At Press Time
Abbott to Acquire Visiogen
Synchrony accommodating IOL is key to purchase.
■ Abbott has announced a definitive agreement to acquire Visiogen, Inc. for $400 million in cash, providing its Abbott Medical Optics division with a next-generation accommodating intraocular lens technology to address presbyopia for cataract patients. Visiogen's Synchrony IOL has completed clinical trials in the United States and is currently under review by the FDA with approval anticipated in 2010. If approved, the Synchrony would compete directly with Bausch & Lomb's already-commercialized accommodative Crystalens.
Visiogen is a privately held company based in Irvine, Calif, with European operations in Karlsruhe, Germany. Abbott entered the vision care segment following its February 2009 acquisition of Advanced Medical Optics.
“This acquisition demonstrates Abbotts continued commitment to vision care and our desire to introduce and accelerate technologies that have the ability to make a difference in the lives of millions of people around the world,” said John M. Capek, executive vice president of Medical Devices, Abbott. “Combining Visiogen's accommodating lens technology with Abbotts existing medical optics portfolio expands our ability to offer a diverse set of refractive options to our ophthalmic customers and the patients they serve.”
“We are thrilled to join forces with Abbott to bring this much-anticipated technology to market,” said Reza Zadno, founder, CEO and president of Vsiogen. “The global clinical results with Synchrony are extremely encouraging, and the opportunity to leverage Abbott Medical Optics' extensive commercialization infrastructure means that many more patients will benefit from this exciting advancement in cataract and presbyopia correction.”
Synchrony accommodative intraocular lens from Visiogen.
Visiogen's Synchrony accommodating IOL is designed to deliver improved vision at all distances, potentially eliminating the need for glasses or contact lenses, reducing glare and nighttime halos, and improving contrast sensitivity.
Visiogen has said that the Synchrony is a significant advancement in artificial lens technology. The unique design of the Synchrony lens is designed to mimic the eye's natural capacity to change focus, with the potential to deliver a full range of vision. Synchrony has been implanted in more than 1,200 eyes and has been the subject of extensive clinical studies both in the United States and internationally. Synchrony has received CE mark designation and has been available commercially in Europe since January 2009.
“Visiogen's Synchrony lens allows Abbott Medical Optics to enter the growing accommodating IOL segment and enhances our premium IOL portfolio that includes the Tecnis Multifocal lens,“ said Jim Mazzo, senior vice president, Abbott, and president, Abbott Medical Optics.
This transaction is subject to customary closing conditions and regulatory approvals and is expected to close in the fourth quarter of 2009. This transaction does not impact Abbott's previously issued earnings-per-share guidance for 2009.
| In the News… |
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■ Response to erythromycin shortage. The FDA and CDC have asked healthcare professionals to reserve current supplies of erythromycin ophthalmic ointment for neonatal prophylaxis use and use alternative drugs such as AzaSite, Gentak and Tobrex for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin, as well as for treatment of post-surgical and post-traumatic events. Erythromycin ophthalmic ointment is a macrolide antibiotic routinely used in neonates for prophylaxis of ophthalmia neonatorum, a form of bacterial conjunctivitis that may be contracted by newborns during delivery. If not treated, the infection can be serious and may lead to blindness. Erythromycin ophthalmic ointment was recently placed on the FDA Drug Shortages Web site list, which was developed to respond to drug shortages that may have a significant impact on public health. ■ DSEK deemed safe and effective. Descemet's stripping endothelial keratoplasty (DSEK) corneal transplant procedure is a safe and effective treatment for corneal endothelial diseases, says a 2009 review by the cornea panel of the American Academy of Ophthalmology's Ophthalmic Technology Assessment Committee. The panel, led by Barry Lee, MD, reached this conclusion through a comprehensive review of pertinent studies published from 1980 to 2009. An estimated 85% of corneal transplants performed in the United States are associated with endothelial diseases. In outcome comparisons derived from the review, DSEK was superior to penetrating keratoplasty (PK) — the dominant procedure prior to DSEK's development — in terms of earlier recovery and stability of vision, refractive status after surgery and specific risks and complications associated with surgery and recovery. The most common DSEK complications apparently do not hinder ultimate recovery of vision in most patients. DSEK and PK outcomes were similar in terms of survival of the transplanted cornea, visual acuity and endothelial cell loss, and specific surgical risks and complication rates. “The focus of future research should be clinical studies, to set expectations for long-term endothelial cell survival and to determine acceptable complication rates, so we can further improve DSEK and obtain the best possible outcomes for patients,” Dr. Lee said. “Another important research area is improving tissue preparation and surgical techniques to increase endothelial cell survival,” he added. ■ Bepreve approved for ocular itching. Ista Pharmaceuticals said the FDA has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older. Two phase 3 double-masked, placebo-controlled, conjunctival allergen challenge studies demonstrated that Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve's rapid onset of action. ■ Herpetic keratitis drug gets OK. Sirion Therapeutics said the FDA has approved its Zirgan (ganciclovir ophthalmic gel) 0.15% as a topical treatment for acute herpetic keratitis (dendritic ulcers). Sirion said it expected the drug to be available early next year. Herpetic keratitis is caused by the herpes simplex virus (HSV) and is a significant cause of corneal blindness and a leading indication for corneal transplantation in the United States, with approximately 50,000 new and recurrent cases each year. After the initial outbreak, HSV becomes a latent infection in the trigeminal ganglion or cornea, with repeated recurrences that frequently lead to corneal scarring and ocular inflammation, increasing the risk of blindness. ■ Alcon acquires biotech company. Alcon has entered into a definitive agreement to acquire ESBATech AG, a Swiss biotechnology company. ESBATech is a clinical-stage biotechnology company that has been developing a pipeline of proprietary single-chain antibody fragment therapeutics for topical and local delivery. “Biotechnology offers significant growth opportunities in ophthalmology because it has the potential to deliver therapies with superior efficacy and safety relative to existing approaches,” said Sabri Markabi, MD, Alcon's senior vice president of research & development and chief medical officer. ESBATech has advanced its antibody fragment technology to preclinical and clinical stages in the eye for various diseases with its most advanced product candidate progressed into phase 1 and 2 studies for the treatment of inflammatory ocular diseases. In other news, Alcon announced that CMS has approved the inclusion of the AcrySof IQ Toric IOL in the Reduced Spherical Aberration class of New Technology Intraocular Lenses (NTIOL). The NTIOL designation increases the Medicare payment to ASCs for cataract surgery by $50 when surgery is performed with an AcrySof IQ Toric IOL. |
Pars Plana Placement of Glaucoma Shunts
This approach eliminates the issue of endothelial cell loss.
By Jerry Helzner, Senior Editor
The pars plana procedure, done in conjunction with a vitrectomy performed by a retina specialist, eliminates the issue of major endothelial cell loss and also removes any annoying floaters.
The Korean study, reported in the American Journal of Ophthalmology, involved 41 glaucoma refractory eyes implanted with the Ahmed Glaucoma Valve in anterior-site procedures. The researchers found an average of 22.6% endothelial cell loss in the supratemporal area after 24 months and a 15.4% endothelial cell loss in the central corneal area, also after 24 months.
“Historically, the pars plana has been used as an alternative site for tube placement in specific situations such as neovascular glaucoma and for patients with corneal compromise,” says Andrew Rabinowitz, MD, glaucoma specialist for the Barnet, Dulaney Perkins practice based in Phoenix. “The success I have had in cases in which the tube was placed in the pars plana, coupled with this new data on endothelial cell loss, lead me to suggest that the indications for pars plana placement of the tube should be expanded to include a broader spectrum of glaucomas.”
Dr. Rabinowitz says pars plana placement may be beneficial in patients who have any history of uveitis or intraocular inflammation. Additionally, patients with significant rheumatoid arthritis have been noted to have erosion of the scleral patch graft and conjunctiva overlying the tube at the limbus. He says this erosion places the patient at risk for hypotony and endophthalmitis.
“In these cases, if the tube is removed from the anterior chamber and placed in the pars plana, this erosion can be eliminated as it is a phenomenon seen primarily at the limbus and not more posterior.” Finally, Dr. Rabinowitz notes that patients who have had cataract surgery with vitreous loss, or who have had an anterior chamber intraocular lens placed, would be excellent candidates for pars plana placement. In these cases, he says that pars plana placement allows for a lower incidence of side effects, including inflammation and vitreous obstruction of the tube.
“Overall, I see a trend toward greater application of pars plana tube placement in cases that would previously have been placed in the anterior chamber,” he concludes.
New World Medical, the manufacturer of the Ahmed Glaucoma Valve, confirms that pars plana placement of its shunts has traditionally been limited to patients with neovascular glaucoma and corneal issues. However, the company cites a study reporting that 72.5% to 94% of refractory cases in which pars plana implantation was employed achieved satisfactory IOP control without further glaucoma surgery.
Equipment Deductions Peak in 2009
The reason for pushing up these purchases, which cover a broad range of business-related equipment, is that the Section 179 federal tax deduction was increased to $250,000 (on total lease or purchase of business equipment up to $800,000) by the Economic Stimulus Act of 2008 and later extended until the end of this year. The Section 179 deduction will revert back to a maximum of $125,000 in 2010.
There is also a 50% bonus deduction good until December 31, 2009, that can be taken on the remainder of the value of the equipment after the initial Section 179 deduction is calculated. Thus, if the total value of the equipment purchased and installed in 2009 is $800,000, the initial Section 179 deduction is $250,000 and the 50% bonus deduction can be taken on the remaining $550,000.
“Basically, if a practice is planning to obtain big-ticket equipment, it may be wise to investigate the possibility of doing it this year,” says Mark Kropiewnicki, Esq., LLM, of The Healthcare Group in Plymouth Meeting, Pa. “To qualify for the deduction, the equipment must be in service by December 31. The Section 179 deduction will still be in effect in 2010, just at a reduced level.”
Practices should be aware that just signing a contract in 2009 for installation of an EMR system, for example, does not qualify for the deduction. The system must be up and running by year-end to qualify for the deduction.
Gordon Siteman of Lombart Instruments suggests that practices should consider taking advantage of the additional tax break available until the end of the year.
“It is wise to invest in your practice and let Uncle Sam help you pay for your equipment rather than pay 35% federal tax on the (extra) income you earn,” he asserts.
Practices interested in obtaining complete information about Section 179 deductions should visit the informative Web site www. section179.org or check with their accountant.
Research Digest
New & Noteworthy Journal Articles
Compiled by Andrew E. Mathis, PhD, Medical Editor
► Preventing immune rejection of corneal transplants. Although corneal transplantation has been performed for a century now, grafts are still rejected by the body's immune system. Two German ophthalmologists address this issue in the August 2009 Acta Ophthalmologic, providing a review of recent advances in prevention of tissue rejection.
Drs. Uwe Pleyer and Stephan Schlickeiser of the Charité University Berlin cover the full range of immune responses to corneal transplants, concluding that the introduction of histocompatibility agents, via either indirect or direct pathways, can be helpful in preventing graft rejection. They further conclude that use of a direct pathway may be more beneficial in a higher-risk situation. Finally, they stress the need to focus on both local and systemic immune mechanisms for greater success.
► Lifestyle glaucoma prevention. The leadoff article in the August 2009 issue of The Journal of Glaucoma details several preventive measures patients at risk for primary open-angle glaucoma may take to stave off the disease. While ocular hypertensive therapy is the only proven prevention technique, Louis R. Pasquale, MD, of the Massachusetts Eye and Ear Infirmary, and Jae Hee Kang, ScD, of the Harvard Medical School, suggest that emphasis on lifestyle factors such as exercise, diet and smoking may have a preventive effect on increasing IOP.
Drs. Pasquale and Kang also focus on as yet unidentified environmental risk factors in their article, suggesting, for instance, a possible link between alcohol use and POAG. They suggest that clinical trials need to be undertaken to consider possible risk factors and identify whether they truly have an effect on the development of glaucoma in patients at risk.
► A new application for OCT? A team of Japanese eye surgeons may have found a new use for OCT in ophthalmology. The team monitored a cause of fungal endophthalmitis in an 82-year-old patient using the technology that has been used primarily to track cases of AMD and diabetic retinopathy. They reported their findings in the September 2009 issue of Acta Ophthalmologic. The authors did not specify whether they used Fourier-domain or time-domain OCT technology.
The doctors found, while monitoring the progress of a Candida endophthalmitis infection on OCT, that they were able to gather data previously available only by analyzing tissue samples. Furthermore, OCT was able to detect a protrusion on the retinal pigment epithelium that could not have been detected by biopsy. This discovery suggests that treatment of fungal endophthalmitis with antifungal drugs may allow the RPE to provide a temporary barrier against damage to the retina. More research is needed, but OCT appears to be a promising diagnostic for use in endophthalmitis cases.
► Trace element a possible link to glaucoma. An editorial in the September 2009 issue of The British Journal of Ophthalmology suggests that a trace element available in many multivitamins could be associated with glaucoma. Anthony King, MD, of the Department of Ophthalmology at Queen's Medical Centre in Nottingham, England, suggests that there may be a link between patients taking selenium supplements and their likelihood of developing glaucoma.
Dr. King cites, among other sources, the Nutritional Prevention of Cancer clinical trial data, which included evidence that volunteers enrolled in the trial who were given supplemental selenium had a higher hazard ratio for developing glaucoma, and this ratio increased when enrollees chose to continue selenium supplementation.
Nevertheless, Dr. King urges caution when counseling patients on alleviating glaucoma symptoms. Besides the fact that data definitely linking selenium intake to glaucoma are lacking, selenium has also been linked to a decrease in certain types of cancer. It also acts as an antioxidant. “I will be thinking about selenium,” Dr. King says of advising patients, “but not mentioning it just yet.”
► Link between diabetes and AMD. According to findings published in the August 2009 issue of The British Journal of Ophthalmology, European patients with neovascular AMD are more likely to have diabetes than patients who do not suffer from AMD. The EUREYE study, which enrolled over 4,000 volunteers from seven European nations, half of them control subjects, yielded data to the extent that patients with wet AMD are almost twice as likely to self-report for diabetes.
Of the patients enrolled, 13.1% reported that they had diabetes; however, the rate of diabetes in patients with wet AMD was 19.3%. While the percentage difference may, at first, appear small, the statistical analysis performed by the study authors indicated: (1) that patients with wet AMD were 1.75 times more likely to have diabetes compared to the control group, who did not have AMD in any form; and (2) that the difference was highly statistically significant (P=0.016). When the data were adjusted for lifestyle factors, the rate of diabetes in wet AMD patients went up to 1.81.
This finding was at stark odds with patients with dry AMD. The study authors found no relationship between earlier, dry stages of AMD or with geographic atrophy. The authors suggest that there may be a link between a patient having a history of diabetes and his or her likelihood of developing wet AMD. Furthermore, they suggest that the two forms of the disease may have different pathogeneses, suggesting the need for distinct treatments for wet and dry AMD. More research is warranted, however. OM
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