Month: May 2014

Optic nerve sheath meningiomas are rare tumors that are traditionally treated with surgery, which is typically a blinding procedure. However, researchers from Thomas Jefferson University Hospital have found that a specialized type of radiation therapy offers the same local control, with fewer adverse effects on vision. The investigators presented their data at the 51st ASTRO Annual Meeting (Abstract #2676/B-261).

Fractionated stereotactic radiotherapy is a more precise, targeted type of radiation therapy that allows an effective dose of radiation to tumor, but helps spare other structures around it. In the case of optic nerve sheath meningiomas, the eye lens and brain cells are spared, according to Robert Den, M.D., a resident in Radiation Oncology at Thomas Jefferson University Hospital.

“Fractionated stereotactic radiotherapy is beneficial because it is a non-invasive means to achieve disease control, while allowing patients to continue with their daily lives without being hindered by a major surgical procedure,” Dr. Den said.

Dr. Den and colleagues conducted a retrospective analysis of 58 patients with optic nerve sheath meningiomas who were treated with fractionated stereotactic radiotherapy between 1996 and 2006. They reviewed patient charts for technical radiotherapy information and for treatment outcomes, which included local control, visual acuity and acute and late toxicity related to treatment. The median follow-up was 70 months.

Based on MRI, the radiographic local tumor control was more than 95%. Visual acuity was stabilized or improved in 92% of patients. Four patients had worsening vision. One patient developed optic neuritis and one developed central retinal venous occlusion. There were no grade-3 or higher late complications.

“This was the largest U.S. cohort of patients with optic nerve sheath meningiomas treated with fractionated stereotactic radiotherapy,” said Dr. Den. “There is no difference in outcome and the patients’ quality of life was much better. This should be the standard of care for patients with optic nerve sheath meningiomas.”

Source: Emily Shafer

Thomas Jefferson University

Thermage(R), Inc.
(Nasdaq: THRM) today announced that the Food & Drug Administration (FDA)
provided a first-time-ever 510 (k) clearance for the non-invasive treatment
of periorbital wrinkles and rhytids, including upper and lower eyelids.
Thermage’s proprietary ThermaCool(R) system, utilizing customized
ThermaTip(TM) treatment tips, is the only medical device in the
non-invasive skin tightening category with this clearance.

“Thermage is the first and only company to receive FDA clearance for
non-invasive eyelid treatments,” said Stephen J. Fanning, president and
chief executive officer at Thermage. “We believe that the clinical data
supporting this milestone further defines Thermage as the gold standard in
non-invasive skin tightening and contouring, differentiating our
technology, safety profile and efficacy from other companies in the
aesthetic market.”

Eyes by Thermage(TM) is one of several treatment procedures provided by
Thermage. The procedure was launched in March 2006 under the FDA general
clearance for the non-invasive treatment of wrinkles and rhytids. This
exclusive treatment reduces hooding, improves skin texture and tone, and
smoothes the eye area. To date, more than 20,000 procedures have been
completed worldwide and clinicians in 27 countries have been trained on
Eyes by Thermage with approved procedure guidelines. The specific FDA
clearance for eyelids is based on a multi-center clinical study conducted
in the United States and Canada.

“This is a landmark event in the non-invasive aesthetics industry as no
other device has a specific eyelid indication,” said Brian Biesman, M.D.

Consumers are seeking cosmetic improvements but due to demanding
lifestyles, downtime is often not an option. According to recent reports
from the American Society for Aesthetic Plastic Surgery, non-invasive
aesthetic procedures are a rapidly growing alternative to cosmetic surgery
with eyelid surgery as one of the top five procedures performed during
2006. Physicians can now be assured that by offering patients Eyes by
Thermage, the only FDA cleared non-invasive alternative to eyelid surgery,
they are providing an effective and desired treatment for the reduction of
wrinkles.

About Thermage, Inc.

Thermage’s innovative technology provides a unique non-invasive
procedure designed to tighten and contour skin, significantly expanding the
non-invasive aesthetic applications physicians can offer to the rapidly
growing “anti-aging” market. The company commercially launched its flagship
ThermaCool(R) system in 2002 when it received clearance from the U.S. Food
& Drug Administration. Today, the ThermaCool system is available in 80
countries; more than 400,000 patients have been treated with Thermage and
approximately 2,000 dermatologists, plastic surgeons and other cosmetic
physicians are using the Thermage(R) procedure worldwide.

This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Specifically, statements concerning our belief that we are the gold
standard of non-invasive skin tightening and contouring and our estimate of
the number of Eyes by Thermage(TM) procedures performed constitute such
forward-looking statements. Forward-looking statements are based on
management’s current, preliminary expectations and are subject to risks and
uncertainties, which may cause Thermage’s actual results to differ
materially from the statements contained herein. Actual results may be
affected by a number of factors, including the introduction of other
medical devices for the non-invasive treatment of eyelids. Further
information on potential risk factors that could affect Thermage’s business
are detailed in the Company’s Form 10-Q for the period ended March 31,
2007. Undue reliance should not be placed on forward-looking statements,
which speaks only as of the date they are made. Thermage undertakes no
obligation to update publicly any forward-looking statements to reflect new
information, events or circumstances after the date they were made, or to
reflect the occurrence of unanticipated events.

Thermage and ThermaCool are registered trademarks of Thermage, Inc.
ThermaTip and Eyes by Thermage are trademarks of Thermage, Inc.

Thermage, Inc.
thermage

The National Academy of Sciences (NAS) will honor 18 individuals with awards recognizing extraordinary scientific achievements in the areas of astronomy, biology, medicine, chemistry, geology, oceanography, physics, and psychology. These outstanding scientists have made fundamental contributions to human knowledge, including a near-infrared survey of the entire sky, the discovery of the first statin for lowering cholesterol, and insights into how the human visual system learns to recognize objects.

The awards and recipients for 2007 are:

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ALEXANDER AGASSIZ MEDAL – a medal and a prize of $15,000 awarded every three years for original contributions in the science of oceanography – goes to JAMES R. LEDWELL, senior scientist, department of applied ocean physics and engineering, Woods Hole Oceanographic Institution, Woods Hole, Mass., “for innovative and insightful tracer experiments using sulfur hexafluoride to understand vertical diffusivity and turbulent mixing in the open ocean.” The medal was established by a gift of Sir John Murray and has been awarded since 1913.

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JOHN J. CARTY AWARD FOR THE ADVANCEMENT OF SCIENCE – a medal and a prize of $25,000 awarded annually for noteworthy and distinguished accomplishment in any field of science (plant science in 2007) – goes to JOSEPH R. ECKER, professor, plant biology laboratory and genomic analysis laboratory, Salk Institute for Biological Studies, La Jolla, Calif., “for contributions in the areas of ethylene signal transduction and ARABIDOPSIS genomics that have paved the way for a revolution in modern agriculture.” The award was established by the American Telephone & Telegraph Co. in honor of John J. Carty and has been awarded since 1932.

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ALEXANDER HOLLAENDER AWARD IN BIOPHYSICS – a prize of $20,000 awarded every three years for outstanding contributions in the field of biophysics – goes to BARRY H. HONIG, investigator, Howard Hughes Medical Institute, and director, center for computational biology and bioinformatics, Columbia University, New York City, “for pioneering theoretical and computational studies of electrostatic interactions in biological macromolecules and of the energetics of protein folding.” The award was established by the bequest of Henrietta W. Hollaender in honor of her husband, Alexander W. Hollaender, and has been presented since 1998.

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JESSIE STEVENSON KOVALENKO MEDAL – a medal and a prize of $25,000 awarded every three years for important contributions to the medical sciences – goes to JEFFREY M. FRIEDMAN, investigator, Howard Hughes Medical Institute, and Marilyn M. Simpson Professor, laboratory of molecular genetics, Rockefeller University, New York City, “for the discovery of leptin and its role in the regulation of appetite, energy expenditure, and the molecular mechanisms underlying obesity.” The award was established by a gift of Michael S. Kovalenko in memory of his wife, Jessie Stevenson Kovalenko, and has been presented since 1952.

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RICHARD LOUNSBERY AWARD – a medal and a prize of $50,000 awarded to French and American scientists in alternate years for extraordinary scientific achievement in biology and medicine – goes to XIAODONG WANG, investigator, Howard Hughes Medical Institute, and George L. MacGregor Distinguished Chair in Biomedical Science, department of biochemistry, University of Texas Southwestern Medical Center, Dallas, “for pioneering biochemical studies on apoptosis, which have elucidated a molecular pathway leading into and out of the mitochondrion and to the nucleus.” The award was established by Vera Lounsbery in memory of her husband and has been presented since 1979.

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NAS AWARD IN CHEMICAL SCIENCES – a medal and prize of $15,000 awarded annually for innovative research in the chemical sciences that, in the broadest sense, contributes to the better understanding of the natural sciences and to the benefit of humanity – goes to ROBERT G. BERGMAN, Gerald E.K. Branch Distinguished Professor, department of chemistry, University of California, Berkeley, “for numerous innovative contributions at the interfaces of physical, organic, and inorganic chemistry, including the discoveries of alkane carbon-hydrogen bond oxidative addition and 1,4-benzene diradicals.” The award, supported by the Merck Company Foundation, has been presented since 1979.

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NAS AWARD FOR CHEMISTRY IN SERVICE TO SOCIETY – a prize of $20,000 awarded biennially for contributions to chemistry, either in fundamental science or its application, that clearly satisfy a societal need. The award, given in alternate years to chemists working in industry and to those in academia, government, and nonprofit organizations (presented to a chemist working in industry in 2007) – goes to ARTHUR A. PATCHETT, retired vice president, medicinal chemistry, Merck Research Laboratories, Rahway, N.J., “for innovative contributions in discoveries of Mevacor, the first statin that lowers cholesterol levels, and of Vasotec and Prinivil for treating hypertension and congestive heart failure.” The award, established by E.I. du Pont de Nemours & Co., has been presented since 1991.

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NAS AWARD FOR INITIATIVES IN RESEARCH – a prize of $15,000 awarded annually to recognize innovative young scientists and to encourage research likely to lead toward new capabilities for human benefit (the 2007 field is optical science) – goes to SHANHUI FAN, assistant professor, department of electrical engineering, Stanford University, Stanford, Calif., “for innovative research on the theory and applications of photonic crystal devices.” The award, presented since 1981, was established by AT&T Bell Laboratories in honor of William O. Baker, and is supported by Alcatel-Lucent.

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NAS AWARD IN MOLECULAR BIOLOGY – a medal and a prize of $25,000 awarded annually for a recent notable discovery in molecular biology by a young scientist – goes to GREGORY J. HANNON, investigator, Howard Hughes Medical Institute, and professor, Watson School, Cold Spring Harbor Laboratories, Cold Spring Harbor, N.Y., “for elucidation of the enzymatic engine for RNA interference.” The award is supported by Pfizer Inc and has been presented since 1962.

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NAS AWARD IN THE NEUROSCIENCES – a prize of $25,000 awarded every three years for extraordinary contributions to progress in the fields of neuroscience – goes to JEAN-PIERRE CHANGEUX, emeritus professor, Institut Pasteur and Coll??ge de France, Paris, “for the pioneering discovery that fast-acting neurotransmitters mediate their effects through allosteric regulation of the neurotransmitter protein.” The award was established by the Fidia Research Foundation and has been presented since 1988.

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NAS AWARD FOR SCIENTIFIC REVIEWING – a prize of $10,000 awarded annually for excellence in scientific reviewing within the past 10 years (the 2007 field is astronomy) – goes to GEOFFREY R. BURBIDGE, professor, department of physics, University of California, San Diego, “for contributions as editor of THE ANNUAL REVIEW OF ASTRONOMY from 1974 to 2004, using his vast knowledge to make it the premier astronomy review journal worldwide.” The award is supported by Annual Reviews Inc., the Institute for Scientific Information, and THE SCIENTIST in honor of J. Murray Luck and has been presented since 1979.

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TROLAND RESEARCH AWARDS – a research award of $50,000 given annually to each of two recipients to recognize unusual achievement and to further their research within the broad spectrum of experimental psychology – goes to RANDY L. BUCKNER, investigator, Howard Hughes Medical Institute, and professor, FAS Department of Psychology and center for brain science, Harvard University, Cambridge, Mass., and to PAWAN SINHA, associate professor of computational neuroscience, department of brain and cognitive science, Massachusetts Institute of Technology, Cambridge. Buckner was chosen “for substantive contributions to understandings of the neural mechanisms of memory formation and retrieval.” Sinha was chosen “for elucidating how humans learn to recognize visual objects, and for developing computational models of the mechanisms that mediate this learning.” The Troland Research Awards were established by a bequest from Leonard T. Troland and have been presented since 1984.

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SELMAN A. WAKSMAN AWARD IN MICROBIOLOGY – a prize of $5,000 given biennially to recognize excellence in the field of microbiology – goes to RICHARD M. LOSICK, professor, biological laboratories, Harvard University, Cambridge, Mass., for “discovering alternative bacterial sigma factors and his fundamental contributions to understanding the mechanism of bacterial sporulation.” The award was established by a gift of the Foundation for Microbiology and has been presented since 1968.

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CHARLES DOOLITTLE WALCOTT MEDAL – a medal and a prize of $10,000 given every five years to encourage and reward individual achievement in advancing our knowledge of Cambrian or Precambrian life and its history in any part of the world – goes to JOHN P. GROTZINGER, Fletcher Jones Professor of Geology, department of geological and planetary sciences, California Institute of Technology, Pasadena, “for the insightful elucidation of ancient carbonates and the stromatolites they contain, and for meticulous field research that has established the timing of early animal evolution.” The award was established by a gift of Mrs. Mary Vaux Walcott in memory of her husband and has been presented since 1934.

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JAMES CRAIG WATSON MEDAL – a medal and a prize of $25,000 plus $25,000 to support the recipient’s research, given every three years for contributions to the science of astronomy – goes to MICHAEL F. SKRUTSKIE, professor, department of astronomy, University of Virginia, Charlottesville, and ROC M. CUTRI, deputy executive director, infrared processing and analysis center, California Institute of Technology, Pasadena, “for their monumental work in developing and completing the Two Micron All-Sky Survey, thus enabling a thrilling variety of explorations in astronomy and astrophysics.” The award was established by the will of James C. Watson and has been presented since 1887.

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Also to be honored at the April 29 ceremony is MAXINE F. SINGER, president emeritus, Carnegie Institution of Washington, who was chosen to receive the Academy’s PUBLIC WELFARE MEDAL. The Academy selected Singer “for providing inspired and effective leadership in matters of science and its relationship to education and public policy.” The medal was established to recognize distinguished contributions in the application of science to the public welfare and has been presented since 1914.

The National Academy of Sciences is a private, nonprofit honorific society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Since 1863, the National Academy of Sciences has served to “investigate, examine, experiment, and report upon any subject of science or art” whenever called upon to do so by any department of the government.

Contact: Maureen O’Leary

The National Academies

View drug information on Mevacor; Prinivil or Zestril.

Guided by families with an unusual number of cases, scientists at Johns Hopkins have discovered the genetic origins of at least one form of Fuchs corneal dystrophy, FCD, the leading reason for corneal transplantation in the United States.

In one form or another, FCD’s trademark deterioration of the cells covering the clear, outermost lens of the eye affects more than 4 percent of the population over 40. Late in life, the dystrophy causes swelling of the cornea and can severely affect vision, making it impossible to see well even with glasses or contact lenses. It’s believed that various forms of FCD are due to multiple gene mutations.

In a report in the September issue of Investigative Ophthalmology, a team led by Hopkins ophthalmologist John Gottsch, M.D., says they were able to map a common form of Fuchs, found most often in women, to chromosome 18.

“Finding this chromosomal locus is putting us in the right neighborhood to find culprit genes,” says Gottsch. “Now we have to start knocking on every door.”

Gottsch is heartened by success with earlier Fuchs gene-hunting studies. The Hopkins group tracked down its first FCD-related gene in a Virginia family with multiple, early onset cases. That gene, labeled COL8A2, was mapped to chromosome 1.

Prior to that, a large Indiana family with FCD, including a boy of 10, led the team to yet another gene variant, on chromosome 13.

The scientists use linkage analysis, a process-of-elimination gene-hunting technique that analyzes inheritance patterns in families with relatively large numbers of affected individuals and trace genetic traits co-inherited or “linked” with the disorder. Researchers search for a common location for all the linked traits until they wind up with a single chromosome address.

In his latest study, Gottsch used not only linkage analysis but also a method of identifying variations in DNA sequences to examine three FCD families in which 43 members had the disease and 33 did not. He and his coworkers were able to narrow down the linked traits in all three families to the short arm of chromosome 18 (the whole “address” is 8q21.2-q21.32).

“Because the same location popped up for three different families with similar forms of Fuchs dystrophy, we believe we have the chromosome locus for the most common genetic mutation resulting in Fuchs,” he said. “It’s a painstaking process of elimination, but now we are closing in on the gene that causes what we believe is the most widespread form of Fuchs, not just the rare types in individual families. Our methods have clearly shown that Fuchs is not just one disease, but rather a disorder with several genetic flavors.”

Gottsch became interested in FCD more than six years ago when he treated a woman with a corneal dystrophy of unknown origin that looked remarkably similar to FCD despite slightly different symptoms. “I knew it wasn’t classic Fuchs, but rather something new,” remembers Gottsch. “In the end, it wasn’t Fuchs at all, but a sort of mutated distant cousin of the disease. It made me wonder, however, if there were more genetic variants of the disease out there.”

He stopped wondering a few years later when he examined the Indiana family and discovered what he thought at the time was the youngest case of FCD ever described in the scientific literature, the 10-year-old boy. However, literature published 25 years ago described a Virginia family with a 3-year-old girl with the disease. Gottsch contacted the original investigator and was able to reexamine the family. He was then able to determine the gene that afflicted this family and that it resulted in a unique and severe form of FCD.

“I knew Fuchs was not one but several diseases with multiple genes involved when I started comparing the symptoms of the two families,” Gottsch says. “The Indiana family members developed their disease late in life, women were mostly affected, and those who were had large bumps, or guttae, on the back of the cornea. The Virginia family had severe early disease with men and women equally affected, and the cornea had smaller, finer bumps.”

Gottsch is looking to one day use various gene therapies to suppress the mutations that he has found. It is hoped that someday the millions of people who suffer from FCD in the United States will eventually benefit from having the genetic basis of their disease identified and gene therapies developed. At present, corneal transplantation is the only solution for those severely affected.

Contact: Jeff Ventura

Johns Hopkins Medical Institutions

This month’s Ophthalmology, the journal of the American Academy of Ophthalmology, includes a research review of the effects of Vitamins C and E and magnesium on diabetic retinopathy and findings from the first large study of vision problems in Hispanic and African-American infants and young children.

Can Supplements Help People with Diabetes Avoid Retinopathy?

In theory, Vitamins C and E and magnesium could help prevent or limit diabetic retinopathy (DR), a potentially blinding disease, since each nutrient causes the body to respond in ways that alter retinopathy mechanisms. For example, in animal models Vitamins C and E suppress production of a growth factor, VEG-F, which can promote abnormal blood vessels in the retina. And high dietary levels of magnesium are associated with lower blood pressure and blood sugar, both of which correlate with a lower risk of retinopathy. A research team led by Amanda Adler, MD, PhD, Institute of Metabolic Science, Cambridge, United Kingdom, surveyed studies published from 1988 through 2008 on the impact of these micronutrients on DR. Based on 15 selected studies comprising 4,094 individuals, Dr. Adler says the evidence is not strong enough yet to recommend Vitamins C or E or magnesium supplements for patients with diabetes. She thinks the research should continue, though, and recommends specific parameters.

“It is a very attractive proposition that what one eats, rather than a medication, might reduce the risk of diabetic complications. Ideally, future studies would include frequent measurement of intake of these three nutrients through diet and supplements, standardized exams to identify DR, and agreed-upon biomarkers to assess DR progression,” Dr. Adler said. “If such studies showed apparent protection against DR, then a randomized clinical trial could determine more precisely how a person with diabetes might, or might not, alter his intake of any of these nutrients,” she said.

The Adler survey found that in hospital-based studies, participants with higher levels of Vitamin C in their blood were less likely to have DR, but in population-based studies there was no association between dietary intake of Vitamin C and DR. For Vitamin E, no studies showed an association between blood levels or dietary intake and DR risk. For magnesium, one study showed an association between low blood levels of magnesium and DR progression, but other studies were inconclusive.

Assessing Eyesight and Ethnic Group Norms in Young Children

How common are vision disorders in infants and young children, and do rates differ by ethnic group? The Multi-Ethnic Pediatric Eye Disease Study (MEPEDS) based at the Doheny Eye Institute, University of Southern California Keck School of Medicine, is the first large study to consider these questions in preschool-aged children. Rohit Varma, MD, MPH, and colleagues report their findings on refractive error, the leading cause of vision problems in young children. They studied the prevalence of myopia (nearsightedness), hyperopia (farsightedness) and anisometropia (a difference in refractive error between the two eyes) in more than 6,000 Hispanic and African-American children (about 3,000 per ethnicity) aged 6 to 72 months.

Overall, about 90 percent of the children were in the normal range (measured in eye exams as less than 1 diopter of myopia and greater than 4 diopters of hyperopia). African-American children were more likely to be myopic (6.6 percent) than Hispanic children (3.7 percent), and rates declined with age in both groups. MEPEDS results suggest that low-level myopia that improves with age may be normal, especially in African-American infants: 14 percent were myopic at 6 to 11 months, but only 4 percent at 48 months and older. Other studies show that myopia increases again in both groups in school-aged children. Hyperopia was more prevalent in Hispanic than in African-American children (26.9 versus 20.8 percent, respectively). Prevalence declined between ages 6 and 24 months, then stabilized or increased, indicating that not all children “grow out” of hyperopia. The 2-to-3 year old time period is also when eye misalignment (esotropia, one eye turned inward) is likely to occur, and the researchers think persistent hyperopia and the onset of esotropia may be related.

Anisometropia, defined as a difference of more than 1 diopter of refractive error between the two eyes, was found in 4 to 6 percent of preschoolers in both ethnic groups. Prevalence of this vision disorder declined between 6 months and 2 years, but remained fairly stable after age 2. Anisometropia is associated with strabismus (misaligned eyes) and with amblyopia, also called “lazy eye,” in which one eye increasingly does the work of seeing while the other loses vision. If a child with amblyopia receives early and consistent treatment, he or she usually regains normal vision.

“Preschool refractive error screening could detect many children with amblyopia related to anisometropia, so that treatment could be started early,” Dr. Varma said. “Studies are needed to further assess anisometropic changes over time and relate anisometropia levels to risk for developing amblyopia and strabismus, so that effective vision screening protocols can be developed.”

Source
American Academy of Ophthalmology

An estimated 96 million people in the United States wear prescription eyeglasses. According to researchers at Columbus
Children’s Research Institute (CCRI) on the campus of Columbus Children’s Hospital, during a two-year period of time, more
than 26,000 people were treated in U.S. emergency departments for eyeglasses-related injuries, and six percent of these
injuries resulted in admission to the hospital. Columbus Children’s Hospital researchers also found that the mechanism of
injury differed according to the age of the person wearing the eyeglasses. The findings were presented May 15, 2005, at the
Pediatric Academic Societies’ annual meeting in Washington, D.C.

“So many people wear eyeglasses, but until now, little was known about the injuries eyeglasses pose when broken,” said Huiyun
Xiang, M.D., M.P.H., Ph.D., the Center for Injury Research and Policy at CCRI and assistant professor of Pediatrics at The
Ohio State University College of Medicine and Public Health. “Analyzing the data, we were able to look at the mechanism of
injury by both gender and age, with a specific focus on injuries among children.”

The research found that more than 21 percent of the 26,000 injuries occurred in children between the ages of 2 and 17 years.
Among children 2 through 9 years, the leading mechanism of injury was falling (accounting for 55 percent of the injuries in
this age group). Among children between the ages of 10 and 17, nearly 40 percent of the injuries occurred because of sports
activities, and another 10 percent of their injuries occurred due to car accidents. Males and females were found to be
equally likely to sustain injuries (53 percent and 47 percent, respectively).

For the research, Xiang and his research team evaluated 2002 and 2003 data from the National Electronic Injury Surveillance
System which analyzes consumer product injuries. Each case of eyeglasses-related injury-identified by a code-was examined to
identify the cause of injury.

“These findings are important because by first understanding the mechanism of injury likely to affect children, we can begin
to look at safety measures to prevent the injuries, such as safer eyeglasses designs and use of safety goggles during
sports,” said Sara Sinclair, M.P.H., research assistant at the Center for Injury Research and Policy.

As follow-up to this study, the team will begin further examining the mechanisms of injury. For example, identifying the
sports participants were engaged in during the eyeglasses injury and car accident-related injuries.

Columbus Children’s ranks among the top 10 in National Institutes of Health research awards and grants to freestanding
children’s hospitals in the country and houses the Department of Pediatrics of The Ohio State University College of Medicine
and Public Health. With nearly 600,000 patient visits each year, Children’s Hospital is a 112-year-old pediatric healthcare
network treating newborns through age 21. In 2004, the Columbus Children’s Research Institute conducted more than 300
research projects and is the home of Centers of Emphasis encompassing gene therapy; molecular and human genetics; vaccines
and immunity; childhood cancer; cell and vascular biology; developmental pharmacology and toxicology; injury research and
policy; microbial pathogenesis; cardiovascular medicine; and biobehavioral health. Pediatric Clinical Trials International
(PCTI), a site management organization affiliated with the hospital, also coordinated more than 50 clinical trials. In
addition to having one of the largest ambulatory programs in the country, Children’s offers specialty programs and services.
More than 75,000 consumers receive health and wellness education each year and affiliation agreements with nearly 100
institutions allow more than 1,700 students and 500 residents to receive training at Children’s annually. More information on
Children’s Hospital of Columbus is available by calling (614) 722-KIDS (5437) or through the hospital’s Web site at columbuschildrens.

Columbus Children’s Hospital
Columbus, OH
United States
childrenscolumbus

Arf gene prevents excessive growth of blood vessels in the developing eye by blocking signals that trigger accumulation of cells that nurture these vessels, according to St. Jude researchers
A gene better known for its role in preventing cancer also plays a key role in the developing embryo, where the gene prevents excessive growth of blood vessels, according to investigators at St. Jude Children’s Research Hospital.

The gene, called Arf, prevents the accumulation of certain cells, called pericytes, that nurture the growth of blood vessels in the eye during embryonic development, the researchers said. This observation is of interest because Arf also works with a gene called p53 to trigger apoptosis–programmed suicide–in cells that have become cancerous. In the eye, however, Arf works through a second mechanism, independent of p53. The current discovery that Arf also restricts blood vessel growth in the eye of the embryo was a surprising finding because it was not linked to its known role in suppressing cancer, the researchers said.

A report on this discovery appears in the online issue of the European Molecular Biology Organization (EMBO) journal.

St. Jude investigators showed that the protein made by the Arf gene normally blocks signals that trigger the growth of pericytes. This blockage causes the network of blood vessels these cells nurture to degenerate. In the early embryo, this network, called the hyaloid vascular system, grows into the clear, jelly-like area of the eye called the vitreous, between the lens of the eye in front and the retina at the back of the eye. The network grows during the early part of eye development, after which the blood vessels die and the network disappears. When this network persists–as it does in the absence of Arf–it disrupts the ability of the developing eye to grow to its normal size–a disease called persistent hyperplastic primary vitreous. Children with this condition usually have abnormally small eyes and poor vision.

“The Arf gene is well known for its ability to sense when a cell is being overly stimulated to grow,” said Stephen X. Skapek, M.D., an assistant member of the Department of Hematology-Oncology at St. Jude. “Arf then helps to trigger a series of signals to block cell proliferation. In the developing eye, we’ve demonstrated that Arf also blocks signals that would otherwise cause pericytes to reproduce and support the continued growth of blood vessels in the developing eye.”

This new insight into the role of Arf was made possible by a laboratory model previously developed at St. Jude by a team led by Charles Sherr, M.D., Ph.D., and Martine Roussel, Ph.D., of the Genetics and Tumor Cell Biology Department (Zindy, F. et al., [2003] Proc Natl Acad Sci USA 100: 15930-15935).

“This model allowed us to observe the role of Arf in its natural environment and to determine its function by studying the consequence on the developing eye of both the presence and absence of this gene,” said Ricardo Silva, Ph.D., first author of the EMBO paper and the postdoctoral student in Skapek’s laboratory who did much of the work on the current project. “The results of our study might help guide the development of therapies for persistent hyperplastic primary vitreous.”

The discovery of the role of Arf in curtailing growth of blood vessels in the developing eye might also contribute to development of new anticancer drugs. “If we can figure out how to re-activate the Arf gene in human cancers in which this gene is repressed, we might be able to prevent the accumulation of perivascular cells that support the blood vessels that feed a tumor,” Skapek said. “A drug that lets us starve those solid cancers would be a powerful new weapon against cancer.”

The researchers showed that the Arf gene in the pericytes disrupts the hyaloid vascular system in the embryonic eye by blocking the cell’s ability to respond to a signaling molecule called platelet-derived growth factor ([Pdgf]-B). Pdgf-B triggers this signal by binding to a receptor called Pdgf-beta on the surface of the pericyte.

Other authors of the paper include J. Derek Thornton, Amy C. Martin, Jerold E. Rehg, David Bertwistle and Frederique Zindy. This work was supported in part by the American Cancer Society, the National Eye Institute and ALSAC.

St. Jude Children’s Research Hospital

St. Jude Children’s Research Hospital is internationally recognized for its pioneering work in finding cures and saving children with cancer and other catastrophic diseases. Founded by late entertainer Danny Thomas and based in Memphis, Tenn., St. Jude freely shares its discoveries with scientific and medical communities around the world. No family ever pays for treatments not covered by insurance, and families without insurance are never asked to pay. St. Jude is financially supported by ALSAC, its fund-raising organization. For more information, please visit stjude.

Carrie Strehlau
Carrie.Strehlaustjude
901-495-2295
St. Jude Children’s Research Hospital
stjude

The team, working with Sichuan University in Chengdu, China, investigated eye movements in Chinese and British people to further understanding of the brain mechanisms that control them and how they compare between different human populations. They found that a type of eye movement, that is rare in British people, is much more common in Chinese people, suggesting that there could be subtle differences in brain function between different populations.

Tests of eye movements can be used to help identify signs of brain injury or disease, such as schizophrenia and multiple sclerosis, in populations across the world. Research at Liverpool, however, has shown that within the Chinese population there are a high proportion of healthy people that exhibit a pattern of eye movements previously thought to be rare in the absence of injury or disease. Findings, published in the journal Experimental Brain Research, suggest that this pattern may not be as effective as a signal of altered brain function, in every global community, as originally thought.

Working in China and in Britain, the team tested fast eye movements, called saccades. Participants in the study were asked to respond to spots of light with their eyes as they appeared suddenly to the right or left of their line of sight. The reaction time of the eye movements was the key measure that differentiated between Chinese and non-Chinese groups.

Dr Paul Knox, from the Institute of Ageing and Chronic Disease, explains: “In a person from any country in the world we would expect the reaction time of fast eye movements to be approximately a fifth of a second. Very rarely we find some people with eye movement reaction times that are much shorter than this, at around a tenth of a second. This, however, is usually assumed to be a sign of an underlying problem that makes it difficult to keep the eyes pointing where you would like for a long enough period.

“In our study, as we expected, 97% of British people had the common fifth of a second delay, and only 3% had the much faster response. In our Chinese group, however, 30% had the faster, less common response. Our participants were healthy, with normal vision, and yet the eye movement pattern previously thought to be rare, was relatively common in Chinese people.

“There could be a number of explanations for this and further investigation is needed to fully understand why populations differ. It could be that culture – where we grow up, the education, work and social activities we are exposed to – influence these particular biological responses even though our physical make-up is the same.

“The other possibility is that there are basic differences in brain structure and function that produce the kind of behaviour we identified. Maps of the brain were developed many years ago and were largely based on European populations. This became the blueprint for brain structure, but there could be differences between various populations.”

Scientists are now investigating eye movement in Chinese people born and living in Britain compared to Chinese populations born in China but now living in Britain. The study aims to further understanding into the cultural effects on eye movement behaviour.

The research is funded by the Royal Society and the National Natural Science Foundation of China.

Source:
Samantha Martin

University of Liverpool

pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the presentation of new data from the completed 36-month FAME™ Study of ILUVIEN for the treatment of Diabetic Macular Edema (DME) at the 2011 ARVO Annual Meeting. The new data, presented by Dr. Andrew N. Antoszyk, analyzed the subgroup of patients who had been diagnosed with DME for three or more years at entry of the FAME Study (which comprises over 50% of patients in the Study). ILUVIEN is licensed by pSivida to Alimera Sciences, Inc. Alimera reported that it plans to submit this new subgroup data to the FDA in support of its pending New Drug Application.

In the data reported for this subgroup at 36 months in Trial A, 31.8% of patients treated with ILUVIEN experienced an improvement in best corrected visual acuity (BCVA) of 15 or more letters from baseline compared with 13.6% of those in the control group (p=0.010), for a net benefit of ILUVIEN versus control of 18.2%. In Trial B, 36.4% of ILUVIEN patients in this subgroup experienced improvement of 15 or more letters compared to 13.2% of control patients (p= 0.004), for a net benefit of ILUVIEN versus control of 23.2%. On a combined basis for both Trials A and B, at three years the net benefit of ILUVIEN compared to control reported for patients in the subgroup was 20.6%, more than double that seen for the full patient population (9.8%).

In the subgroup, peak efficacy was seen at month 30, with 33.6% of ILUVIEN treated patients in Trial A gaining 15 or more letters in BCVA compared to 10.2 % of control (p < 0.001) and 42.4% of ILUVIEN treated patients in Trial B gaining 15 or more letters in BCVA Trial B compared to 11.3% of control (p< 0.001). Consistent with the full patient population in the FAME Study, approximately 75% of the patients in this subgroup treated with ILUVIEN were reported to have received only one ILUVIEN insert over the 36 month study. There was no statistically significant difference in BCVA improvement in the subgroup of patients with less than three years’ duration of DME at entry compared to control. Safety data for patients within the subgroup of patients with DME diagnosis of at least 3 years’ duration were also reported. Generally, subgroup patients receiving ILUVIEN experienced fewer pressure-related side effects compared to control than was reported for the full patient population in the trial. By the end of the 36-month study, intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 14.8% of the subgroup patients (5.4% of control), as contrasted with 18.4% of the full patient population (4.3% of control). By month 36, 5.3% of the subgroup patients had undergone an incisional surgical procedure to reduce elevated IOP (0.0% of control), compared to 4.8% in the full patient population (0.5% of control). During the study, 35.9% of the subgroup (15.2% of control) had received IOP-lowering medication compared to 38.4% of the full patient population (14.1% of control). Data on cataracts for the subgroup were also reported. At the entry of the trial, many patients had already received cataract surgery. Of the remaining patients with a natural lens, the incidence of cataracts was 86.0% at month 36 for the subgroup (51.5% for control), with 85.1% undergoing a cataract operation (36.4% for control). By comparison, in the phakic full study patient population, the incidence of cataracts was 81.7% at month 36 (50.4% for control), with 74.9% undergoing a cataract operation (27.3% for control). The FAME Study consisted of two three-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN® in the treatment of DME. The 956 patients in the trials were randomized to receive either high dose ILUVIEN, low dose ILUVIEN or control treatment. The primary endpoint for efficacy in the trials was the difference in the percentage of patients whose BCVA improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at month 24 between the treatment and control groups. As previously reported, the pre-specified 24-month primary endpoint for the FAME Study was met for the low dose ILUVIEN in both Trial A and Trial B. Based on these data, Alimera submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 29, 2010 for approval of the low dose ILUVIEN. Therefore, only the low dose data is presented and discussed in this press release. As previously reported, Alimera received a Complete Response Letter from the FDA in December 2010, requesting analyses of safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted in the NDA, to further assess the relative benefits and risks of ILUVIEN. In February 2011, Alimera reported results from the full patient population at month 36 of the FAME Study. Paul Ashton, President and Chief Executive Officer, said, “We are very pleased with the efficacy and safety results through month 36 in patients with chronic DME. This subgroup comprised a majority of patients in the FAME Study. We look forward to Alimera’s filing of this data with the FDA in connection with the NDA for ILUVIEN.” Data for the subgroup analyses was gathered from 536 patients who had been diagnosed with DME for three years or more and 416 patients who had been diagnosed with DME for less than three years. About the FAME Study Alimera conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN with two doses of the corticosteroid fluocinolone acetonide (FAc), a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in September 2010 with the final patient visit at the three-year data point. About DME DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well. About ILUVIEN® ILUVIEN is an investigational, extended release intravitreal insert for the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc. ILUVIEN is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound. Source:
pSivida Corp.

A team of researchers from the University of Granada [ugr.es], in collaboration with the University of Murcia, has developed a visual aid device which significantly improves the vision of sight impaired patients; especially those suffering from pathologies with a slow progression that can eventually lead to blindness (such as Macular Degeneration, cataracts, etc.). This platform, called SERBA (in Spanish, Reconfigurable Electric-optical System for Low Vision), is the first visual aid unit which is very useful in all circumstances and for all tasks, independently of the degree of impairment of the patient. Up to now, in the majority of cases, people with impaired vision had to acquire various different devices to meet all their needs.

The main contribution of this project undertaken by M?? Dolores Pelaez Coca and led by professors Fernando Vargas Mart?�n and Eduardo Ros Vidal, all from the University of Granada is the implementation of a new optoelectronic platform (based on a reconfigurable device known as FPGA) which is easily reprogrammed so that it can be used in different circumstances. This device will help patients, among other things, to improve their vision when driving.

This platform, as the creator of the research explains, is based on the design of a real-time video processing system able to store several image processing algorithms. “Thanks to the use of a FPGA it is a very flexible device which can be adapted to the user’s needs and to the evolution of their disease”. Eight patients suffering from Retinitis Pigmentosa (a visual impairment that reduces the field of vision) took part in the device’s assessment, as well as six others with different pathologies that generate a loss of sharpness of vision.

Updating through the Internet

The program is stored in the internal memory of the prototype board and the selection of the dump algorithm in the FPGA is carried out automatically. In this way, the images are shown in a transparent viewfinder, similar to those used in the army. With this system, there is no need to purchase a new platform so as to adapt it to the changes that are produced in the disease’s development; it is enough simply to update the programmes recorded in the device’s memory. This update can be carried out through the Internet, so the support and travelling expenses can be reduced considerably.

So as to prove the viability of the project, researchers from the University of Granada have developed three different image processing computer programmes: edge enhancement, three different kinds of digital zoom lens and the implementation of an augmented view scheme system.

The main advantage of SERBA is that it is easily reconfigured and that it also offers, in researchers’ own words, a “technological convergence”, as it includes light low-cost cameras, real time image processing and transparent portable viewfinders.

A driving video game

This visual aid system designed by scientists from the University of Granada [ugr.es] and the University of Murcia has contributed to the creation of bioptical telescopes, anamorphic systems and inverted telescopes that magnify the patient’s visibility as it implements zoom lens effects, edge enhancement and edge multiplexing to expand the field of vision. Moreover, a driving video game (with some enlargements in some areas of the image) has been developed to simulate the visual aids previously mentioned. The selection of the area to magnify is supplied by a Head Tracker that the subject carries in a cap.

Several companies have already shown their interest in commercialising this system created by the University of Granada, as SERBA is improving the sharpness of vision and contrast sensitivity, apart from offering an effective field of vision for very restricted visual fields and facilitating the subject’s mobility.

UNIVERSITY OF GRANADA COMMUNICATIONS DEPARTMENT
Secretariado de Comunicaci??n Universidad de Granada
Hospital Real Cuesta del Hospicio s/n
ugr.es