially protect against the development of macular disease. JCRS Editor Emanuel Rosen FRCSE evaluates the science behind these claims in an editorial. He notes that the literature on the contribution of UV and blue light to the degeneration of the macula through deleterious effects on the central retinal pigment epithelium and photoreceptors is equivocal. He adds that it would be difficult if not impossible to design the appropriate clinical case-control studies. After reviewing the current state of the debate, including a recent presentation by Dr Mainster in Lisbon raising the spectre of diminished scotopic sensitivity with blue-blocking IOLs, Dr Rosen concludes that for the moment the best philosophy is “Be safe rather than sorry”. Dr Rosen was inspired in part by an article in the JCRS by Prof John Marshall that presents clinical results of a currentgeneration blue-light-filtering intraocular lens. Two hundred and ninety-seven patients in a multicentre prospective randomised patient-masked study received the Acrysof Natural IOL or the Acrysof single-piece IOL.The study found no statistically significant differences between the two patient groups in visual acuity, contrast sensitivity evaluated under mesopic and photopic conditions or the number of patients who passed the Farnsworth D-15 colour perception test. There were no lens-related adverse events in either group. The authors note: “Additional long-term studies should be able to show whether the lens actually provides the theoretical benefits to retinal health.” E Rosen, JCRS, ‘A l'oeil malade la lumiere nuit’, December 2005, Vol. 31, Issue 12, 2237-2238. J Marshall et al., JCRS, ‘Clinical results of the blue-light filtering Acrysof Natural foldable acrylic intraocular lens’, December 2005,Vol. 31, Issue 12, pages 2319-2323. Glaucoma pandemic forecast The global toll of glaucoma is set to reach 60 million by 2010, rising to almost 80 million by 2020, a new analysis suggests. The authors reviewed all the data on glaucoma derived from studies based on populations. These figures were then used to calculate rates of the disease by age, sex and ethnicity, in combination with United Nations projections for world population. Based on their calculations, the authors predict that 8.5 million people will be blind in both eyes as a result of glaucoma by 2010, a figure that will rise to more than 11 million people by 2020. They believe women, and people living in Asia, Africa and India will be worst affected. The authors cite the urgent need to improve diagnostic and therapeutic approaches to open- and closed-angle glaucoma that could be applied around the world. An accompanying editorial points out that efforts to tackle the disease have been hampered by a lack of consensus on the definition of the disease and the absence of a simple and accurate screening test. HA Quigley et al., BJO,‘The number of people with glaucoma worldwide in 2010 and 2020’, 2006; 90: 262-7. RRA Bourne, BJO,‘Worldwide glaucoma through the looking glass”, 2006; 253-4. Humour declines with age Aqueous humour volume declines steadily with age, a longitudinal Swedish study indicates. Researchers evaluated the aqueous humour and corneal volumes, correlations to age, sex and refractive status of 153 eyes of healthy volunteers and 58 eyes of cataract surgery candidates. They followed 16 patients for four years.The study found that the aqueous humour volume was inversely correlated to the age of the individual, with an average decrease of 1.4ml per year. They observed that the posterior part of the anterior chamber underwent a pronounced reduction in volume with time, whereas the volume of the anterior part increases slightly with time. Increasing age also brought increasing steepness and peripheral thinning of the cornea and a reduction in corneal volume. The authors note that these alterations could be of importance in planning refractive procedures and in evaluating disease processes. M Jonnson et al., Acta.Ophth. Scan., ‘Slit-scan tomography evaluation of the anterior chamber and corneal configurations at different ages’, February 2006, Volume 84, 116. Two genes play role in majority of AMD Two genes, Factor H and Factor B, have been found to play a role in nearly 75% of cases of AMD. The current work builds on research released last year showing the importance of the Factor H gene in AMD pathogenesis. Researchers now report that a second gene, Factor B, may work in tandem with Factor H. Both are believed to play roles in regulating the immune inflammatory response. EuroTimes will discuss this work in detail in the May 2006 issue. B Gold, et al., Nature Genetics, ‘Variation in factor B (BF) and complement component 2 (C2) genes is associated with age-related macular degeneration’, March 2006,Adv. Online Publication. EuroTimes April 2006