Month: June 2014

Two pediatric eye surgeons at Washington University School of Medicine in St. Louis expressed alarm over what they label a “21st century snake oil” scam.

Recent newspaper stories including several from Missouri — have reported parents flying their children to main land China for umbilical cord stem cell (CSC) infusions. The cost of these treatments, paid for entirely out-of-pocket by the parents, can be $50,000 or more. CSCs are extracted from the umbilical cords of Chinese mothers and their newborns and injected into the fluid around the spinal cord of the American children. The parents are led to believe by Chinese doctors that these CSCs are an effective treatment for optic nerve hypoplasia (ONH), a disease causing partial blindness at birth.

ONH is growth failure of one or both optic nerves during the first trimesters of pregnancy. The nerve is the “cable” connecting the eye to the brain and each nerve should have one million fibers; in ONH the number of fibers ranges from 200,000-800,000. ONH, which affects about 1 in 5,000 newborns, is not hereditary and the exact cause is unknown.

Lawrence Tychsen, M.D., and Gregg Lueder, M.D., professors of ophthalmology and visual sciences at Washington University School of Medicine and pediatric ophthalmologists at St Louis Children’s Hospital, diagnose and treat dozens of children each year with ONH. They are concerned that the CSC reports will mislead many parents of children with ONH, who may bankrupt savings, go deeply into debt or organize fundraisers to pay for sham treatment.

Although some parents claim improvement in their child’s vision after returning from China, Tychsen and Lueder caution that no objective visual gains after CSC treatment have been demonstrated in any child with ONH. They can measure visual improvements objectively in infants and toddlers using non-invasive nerve and brain imaging and electronic measures of visual brain activity. They add that one would expect “a powerful placebo effect after these purported treatments.

The temptation to believe vision had improved, after the expenditure of so much time and money, would be difficult to resist.” Aside from grave ethical concerns, they say that the injections could be dangerous, introducing infection or toxic matter into the brain fluids.

Tychsen, who is also a neurobiologist studying visual brain development in infant monkeys, listed a number of reasons to disbelieve reports of improvement. First, CSCs placed in human spinal fluid would not be transported into the fibers of the optic nerve. Second, CSCs have never been shown to transform into optic fibers, even in fish or rodent experiments. In a monkey or human, the task would be “several orders of magnitude more complex,” Tychsen said. Third, to improve vision, 100,000 or so fibers would need to grow, not just a few, and each of the fibers would need to connect precisely in the brain.

“CSCs are used legitimately throughout the United States to treat blood diseases (such as leukemia) when the donor and recipient are genetically matched,” Tychsen said. “But CSCs from an unrelated person are rejected and destroyed. Even if an unmatched CSC survived, found its way inside the optic nerve and transformed itself into a new fiber, the fiber would need to find the correct connection among more than 500,000 connections in the visual brain.

Such a series of events would be so improbable as to qualify as miraculous, the equivalent of a chimpanzee typing the five acts of King Lear at one sitting,” Tychsen said. He said he believes that experiments by neuroscientists devoted to the discovery of nerve growth molecules may hold the best hope for future cures.

Lueder pointed out that parents of ONH children should not despair.

“Many babies born with ONH will have some improvement as they mature, because they learn to exploit more effectively the optic fibers that remain,” he said. Children with ONH can also achieve some improvements with surgery for eye crossing and nystagmus (roving movements of the eyes). He added that many ONH children function reasonably well in school using enlarged print, magnifiers and other aids for the visually impaired.

Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

Washington University in St. Louis
One Brookings Dr., Campus Box 1070
St. Louis, MO 63130
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The American Academy of Ophthalmology’s (Academy) Task Force on Haiti Recovery, in cooperation with the Pan-American Association of Ophthalmology (PAAO), is coordinating donation and distribution of ophthalmic equipment and supplies to Haitian ophthalmologists, including several exam lanes (complete sets of the equipment needed to provide a thorough eye exam)*, thousands of doses of pharmaceuticals, surgical supplies, educational materials and much more. View a complete list of all in-kind donations as a result of the efforts of the task force.

This outpouring of support by the international ophthalmic community came in response to the Academy’s initial campaign to provide five portable eye units to Haiti. In total, the campaign solicited in-kind donations valued at over one half million U.S. dollars.

To facilitate donations, the task force worked closely with PAAO and the Bascom Palmer Eye Institute. Haitian ophthalmic leadership-the Haitian Society of Ophthalmology and the University of Haiti Eye Hospital-is collaborating with the Academy on distribution of the eye units and other materials.

“As a result of the earthquake, many of our colleagues were left without the equipment and structure they needed to provide quality patient care,” said David W. Parke II, MD, the Academy’s executive vice president and CEO.” I am proud of the ophthalmic community’s overwhelming response in this time of great need and of the Academy’s role in the collaborative effort to rebuild Haiti’s eye care system.”

Haitian ophthalmologists told of practices destroyed, shortages of supplies and equipment, and increased demand for ophthalmic care. The Academy’s Task Force on Haiti Recovery was created to respond to the urgent and ongoing need for quality eye care in Haiti and to coordinate ophthalmic recovery efforts.

“We are extremely satisfied with our partnership and look forward to continued productivity and collaboration throughout our joint efforts yet to come,” said Frantz Large, MD, president of the Haitian Society of Ophthalmology.

“The Academy’s efforts have been consistent since the disaster,” said Michael W. Brennan, MD, chair of the Task Force on the Haiti Recovery. “From the immediate response and evaluation of needs to the subsequent facilitation and solicitation of supplies, we are proud to have been able to aid our colleagues in this trying time.”

In addition to the portable eye unit campaign, the Foundation of the Academy established a Disaster Relief Fund to provide ophthalmic resources and facilitate much-needed patient care. All of the funds collected will be used for Haitian recovery efforts.

*A complete lane includes an exam chair; a slit lamp, to magnify the eye; a tonometer, to test the pressure inside of the eye; a projector, to check vision; a phoropter, to determine vision correction prescriptions; and an indirect ophthalmoscope, for examination of the retina at the back of the eye.

Source:
American Academy of Ophthalmology

In a first-of-its-kind safety research study, University of Florida researchers have injected an anti-inflammatory compound into the eye of a person with a sight-robbing disease.

The procedure was performed last month to test the safety and effectiveness of a synthetic peptide – a small protein fragment – in procedures involving the human eye.

“All patients with macular degeneration have good peripheral, or side, vision, but it’s their central vision that’s affected in both the dry and the wet forms of the disease,” said Shalesh Kaushal, M.D., Ph.D., an assistant professor of ophthalmology and director of the vitreoretinal service in the UF department of ophthalmology.

Macular degeneration affects about 9 million Americans, according to the National Eye Institute. About 15 percent of those people have the wet form of the disease, in which leaky blood vessels crop up like weeds beneath the macula, a part of the retina responsible for central vision.

Doctors can inject the eyes with drugs to stem the abnormal growth of blood vessels, but that approach benefits only the 15 percent of patients afflicted with the wet version, leaving the vast majority of people with macular degeneration in the dark.

These therapies only manage the symptoms, according to Cedric Francois, M.D., Ph.D., the president and CEO of Potentia Pharmaceuticals Inc., the company that designed the anti-inflammatory compound and is funding the safety trial at UF.

“In about 15 percent of people with macular degeneration, you get bleeding in the back of the eye. The drugs that are on the market can stop that bleeding from occurring but they don’t treat the cause of the disease,” said Francois. “The problem was that until recently, no one knew how the illness worked.”

That changed two years ago, when a series of reports in the journal Science shed light on the underlying mechanisms of macular degeneration. The reports revealed a link between the chronic inflammation and tissue damage that accompany both forms of the disease and a genetic defect in the complement system, a series of enzymes that defend the body against pathogens by stimulating a potent inflammatory response.

“Complement is a set of proteins that are often triggered in inflammatory diseases, including the eye in particular,” Kaushal said. “There are now multiple reports that these complement proteins may be overstimulated in wet macular degeneration.”

Those reports allowed scientists to begin tackling the disease from the roots up.

“What’s become clear in the biology of this disease is that there are multiple facets to the disease process. The inflammatory component may be central to the development of age-related macular degeneration because it affects the survival of visual cells and also promotes new blood vessel growth,” Kaushal said.

With that in mind, researchers from Potentia Pharmaceuticals Inc. set out to develop an existing family of complement inhibitors called Compstatin for use in the human eye. In animal studies, complement inhibitors have been shown to prevent the inappropriate inflammatory response that accompanies both the wet and dry forms of macular degeneration.

Compstatin and its derivative, POT-4, are the first molecules of their kind to prevent overactivation of the complement pathway.

“Compstatin is a unique complement inhibitor,” said John Lambris, Ph.D., the University of Pennsylvania professor of pathology and laboratory medicine who initially discovered the peptide over 12 years ago. “POT-4 is a much more active version of the original compound.”

Now, teams from Florida, New Hampshire, Minnesota and Arizona are evaluating the safety of POT-4 in humans with the wet form of macular degeneration. The first and third subjects received injections of the peptide at UF in November and December. The second subject was treated in New Hampshire in November.

The UF scientists continue to monitor the subjects closely to gather important information about the safety profile of POT-4. After a safety committee reviews data from the first round of participants, an additional 12 subjects will participate in the study.

“Any peptide or protein that you inject into the eye has the potential for kicking up inflammation,” Kaushal said, noting that because POT-4 is injected locally into the eye in the same method used to deliver existing treatments for macular degeneration, the possibilities for widespread side effects are limited.

Scientists are beginning to explore the role of complement in rheumatoid arthritis, psoriasis, asthma and Alzheimer’s disease.

“There are many human diseases related to complement,” Kaushal said. “That whole area of research has just blossomed over the last four or five years.”

Recent UF Health Science Center news releases are available at news.health.ufl.edu/.

A guide to UF health and medical experts is available here.

The University of Florida Health Science Center – the most comprehensive academic health center in the Southeast – is dedicated to high-quality programs of education, research, patient care and public service. The Health Science Center encompasses the colleges of Dentistry, Public Health and Health Professions, Medicine, Nursing, Pharmacy and Veterinary Medicine, as well as the Veterinary Medical Teaching Hospital and an academic campus in Jacksonville offering graduate education programs in dentistry, medicine, nursing and pharmacy. Patient care activities, under the banner UF&Shands, are provided through teaching hospitals and a network of clinics in Gainesville and Jacksonville. The Health Science Center also has a statewide presence through satellite medical, dental and nursing clinics staffed by UF health professionals; and affiliations with community-based health-care facilities stretching from Hialeah and Miami to the Florida Panhandle.

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Glaucoma researcher Miguel Coca-Prados, professor of ophthalmology and visual sciences at Yale School of Medicine, recently completed a professorship at Pfizer’s Groton Laboratories as the 2006 Yale-Pfizer Global Discovery Visiting Professor.

Now in its third year, the Visiting Professor Program is a 12-week sabbatical for an outstanding Yale faculty member to consult and do research on site at Pfizer Global Research and Development in Groton/New London. Not only does this program strengthen the working institutional relationship between Yale and Pfizer, it provides Yale faculty an insider understanding of the pharmaceutical industry and generates new collaborations for future research.

Coca-Prados studies the how mutations causing glaucoma alter the normal function of the cells in the eye where it is expressed. His laboratory has identified a number of genes relevant to the cell and molecular function of ciliary epithelium, a tissue that regulates intraocular pressure. In glaucoma, an abnormal elevation of intraocular pressure is one of the strongest known risk factors for developing the disease, which affects about 67 million people worldwide. His work is creating a better understanding of the molecular and cellular changes of glaucoma and producing new strategies to revert the abnormal function of the protein myocilin when it is mutated.

During his stay at Pfizer, Coca-Prados delivered four lectures and had a chance to visit many different Pfizer sites, including the Clinical Research Unit in New Haven, the Research Technology Center in Cambridge, Mass., the Proteomics Center in Ann Arbor, Mich. and the Ophthalmology Research laboratories in La Jolla, Calif.

“One of my goals was to learn innovative techniques in proteomics and systems biology,” said Coca-Prados, who sought to develop long-term collaborations for his research. “As a result of our new collaboration with Pfizer researchers at the Ophthalmology area in LaJolla we will begin studies on predictable biomarkers and targets in glaucoma.”

The Yale-Pfizer Global Discovery Visiting Professor Program was developed and sponsored by the Discovery Laboratories at Pfizer Global Research and Development, the Women’s Leadership Network at Pfizer and the Office for Women in Medicine at Yale.

“Over the past three years, our scientists have brought three distinct areas of research to the collaboration. Each has had a unique first-hand experience in the challenges of the pharmaceutical industry and each has returned to their students and fellows with new insights for their research,” said Merle Waxman, associate dean and director of the Office for Women in Medicine at Yale School of Medicine. “We are delighted with the ongoing success of the Pfizer Visiting Professor Program partnership.”

“I was impressed with how efficiently the labs are run in Groton,” Coca-Prados said. “I look forward to incorporating my newfound knowledge into my future research. I encourage other Yale investigators to take advantage of this opportunity.”

“The 2006 Visiting Professor Program expanded the breadth and depth of interactions between our Yale visiting professor and the global Pfizer organization,” said Karen Houseknecht, associate research fellow and past-president of the Women’s Leadership Network at Pfizer.

“Dr. Coca-Prados not only had the opportunity to build relationships with Pfizer scientists at five of our U.S. research/clinical sites, but he also interfaced with leaders throughout the organization including clinicians, sales and marketing colleagues,” Houseknecht added. “This unique program gave him the opportunity to learn about, and give his input on, the myriad complexities and challenges of discovering, developing and marketing new and innovative medicines for patients. We are excited about the new relationships being built between Pfizer and Yale scientists participating in this program, and look forward to future collaborations.”

Yale News Releases are available via the World Wide Web at yale.edu/opa

For further information please go to:
Yale University

Prof. Michael Belkin, a professor at Tel Aviv University’s Goldschleger Eye Research Institute, makes sure his grandchildren wear sunglasses, even as babies. He advises all parents to do the same.

He ought to know. Belkin has been researching the eye for over 30 years, and is one of the foremost professors in this field. In his latest research – a collaboration with researchers from Hebrew University and the Technion-Israel Institute of Technology led by Dr. Yossi Mandel, a senior ophthalmologist in the Israel Defense Forces Medical Corp – Belkin showed that babies born during the summer months of June and July have a 24% greater chance of becoming severely shortsighted than those born between December and January.

The reason: early-life exposure to natural light. According to Belkin, the body has a mechanism that causes the eyeball to lengthen, causing shortsightedness, when exposed to prolonged illumination. Hence, the more light a newborn is exposed to after birth, the more the eyeball lengthens and the worse the myopia will be.

The mechanism is associated with melatonin, a pigment secreted by the pineal gland, which sets our body’s internal clock and permits it to participate in ‘Circadian rhythms’, though scientists are not sure exactly how it operates.

Myopia – where distant objects appear blurred – is a very common condition worldwide. In Israel 17.3 percent of the population entering the military (which is compulsory), suffer from shortsightedness. By the time they leave three years later, the occurrence has risen to 25%.

In some countries, like Japan and China, 50% of children starting school are shortsighted, rising to 80% at the end of high school.

While there are many factors involved in short-sightedness, including genes, intelligence (yes, people in bottle top glasses are often smarter than their peers), and years of study (80% of students at religious yeshivot are short-sighted, while 60-70% of professors at Tel Aviv University suffer the condition), the new study shows that in severely myopic individuals – where the numbers rise above five or six – the season of birth can also have a major impact.

The first indications of this came when Dr. Uvall Cohen, one of Belkin’s students, carried out a study of chickens. Cohen discovered that he could control the degree of shortsightedness in the chickens by the controlling the amount of light the chicks experienced in their first weeks of life.

“This gave us the idea that sunlight might affect the growth of the eye,” says Belkin.

The next step was to examine people. With the HU and Technion researchers, Belkin and Mandel began studying data on young people aged between 16-23 admitted to the IDF.

The scientists took data on almost 300,000 people, making it one of the world’s largest epidemiological surveys in any field, and retroactively correlated the incidence of myopia with their month of birth.

They took into account birth complications, weather, infectious agents, socioeconomic status and education. They also registered the eyesight of siblings born during other months.

The results, published this month in clinical eye journal, Ophthalmology , were clear. A child born in the winter or fall, will have better long-range eyesight throughout its lifetime and less chance of requiring thick corrective glasses than those born in the summer.

Belkin points out the graph in his report, which visibly indicates the rise in severe myopia in children born during the summer months, when there is an average of 4.2 more hours more sunlight per day than in winter. “You don’t need to look any further than that,” he says. “This was the largest study of its kind, and the results were conclusive. It’s got nothing to do with the stars, or your horoscope, it’s to do with the season.”

He also believes that this research is likely applicable to babies born anywhere in the world.

Belkin is a leading figure in ophthalmology research worldwide. He was one of the founders and first director of the Goldschleger Institute, established more than 25 years ago at the Sheva Medical Center in Tel Aviv, and is Incumbent to the Fox Chair of Ophthalmology.

His main area of research is lasers and their applications for curing eye disease such as glaucoma and age-related macular degeneration – the leading causes of blindness. He also recently co-authored a report with Dr. Zohar Habot-Wilner, also of the Goldschleger Eye Institute, which showed a link between obesity and the occurrence and development of all four of the major eye diseases that cause blindness – cataracts, glaucoma, age-related macular degeneration, and diabetic retinopathy. Belkin expects to publish a new report on stem cells and lasers in the coming months.

Belkin is also a board member of a number of companies creating promising treatments, including Proneuron, stem cell therapy company TheraVitae and El-Vision, which is developing a diagnostic device for the eye. One of his ideas, for a microscopic surgical implant to treat medically uncontrolled glaucoma, is now being commercialized by the company Optonol.

“Slight myopia is not really significant, but severe myopia, where numbers rise above five or six is already a disease that can lead to visual problems that cannot be solved by glasses alone,” says Belkin. “The eye in childhood is much clearer than when we are older so it’s vital that our children start to wear sunglasses from birth onwards, particularly those in hot, sunny countries. Severe myopia, cataracts and retinal degeneration are partly due to UV light from the sun. It’s cumulative and it adds to the severity. I have little doubt that they can be partially corrected by using sunglasses in childhood.”

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Can we always see what is in front of us? According to Dr. Tony Ro, a Professor of Psychology and Cognitive Neuroscience at The City College of New York (CCNY), the answer is “no.” New research published in The Journal of Neuroscience by Professor Ro and colleagues from the University of Illinois demonstrates that the brain cannot detect images when brainwave activity is in a trough.

“We may have our eyes open, but we sometimes miss seeing things,” Professor Ro said. “When the brain is in a state of readiness, you see; when it is not, you don’t see.”

Brainwave activity has peaks and troughs that can occur around 10 times a second, he explained. In their research, Professor Ro and his colleagues demonstrated how the phase of the brainwave or alpha wave can reliably predict visual detection.

Subjects were shown a faint image of a dot on a computer screen and asked to indicate whether they saw the image by pushing a button. Subsequently, the dot was masked making it more difficult to see. “We tried to see whether there was variability in people’s ability to see the image,” he said. “When we presented the dots with masks sometimes people saw it and sometimes they didn’t.”

The research has potential applications in improving safety. For example, automobile accidents often occur because drivers miss seeing something, even if for a split second, he explained.

“With brain sensors we might be able to know when people will actually miss seeing something. By being able to predict whether or not someone will see something, we should be able to implement better ways of delivering information to people to ensure that they will detect it. This might then enhance safety, reduce errors, and prevent mishaps that frequently occur because people fail to see something that is right in front of them.”

Professor Ro said future research will investigate what occurs when images are flashed by a strobe light at intervals to match these brainwave frequencies.

Notes:

About The City College of New York

Since 1847 The City College of New York has provided low-cost, high-quality education for New Yorkers in a wide variety of disciplines. Over 15,000 students pursue undergraduate and graduate degrees in the College of Liberal Arts and Sciences; The School of Architecture; The School of Education; The Grove School of Engineering, and The Sophie Davis School of Biomedical Education.

Source:
Ellis Simon

City College of New York

Neurobiologists funded by the Office of Naval Research (ONR) have discovered a potential cure for degenerative vision diseases leading to terminal blindness.

The solution, however, may be rooted in an unconventional therapeutic approach.

Scientists at the Friedrich Miescher Institute for Biomedical Research in Basel, Switzerland, are manipulating the proteins that cause blindness in mice. The scientists have successfully restored vision in the light-sensing cells of the retina.

Dr. Thomas McKenna, program officer for ONR’s Neural Computation Program, said this research has significant future implications.

“In the course of their study, these researchers discovered an approach to restore vision in blind mice with congenital macular degeneration,” McKenna said. “This technology shows great promise for the partial restoration of vision for blind patients.”

This initiative, supported by ONR Global’s Naval International Cooperative Opportunities in Science and Technology Program (NICOP), studies retinitis pigmentosa, the incurable genetic eye disease, which causes more than 2 million worldwide cases of tunnel vision and night blindness. If left untreated, the disease can lead to complete blindness as the color-sensing cells in the retina slowly degenerate.

Dr. Clay Stewart, technical director, ONR Global, explained the importance of the NICOP program for providing a platform for innovative international basic research that could ultimately have a profound impact on naval activities.

“The NICOP grants are of a seedling nature and are aimed at maturing foreign science and technology projects to the point that they can be picked up by ONR or other [Naval Research Enterprise] organizations,” Stewart said. “In the case at hand, this world-class cognitive research team has developed science that has the potential of being useful in restoration of visual acuity in subjects with impaired vision, such as Sailors or Marines who have sustained head injuries in combat.”

McKenna, a recipient of the 2009 Delores M. Etter Top Scientists and Engineers of the Year award, said additional studies are needed before making the treatment available to visually challenged populations. Next, the team plans to explore the duration of therapeutic effects and whether the gene therapy could have applications for other eye diseases.

Source:
Peter Vietti
Office of Naval Research

Cells isolated from the eye that many scientists believed were retinal stem cells are, in fact, normal adult cells, investigators at St. Jude Children’s Research Hospital have found. If retinal stem cells could be obtained, they might provide the basis for treatments to restore sight to millions of people with blindness caused by retinal degeneration. Stem cells are immature cells capable of producing large numbers of adult cells, such as retinal cells. Researchers believe that stem cells offer the promise of regenerating tissue in organs such as the eye, brain and heart, damaged by trauma or disease.

The new findings suggest that research on cell therapies to restore blindness should not concentrate on these eye cells previously believed to be retinal stem cells. More promising, the scientists said, is research aimed at re-engineering stem cells to develop into the light-sensitive photoreceptor cells that are lost as a result of retinal degeneration. Such studies could lead to implantation of such engineered photoreceptor cells into the eye to restore sight.

Led by Michael Dyer, Ph.D., the researchers published their findings March 30, 2009, in the online early edition of the Proceedings of the National Academy of Sciences. Dyer is a member of the St. Jude Department of Developmental Neurobiology.

In studies reported in 2000, scientists proposed that the layer of ciliary epithelial cells lining the inside of the eye, contains retinal stem cells because when grown in culture dishes these cells formed tiny spheres of about a thousand cells, said Dyer, the paper’s senior author. These spheres, in turn, could be cultured to give rise to more spheres, reminiscent of the self-renewing capability of stem cells. Also, the cultured sphere cells showed activation of genes characteristic of adult eye cells.

“The first clue that these cells were not stem cells was that they were pigmented,” Dyer said. “Neural stem cells, in general, and retinal progenitor cells, in particular, are not pigmented. Nevertheless, the previous finding was met with a tremendous amount of enthusiasm because of the promise of introducing these cells into the eye to regenerate photoreceptors lost to blindness.”

In their studies, Dyer and his colleagues analyzed the sphere-forming cells in detail to determine whether they were really retinal stem cells. Painstaking microscopy studies of each cell in the spheres revealed all were pigmented and had features of ciliary epithelial cells. The researchers also compared the structure of the sphere-forming cells with those of confirmed stem cells and other immature cells in the developing retina called progenitor cells. That comparison revealed fundamental differences between the sphere-forming cells and established stem or progenitor cells.

The researchers also found that simply culturing the sphere-forming cells in the same growth medium as is used for stem cells caused them to activate genes characteristic of stem cells, yet remain adult ciliary epithelial cells.

Dyer said that a particularly promising alternative is the possibility of taking samples of adult cells – such as fibroblasts that form connective tissue – from a patient with retinal degeneration and exposing them to genetic cues that induce them to revert to stem cells. Those induced pluripotent stem cells could then be manipulated to develop into light-sensing photoreceptor cells that could then be transplanted into the patient’s eyes to restore vision.

“This approach would solve many problems of developing cell-based therapy for blindness,” Dyer said. “First, these cells are immortal, so they can be grown indefinitely to produce large amounts of cells for treatment. And secondly, they would be immunologically matched to the patient, so there would be no danger of rejection. And thanks to some excellent research during the past 15 years, we know a lot about how to reprogram such stem cells to make them into photoreceptors.”

Other authors of this paper are Samantha Cicero, Sharon Frase, Samuel Connell, Lionel Chow, Suzanne Baker and Brian Sorrentino (St. Jude); Dianna Johnson (University of Tennessee Health Sciences Center); and Steve Reyntjens (FEI Helios Nanolab, Netherlands).

This research was supported in part by the National Institutes of Health, Cancer Center Support from the National Cancer Institute, American Cancer Society, Research to Prevent Blindness, Pearle Vision Foundation, International Retinal Research Foundation 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 fundraising organization. For more information, please visit stjude.

St. Jude Children’s Research Hospital
stjude

As flooding continues to expand
across much of the Midwest, the American Optometric Association (AOA)
reminds contact lens wearers to closely follow hygiene and compliance
instructions issued by their eye doctor. Higher temperatures combined with
standing water can mean an increase in the number of cases of eye
infections. In particular, the Acanthamoeba parasite and other
micro-organisms can contaminate the lens case and infect the cornea. Water
contaminated with Acanthamoeba can come from lakes, rivers, and swimming
pools. Acanthamoeba infections are rare, but can be dangerous and threaten
a person’s vision if not properly detected and treated.

Doctors of optometry recommend that lens wearers take the following
precautions to avoid exposing their eyes to Acanthamoeba or other
flood-related eye infections:

— Remove contact lenses prior to entering flood waters or before other
water activities including swimming

— Contact lens wearers who regularly sleep in contact lenses as
prescribed should refrain from doing so if exposed to water

— Always sterilize contact lens cases and wash and dry hands prior to
handling lenses

“Contact lenses are among the safest forms of vision correction,” said
Dr. Louise Sclafani, chair of the AOA’s Contact Lens and Cornea Section.
“Patients can and should take an active role in protecting themselves from
eye infections by carefully following their optometrist’s instructions
regarding care of contact lenses.”

According to the AOA, proper lens hygiene and compliance includes using
fresh cleaning or disinfecting solution each time lenses are cleaned and
stored. Additionally, most solutions are approved for use without rubbing;
however, optometrists are recommending that patients rub their lenses to
enhance cleaning for additional safety.

A Food and Drug Administration (FDA) advisory panel met last week to
address contact lens safety and compliance issues related to past
Acanthamoeba and Fusarium keratitis incidences among lens wearers. The FDA
regulates contact lenses and lens care products as medical devices, a
classification that requires the lens and product makers to obtain the
agency’s approval before marketing and sales. The AOA is working with the
FDA to take a closer look at contact lens safety and compliance, improve
product testing procedures and enhance labeling of eye care products. The
panel heard testimony from AOA representatives Dr. William J. Benjamin and
Dr. Louise Sclafani, among other eye care experts, to discuss stricter
standards for contact lens solutions. The FDA is considering changes in
current no-rub policies, the pre-market testing of products, and changes in
labeling of products.

“We are supportive of the FDA in making changes to help protect the
sight of Americans,” said Dr. William J. Benjamin, speaking on behalf of
the AOA’s Commission on Ophthalmic Standards” “We support the FDA in
requiring that products be tested under more realistic conditions, when
feasible, and in situations where lens wearers are not compliant with a
doctor’s instructions. We also support the agency’s review of labeling
requirements for care products.”

Since more than 80 percent of all contact lens wearers go to an
optometrist for their eye care (according to the Contact Lens Institute),
AOA doctors of optometry have taken an active role in educating patients
and working with federal health officials to improve lens wear and care
instructions.

“We are also asking the FDA to require an expiration date on bottles of
solution. Currently, the FDA does not require a mandatory discard date
after opening,” said Dr. Sclafani. “The only current requirement is that
the solution must have a preservative or be packaged to reduce
contamination. This has been confusing for both patients and doctors.”

Additionally, AOA leaders are asking the FDA to include Acanthamoeba on
their list of parasites that they test for in products. Currently, the
Acanthamoeba parasite is not included as part of the FDA’s standard testing
process.

According to the AOA, there are measures contact lens wearers can and
should take to reduce their risk of infection.

Recommendations for Contact Lens Wearers from the American Optometric Association

1. Always wash your hands before handling contact lenses.

2. Carefully and regularly clean contact lenses, as directed by your
optometrist. Rub the contact lenses with fingers and rinse thoroughly
before soaking lenses overnight in sufficient multi-purpose solution to
completely cover the lens.

3. Store lenses in the proper lens storage case and replace the case at
a minimum of every three months. Clean the case after each use, and keep
it open and dry between cleanings.

4. Use only products recommended by your optometrist to clean and
disinfect your lenses. Saline solution and rewetting drops are not designed
to disinfect lenses.

5. Only fresh solution should be used to clean and store contact
lenses. Never re-use old solution. Contact lens solution must be changed
according to the manufacturer’s recommendations, even if the lenses are not
used daily.

6. Always follow the recommended contact lens replacement schedule
prescribed by your optometrist.

7. Remove contact lenses before swimming or entering a hot tub.

8. See your optometrist for your regularly scheduled contact lens and
eye examination.

Contact lens wearers who are at higher risk for Acanthamoeba include
those in areas with heavy flooding or lens wearers exposed to water while
wearing contacts. It is important that contact lens users consult their
optometrist immediately if they notice changes in their eyes or vision.

Key Symptoms of Acanthamoeba include:

— A red, (frequently) painful eye infection-especially if the patient
reports that it is not improving with treatment.

— Keratitis symptoms such as foreign body sensation, tearing, light
sensitivity, and blurred vision.

— Red, irritated eyes lasting for an unusually long period of time
after removal of contact lenses.

About the American Optometric Association (AOA):

The American Optometric Association represents more than 34,000 doctors
of optometry, optometry students and paraoptometric assistants and
technicians. Optometrists provide more than two-thirds of all primary eye
care in the United States and serve patients in nearly 6,500 communities
across the country. In 3,500 of those communities they are the only eye
doctors.

American Optometric Association doctors of optometry are highly
qualified, trained doctors on the frontline of eye and vision care who
examine, diagnose, treat and manage diseases and disorders of the eye. In
addition to providing eye and vision care, optometrists play a major role
in a patient’s overall health and well-being by detecting systemic diseases
such as diabetes and hypertension.

Prior to optometry school, optometrists undergo three to four years of
undergraduate study that typically culminates in a bachelor’s degree with
extensive, required coursework in areas such as advanced health, science
and mathematics. Optometry school consists of four years of post-graduate,
doctoral study concentrating on both the eye and systemic health. In
addition to their formal training, doctors of optometry must undergo annual
continuing education to stay current on the latest standards of care. For
more information, visit aoa.

American Optometric Association
aoa

Oraya Therapeutics, Inc. today announced that it has completed enrollment of its INTREPID clinical trial in Europe. The study is the first sham-controlled, double-masked trial to evaluate the effectiveness and safety of radiation therapy in conjunction with standard of care anti-VEGF injections for the treatment of wet age-related macular degeneration (AMD). Oraya’s proprietary IRay™ stereotactic radiotherapy system employs externally delivered robotically controlled low-energy X-rays. The IRay treatment is a one-time non-surgical procedure which may significantly reduce or eliminate the need for subsequent anti-VEGF injections, while maintaining or improving vision outcomes in treated patients. Total procedure time typically takes less than 15 minutes. One year efficacy results of INTREPID will be available in the second quarter of 2012.

Enrollment in the INTREPID trial was completed on April 15 with 226 subjects. One third of those subjects received a sham exposure, with the remainder receiving a radiation dose of either 16 or 24 Gray (Gy). This multi-national study includes sites in Austria, Czech Republic, Germany, Italy and the United Kingdom. The number of clinical investigators and the number of prospective enrollees increased rapidly over the later stages of trial enrollment.

“We were very pleased with the high level of interest in participating in this trial on the part of both prospective patients and investigators and their clinical staffs,” said Tariq Aslam, M.D., Chief Investigator and Consultant Ophthalmologist at the Manchester Royal Eye Hospital. “In fact, we had more sites and more prospective enrollees than we could accommodate. That suggests that wet AMD patients and their ophthalmologists are looking forward to the possibility of having a one-time therapy shown to maintain visual acuity while reducing or avoiding the need for chronic drug therapy with anti-VEGF injections.”

“We at Oraya recognize that we were unable to accommodate all the patients who expressed a desire to participate in the INTREPID trial,” said Jim Taylor, CEO of Oraya Therapeutics, “and we want them to know that we have plans to conduct a larger study in the UK and elsewhere beginning later this year. That will afford the opportunity to many more patients to participate in a clinical trial of this promising therapy. We also want patients and their families to know that we understand the cost and lifestyle burdens that the currently available drug therapy places on them, and we will continue to evaluate our IRay radiation therapy to assess its safety and efficacy in maintaining visual acuity while reducing or eliminating the need for regular injections.” Information on future studies will be available on the company’s web site.

Wet AMD is a major cause of vision loss in the elderly. The disease arises from a combination of factors that initiate inflammatory processes which lead to neovascularization, fluid leakage, scar formation, and/or atrophy of the retina. Oraya’s device delivers a highly-localized dose of X-ray radiation to the macula using a proprietary positioning system, targeting algorithm, and special contact lens for eye stabilization and tracking. Radiation has been demonstrated to inhibit multiple inflammatory pathways, as well as to have a direct deterring effect on neovascular capillaries and scar formation, and thus holds considerable promise for the treatment of wet AMD.

The IRay is a CE marked medical device. In the United States, it is limited by U.S. Federal law to investigational use.

Source:

Oraya Therapeutics