A Dry AMD Treatment?; Some Long-Term Diabetics Escape PDR

At the American Academy of Ophthalmology (AAO) – Middle East-Africa Council of Ophthalmology (MEACO) Joint Meeting yesterday, Oct. 17, researchers reported progress on two top eye disease challenges: treating advanced “dry” age-related macular degeneration, and preventing blindness in people with diabetes. The Joint Meeting is in session October 16 through 19 at McCormick Place, Chicago. The AAO-MEACO meeting is the world’s largest, most comprehensive ophthalmic education conference.

Proven Arthritis Drug Shows Promise versus Dry AMD

While ophthalmologists can turn to several medications for patients with vision-threatening “wet” age-related macular degeneration (AMD), there are no effective treatments for advanced “dry” AMD, the more common form. Today a research group led by Jason S. Slakter, MD, New York University School of Medicine, reports on a phase-two clinical trial of fenretinide, a synthetic derivative of vitamin A. Risk of developing wet AMD decreased almost two-fold in dry AMD patients who took the medication. Geographic atrophy (GA) lesion growth was also reduced in the fenretinide group. This reduced growth correlated with lowered blood levels of the biomarker retinol binding protein (RBP) – an indication that fenretinide was working. Patients whose RBP decreased 60 percent or more also had the most significant reductions in lesion growth. GA lesions degrade the area of the eye called the retinal pigment epithelium (RPE), which can result in significant vision loss.

Advanced AMD, in either wet or dry form, can destroy the detailed, central vision we need to recognize faces, read, drive, and enjoy daily life. It is a major cause of vision loss in the United States. In the advanced wet form abnormal new blood vessels develop under the retina, then bleed or leak fluid and form scars. Advanced dry AMD sometimes abruptly converts to the wet form.

Fenretinide works on three key AMD disease mechanisms: it has strong anti-inflammatory properties, inhibits abnormal blood vessel growth (angiogenesis) and reduces vitamin-A derived toxins such as A2E and lipofuscin. These toxins accumulate in the RPE and interfere with its ability to nourish light-receptor cells in the retina.

“Evidence from our study and others points to fenretinide’s potential to treat and prevent diseases of the retina,” Dr. Slakter said.

This randomized controlled trial included 246 patients at 30 sites around the United States. Tests showed that patients’ visual acuity and other markers of eye health were not adversely affected by fenretinide. Side effects, including delayed ability to adapt to dark conditions, were minor and reversible when the medication was stopped. Years of use of fenretinide to treat cancers, rheumatoid arthritis, and other diseases have shown it to be safe and well tolerated. ReVision Therapeutics, the company supporting the continued clinical development of fenretinide, is planning a Phase 3 clinical trial to begin in 2011.

Financial disclosures: This research was supported by a grant to the Digital Angiography Reading Center; Dr. Slakter served as a consultant to Sirion Therapeutics.

Clues to Retinopathy from Survivors of 50+ Years of Diabetes

Doctors assume that the longer a person has diabetes, the more likely he or she is to develop serious eye disease and, if untreated, become blind. But a new study of patients who have had type 1 diabetes for at least 50 years tells a different story. Many of these patients appear to be protected against proliferative diabetic retinopathy (PDR), and the majority of them escape vision loss despite extremely long-duration diabetes, according to Jennifer Sun, MD, Beetham Eye Institute at Joslin Diabetes Center, a Harvard School of Medicine affiliate.

With one exception, development of PDR occurred within the first two decades in these Joslin patients (in 96 of 97 patients). If PDR did not develop during that period, then retinopathy progressed slowly and in some cases stopped altogether. PDR development was associated with higher blood pressure, but not with glycemic (blood sugar) control. This confirmed an earlier, larger study’s surprising finding that neither glycemic control nor duration of diabetes correlated with the severity or presence of diabetic retinopathy (DR) in patients who successfully survived 50 or more years with type 1diabetes. Decreased blood levels of the protein tyrosine phosphatase SHP-1 was also associated with protection from development of any DR, and Dr. Sun recommends further study of SHP-1 to learn whether it might be a target for treatment.

“There is no doubt that lack of glycemic control is a major factor in the development of eye complications for patients with shorter-duration diabetes. But our data from this unique group of individuals who have survived extremely long-duration diabetes may help identify other factors that protect against retinopathy complications,” said Dr. Sun. “These findings also suggest that protective mechanisms are activated very early in diabetes.”

Source:
Mary Wade
American Academy of Ophthalmology

Disease Leads To Vision Loss More Often In African Americans

African American people are more likely to lose vision as a result of idiopathic intracranial hypertension, or increased pressure in the brain, according to a study published in the March 11, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.

“The racial difference does not appear to be based on differences in diagnosis, treatment or access to care,” said study author Beau Bruce, MD, of Emory University School of Medicine in Atlanta, GA. “The disease affects African Americans more aggressively. Doctors may need to monitor their African American patients more closely and take steps to prevent vision loss earlier than with other patients.”

The cause of idiopathic intracranial hypertension is not known. Symptoms include headache, ringing in the ears, and vision problems such as blurriness and double vision. It is most common in young, obese women.

For the study, researchers reviewed the medical records of all patients at Emory University with intracranial hypertension over a 17-year period. Of the 450 people, 197 were African American. There were 246 whites, five Hispanic people and two Asian people in the study.

The African American patients were 3.5 times more likely to have severe vision loss in at least one eye, and they were nearly five times as likely to become legally blind than the non-African American patients.

Bruce noted that the African Americans in the study had other risk factors, such as higher body mass index and higher frequency of low blood iron, and higher pressures around the brain than non-African American participants, and that these factors could partially account for the increased risk of vision loss.

The study was supported in part by grants from Research to Prevent Blindness, Inc., and the National Institutes of Health.

The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer’s disease, epilepsy, Parkinson’s disease, and multiple sclerosis.

American Academy of Neurology

Glaucoma Research Foundation 2010 Benefit Celebrating The Scientists

“Celebrating the Scientists” is the theme of this year’s Glaucoma Research Foundation Annual Benefit and Celebration. The benefit takes place on Wednesday, January 27, 2010 at the legendary Palace Hotel in San Francisco.

As the Glaucoma Research Foundation’s annual fundraiser, the benefit focuses on recent results from GRF-funded research and the donors who make it possible. Governor Arnold Schwarzenegger is the Honorary California Chair and Mayor Gavin Newsom is the Honorary San Francisco Chair. The event Co-Chairs are Nobuko Saito Cleary and Gary Cleary, PharmD, PhD.

At the benefit, the Glaucoma Research Foundation’s highest honor, the Catalyst Award, will be presented to Jeffrey B. Kindler, Chief Executive Officer and Chairman of the Board of Pfizer Inc. The award recognizes outstanding accomplishments in research and education in support of those affected by glaucoma.

“The Annual Benefit draws attention to the looming global epidemic of blindness due to glaucoma and the importance of innovative research to find a cure before it’s too late,” said Thomas M. Brunner, President and CEO of the Glaucoma Research Foundation.

At this year’s benefit, the principal investigators in the “Catalyst for a Cure” consortium funded by the Glaucoma Research Foundation will update attendees on their latest results. Their research has led to a better understanding of glaucoma as a neurodegenerative disease and could open the door to treatments that actually treat the underlying disease rather than current treatments that lower intraocular pressure as a means of reducing disease progression.

Catalyst for a Cure principal investigators include: David Calkins PhD, Vanderbilt University; Philip Horner PhD, University of Washington; Nicholas Marsh-Armstrong PhD, Johns Hopkins University; and Monica Vetter PhD, University of Utah. Major funding for Catalyst for a Cure is provided by a grant from the Melza M. and Frank Theodore Barr Foundation through the Glaucoma Research Foundation.

“Nationally, there continues to be a marked shortage of funding for the innovative research needed to find a cure for this leading cause of blindness,” said Mr. Brunner. “We simply must continue to raise the funds necessary to keep up the momentum of this productive research, as well as to provide invaluable educational resources needed to help patients and raise public awareness.”

Source
Glaucoma Research Foundation

American Academy Of Ophthalmology Joint Meeting Marked By Strong Turnout And Rich Scientific Program

Strong turnout and a robust scientific program marked the largest and most comprehensive ophthalmic educational meeting in the world, the American Academy of Ophthalmology’s (Academy) 2008 Joint Meeting in conjunction with the European Society of Ophthalmology (SOE), held in Atlanta November 8 to November 11. Preliminary figures for attendance at the meeting were approximately 22,000. Among the offerings featured at the meeting were 277 instruction courses, 79 “Breakfast with the Expert” roundtables, 95 skills transfer courses and more than 100 hours of free scientific sessions. Preliminary figures for attendance at the Subspecialty Day events November 7 and 8 were also strong, totaling more than 6,200.

“This meeting was a huge success by all measures. It was a great opportunity for members to meet with colleagues and to learn about the latest advances in ophthalmic care and research,” said H. Dunbar Hoskins Jr., MD, executive vice president of the Academy.

The keynote address for the meeting was delivered by Harvey V. Fineberg, MD, PhD, president of the Institute of Medicine. In his address, Seeing the Future of Health Care, Dr. Fineberg laid out the paradox that is health care in America today. “It’s the most expensive system in the world, but it fails to live up to expectations,” he said. At the same time, America is facing a demographic transition that will significantly increase the demand for care, particularly ophthalmic care. “Ophthalmology is in the crosshairs of this demographic transition and the demand for services and cost of health care in the United States,” Dr. Fineberg said. “We are facing challenging times, but ophthalmology has an opportunity not only to play a part in the solution but to be an exemplar.” The key, he said, is to “relentlessly focus on increasing the value of what we do for patients-a combination of improving performance and outcomes and decreasing costs. Getting more for every dollar spent.” Listen to Dr. Fineberg’s address.

“Dr. Fineberg’s remarks underscore the challenge that the Academy and its members face in the coming years with the projected explosion in age-related eye diseases,” said Dr. Hoskins. “That’s why the Academy has undertaken an effort that we call Eye on Efficiency, to help practices meet those demands in the future.”

The opening session on November 9 also included the presentation of the 2008 Laureate Recognition Award, the Academy’s highest honor, to Alan C. Bird, MD., one of the world’s experts on the treatment of retinal vascular disease and genetic and degenerative retinal disorders.

Scientific Program Highlights and Press Briefings

Scientific Program Highlights: The scientific sessions provided a chance to hear directly from ophthalmic researchers on a wide range of leading-edge investigations. Presentations of particular note included:

Plasma Interleukin 6 as a Potential Biomarker of Age-related Macular Degeneration (AMD). Janice C. Law, MD, and her colleagues at the Vanderbilt Eye Institute, identified Interleukin 6 (IL-6) as a good candidate for further study as a potential biomarker for AMD. Read more about this study.

Corneal Collagen Crosslinking: Treatment Results in Keratoconus Patient. Co-investigators Mohan Rajan, MD, and Sujatha Mohan, MD, of the Rajan Eye Care Hospital, India, found that the corneal collagen crosslinking technique used to treat 60 eyes of patients with keratoconus resulted in positive corneal changes and improved vision and contact lens tolerance. Read more about this study.

Damage to Optic Nerve in Glaucoma Patients May Indicate Significant Carotid Artery Narrowing.Mostafa Elgohary, MD, of Essex County and Broomfield Hospitals, United Kingdom and his colleagues found an association between internal carotid artery narrowing and the development of glaucoma or glaucoma-like damage to the optic nerve in a significant percentage of patients in their study. Read more about this study.

Could Religious Beliefs Affect Compliance with Ocular Treatment? Researchers led by Nishant Kumar, MBBS, of the University Hospital, Liverpool, United Kingdom, conducted this first study of patient compliance with self-administered eye drop treatments in relation to fasting by surveying people who practice the world’s major faiths. Read more about this study.

Contamination of Contact Lens Storage Cases of Refractive Surgery Candidates. Assaf Kratz, MD, and Tova Lifshitz, MD, of Soroka University Medical Center in Israel and their colleagues found significant levels of pathogens that can cause keratitis in contact lens storage cases of candidates for refractive surgery. Read more about this study.

Refractive Surgical Practices in Persons with Human Immunodeficiency Virus (HIV) Positivity. Ahmad A. Aref, MD, Pennsylvania State Hershey Eye Center, Pennsylvania State University College of Medicine, and his colleagues investigated current care practices and opinions among refractive surgeons regarding LASIK, intraocular lenses after cataract removal, and similar procedures in people who are HIV-positive or have AIDS. Read more about this study.

Anti-VEGF for Severe Retinopathy of Prematurity. Alay S. Banker, MD, and his colleagues, Banker’s Retina Clinic and Laser Centre, Gujarat, India, evaluated antivascular endothelial growth factor (Anti-VEGF) therapy in 21 babies who had or were at high risk for retinopathy of prematurity (ROP) and found rapid, effective treatment provided results that avoided the complications and risks of other ROP treatments and was safer to provide to medically fragile babies. Read more about this study.

Media Briefings: Three briefings for the media provided overviews of advances in eye-related research, patient care, and health policy in 2008. Audio of the briefings, along with the presenters’ slides, are available in the Academy Newsroom. The topics covered were:

Advances in Pediatric Ophthalmology, with panelists Michael X. Repka, MD. R. Michael Siatkowski, MD, and Jonathan M. Holmes, MD.

Advances in Glaucoma Care and Research, with panelistsAndrew G. Iwach, MD, and Ruth D. Williams, MD.

Health Care Reform in the New Administration, presented by William Rich, MD, the Medical Director of Health Policy for the Academy.

2008 Year in Review: Updates on Key Issues in the News (LASIK, Age-Related Macular Degeneration Treatments, and Contact Lens Care), with panelists Richard L. Abbott, MD, George A. Williams, MD, and Thomas L. Steinemann, MD.

About the American Academy of Ophthalmology

AAO is the world’s largest association of eye physicians and surgeons-Eye M.D.s-with more than 27,000 members worldwide. Eye health care is provided by the three “O’s” . opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. For more information, visit the Academy’s Web site at aao.

American Academy of Ophthalmology

Role For Macrophages In Age-related Macular Degeneration

Macrophages–cells involved in the immune response–may have a crucial role in age-related macular degeneration (AMD). Rajendra Apte and colleagues from the Washington University School of Medicine used a mouse model of choroidal neovascularization–new vessel formation, (CNV) –which is an important part of AMD, to show that preventing macrophage entry into the eye encouraged new vessel formation, whereas direct injection of macrophages significantly inhibited this process.

Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 y of age in at least three continents. CNV is the process by which abnormal blood vessels develop underneath the retina. CNV develops in 10% of patients with AMD but accounts for up to 90% of the blindness from AMD. This study suggests that regulators of macrophages may be a possible therapeutic target in AMD.

Citation: Apte RS, Richter J, Herndon J, Ferguson TA (2006) Macrophages inhibit neovascularization in a murine model of age-related macular degeneration. PLoS Med 3(8): e310.

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PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE
VERSIONS OF YOUR REPORT: dx.doi/10.1371/journal.pmed.0030310

CONTACT:

Rajenda Apte
Washington University School of Medicine
Ophthalmology
660 South Euclid Avenue
Box 8096
St.Louis, MO 63110 United States of America

aptevision.wustl.edu

About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit plosmedicine/

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Contact: Andrew Hyde

Public Library of Science

What The Brain Saw

The moment we open our eyes, we perceive the world with apparent ease. But the question of how neurons in the retina encode what we “see” has been a tricky one. A key obstacle to understanding how our brain functions is that its components – neurons – respond in highly nonlinear ways to complex stimuli, making stimulus-response relationships extremely difficult to discern.

Now a team of physicists at the Salk Institute for Biological Studies has developed a general mathematical framework that makes optimal use of limited measurements, bringing them a step closer to deciphering the “language of the brain.” The approach, described in the current issue of the Public Library of Science, Computational Biology, reveals for the first time that only information about pairs of temporal stimulus patterns is relayed to the brain.

“We were surprised to find that higher-order stimulus combinations were not encoded, because they are so prevalent in our natural environment,” says the study’s leader Tatyana Sharpee, Ph.D., an assistant professor in the Computational Neurobiology Laboratory and holder of the Helen McLorraine Developmental Chair in Neurobiology. “Humans are quite sensitive to changes in higher-order combinations of spatial patterns. We found it not to be the case for temporal patterns. This highlights a fundamental difference in the spatial and temporal aspects of visual encoding.”

The human face is a perfect example of a higher-order combination of spatial patterns. All components – eyes, nose, mouth – have very specific spatial relationships with each other, and not even Picasso, in his Cubist period, could throw the rules completely overboard.

Our eyes take in the visual environment and transmit information about individual components, such as color, position, shape, motion and brightness to the brain. Individual neurons in the retina get excited by certain features and respond with an electrical signal, or spike, that is passed on to visual centers in the brain, where information sent by neurons with different preferences is assembled and processed.

For simple sensory events – like turning on a light, for example – the brightness correlates well with the spike probability in a luminance-sensitive cell in the retina. “However, over the last decade or so, it has become apparent that neurons actually encode information about several features at the same time,” says graduate student and first author Jeffrey D. Fitzgerald.
“Up to this point, most of the work has been focused on identifying the features the cell responds to,” he says. “The question of what kind of information about these features the cell is encoding had been ignored. The direct measurements of stimulus-response relationships often yielded weird shapes, and people didn’t have a mathematical framework for analyzing it.”

To overcome those limitations, Fitzgerald and colleagues developed a so-called minimal model of the nonlinear relationships of information processing systems by maximizing a quantity that is referred to as noise entropy. The latter describes the uncertainty about a neuron’s probability to spike in response to a stimulus.

When Fitzgerald applied this approach to recordings of visual neurons probed with flickering movies, which co-author Lawrence Sincich and Jonathan Horton at the University of California, San Francisco, had made, he discovered that on average, first-order correlations accounted for 78 percent of the encoded information, while second-order correlations accounted for more than 92 percent. Thus, the brain received very little information about correlations that were higher than second order.

“Biological systems across all scales, from molecules to ecosystems, can all be considered information processors that detect important events in their environment and transform them into actionable information,” says Sharpee. “We therefore hope that this way of ‘focusing’ the data by identifying maximally informative, critical stimulus-response relationships will be useful in other areas of systems biology.”

The work was funded in part by the National Institutes of Health, the Searle Scholar Program, The Alfred P. Sloan Fellowship, the W.M. Keck Research Excellence Award and the Ray Thomas Edwards Career Development Award in Biomedical Sciences.

Source:
Gina Kirchweger

Salk Institute

World’s Largest Ocular Research Center To Improve Quality Of Life For Blind And Visually Impaired

Real-time biomedical studies of factors leading to vision impairment are now possible through the world’s largest ocular research center at Lions Eye Institute for Transplant & Research. As the first research center in the world to be directly combined with an eye bank, the Ocular Research Center provides a repository of healthy and diseased ocular tissue for researchers from academic institutions, government organizations and the pharmaceutical industry.

For the first time, researchers can study the complete picture of health through tissue, medical history and family information, which will improve the understanding of underlying health factors leading to vision impairment and blindness. These studies will drive the development of new diagnostic tests and pharmacologic treatments for delaying, stopping and preventing progression of ocular diseases and conditions.

Over the past 30 years, Lions Eye Institute for Transplant & Research has provided 50,000 eyes for research and given the gift of sight through cornea transplantation to more than 30,000 men, women and children worldwide.

“The Ocular Research Center recently established a relationship with Emory University and we look forward to forming relationships with other organizations to accelerate drug innovation, provide timely clinical trials and formalize best practices,” said Jason Woody, Lions Eye Institute for Transplant & Research CEO.

The initial research platforms will explore the leading causes of blindness, macular degeneration and glaucoma, which affect millions of Americans. Macular degeneration is the leading cause of vision loss in the elderly, profoundly affecting their quality of life. Glaucoma, affecting upwards of 3 million Americans, contributes to more than 120,000 new cases of blindness each year and is the leading cause of blindness among African Americans.

A non-profit, charitable organization founded in 1973, the Lions Eye Institute for Transplant & Research improves outcomes and enhances quality of life for people who are blind or visually impaired. The Lions Eye Institute strives to fulfill the Lion’s pledge to Helen Keller “to be the Knights of the blind in the crusade against blindness” through the recovery, evaluation, and distribution of eye tissue for transplantation, research and education. For more information, visit ocularresearch.

Source
Ocular Research Center

Alcon Launches TobraDex(R) ST Suspension

Alcon (NYSE: ACL), the world’s leading eye care company, announced the launch of its new combination anti-inflammatory/anti-infective product, TobraDex® ST suspension in the United States. TobraDex® ST (tobramycin/dexamethasone ophthalmic suspension) 0.3/0.05% is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk for infection exists.

TobraDex® ST suspension was formulated to enhance bioavailability to targeted tissues. This makes TobraDex® ST a good treatment choice for conditions such as acute blepharitis and other inflammatory conditions where an infection may also exist.

“This product was specifically designed to increase retention time on the eye, allowing the drug to calm inflammation and fight bacteria effectively,” said Stuart Raetzman, vice president, Global Marketing and area president for the United States. “Clinical studies indicated that 10 minutes after dosing, concentrations of TobraDex® ST remained on the ocular surface at levels high enough to kill 99.9% of ocular bacteria.”

TobraDex® ST suspension is designed with stable suspension properties that prevent settling, thereby ensuring the desired amount of dexamethasone delivery. In addition, TobraDex® ST is formulated with low viscosity in the bottle allowing for easier dispensing. These two factors contribute to making this an ideal treatment for eye conditions where both infection and inflammation exist, like acute blepharitis or bacterial conjunctivitis.

“This product’s superior staying power offers an advantage for patients to receive a treatment that provides fast and effective relief from uncomfortable symptoms of inflammatory ocular conditions, such as acute blepharitis,” said Stephen Lane, M.D., clinical professor at the University of Minnesota. “This represents an excellent clinical option when treating blepharitis that is quite common.”

About TobraDex® STSuspension

TobraDex® ST suspension is a topical antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions where superficial bacterial ocular infection or a risk of infection exists. The most common side effects experienced with the use of TobraDex® ST include: eye pain, eyelid itching, eyelid swelling, eye redness and possible increases in pressure in the eye leading to glaucoma.

About Blepharitis

Blepharitis is a common disorder that occurs in two forms – anterior and posterior. Blepharitis is an inflammatory condition of the eyelids and may be associated with a low-grade bacterial infection or a generalized skin condition. Common symptoms can include irritation, burning, tearing, foreign body sensation, crusty debris (in the lashes, in the corner of the eyes or on the lids), dryness and red eyelid margins.

Caution Concerning Forward-Looking Statements. This press release may contain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.Any forward-looking statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

Source: Alcon, Inc

Advanced Cell Technology Files IND With FDA For First Human Clinical Trial Using Embryonic Stem Cells To Treat Eye Disease

Advanced Cell Technology, Inc. (OTCBB:ACTC) announced that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). Among the most common causes of untreatable blindness in the world are degenerative diseases of the retina. As many as 10 million people in the United States have photoreceptor degenerative disease. While most of these patients have Age-Related Macular Degeneration (AMD), a smaller number of patients have Stargardt’s, an Orphan disease and one of the most common forms of juvenile macular blindness. The treatment for eye disease uses stem cells to re-create a type of cell in the retina that supports the photoreceptors needed for vision. These cells, called retinal pigment epithelium (RPE), are often the first to die off in SMD and AMD, which in turn leads to loss of vision.

While there is currently no treatment for SMD, several years ago ACT and its collaborators found that human embryonic stem cells could be a source of RPE cells. Subsequent studies found that the cells could restore vision in animal models of macular degeneration. In the Royal College of Surgeon (RCS) rat model, implantation of RPE cells resulted in 100% improvement in visual performance over untreated controls without any adverse effects. The cells survived for more than 220 days and sustained extensive photoreceptor rescue. Functional rescue was also achieved in the ‘Stargardt’s’ mouse with near-normal functional measurements recorded at more than 70 days.

“It has been over a decade since human embryonic stem cells were first discovered,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer. “The field desperately needs a big clinical success. After years of research and political debate, we’re finally on the verge of showing the potential clinical value of embryonic stem cell research. Our research clearly shows that stem cell-derived retinal cells can rescue visual function in animals that otherwise would have gone blind. We are hopeful that the cells will be similarly efficacious in patients.”

The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation to advanced patients with SMD. A total of twelve patients will be enrolled into the study at three clinical sites, including the Casey Eye Institute in Portland, Oregon (headed by Dr. Peter Francis of the Oregon Health & Sciences University); the University of Massachusetts Memorial Medical Center, Worcester, Massachusetts (headed by Dr. Shalesh Kaushal, Chair of the Department of Ophthalmology); and the UMDNJ – New Jersey Medical School, Newark, New Jersey (headed by Dr. Marco Zarbin, Chair, Institute of Ophthalmology and Visual Science). “It is an honor for us to be working with ophthalmology researchers of such high caliber,” said Edmund V. Mickunas, Advanced Cell’s Vice President of Regulatory Affairs. “They have been instrumental as collaborators on the clinical trial design and their input has been invaluable.”

“The filing of this IND places Advanced Cell Technology in position to help lead the industry in validating the stem cell platform,” said William M. Caldwell IV, Advanced Cell’s Chairman and CEO. “Over the past year, we have taken important steps to advance our RPE program while overcoming significant financial challenges. Advanced Cell today is uniquely positioned within the regenerative medicine industry; as it has the technology, a renown scientific and development team and access to capital to become one of the first companies to make the use of an embryonic stem cell derived therapy a reality in treating a major unmet medical need.”

Source
Advanced Cell Technology, Inc.

Why Precision-Tinted Lenses Reduce Headaches For Migraine Sufferers

For the first time, researchers have shown why precision-tinted lenses reduce headaches for migraine sufferers, a finding that could help improve treatment options for patients battling the debilitating ailment.

Jie Huang of Michigan State University’s Department of Radiology used functional magnetic resonance imaging, or fMRI, to reveal how precision-tinted lenses normalize brain activity in patients with migraine headaches, preventing such attacks.

Huang’s research appears in the current edition of the journal Cephalalgia, published by SAGE.

While tinted lenses are increasingly used for migraine sufferers, until now the science behind the effects was unclear. The team led by Huang showed how colored glasses – tuned specifically to each migraine sufferer – work by normalizing the activity in the brain’s visual cortex, which is responsible for processing visual information and is located in the back of the brain.

Past research has revealed specific, abnormal brain activity, known as hyper-activation, when migraine sufferers saw intense patterns. The precision-tinted lenses considerably reduce the effect.

As part of the study, researchers focused on specific visual stimuli known to trigger migraines. These patterns, high contrast stripes or gratings, can give the illusion of shape, color and movement, not only triggering migraines but also causing seizures in some photosensitive epileptics.

Participants first were prescribed tinted lenses with an intuitive colorimeter, a device used to illuminate text with different colored lights, creating for each test participant an optimal color of light that led to the greatest comfort by reducing distortion.

Tinted lenses with this optimal color were created and given to each test subject, along with two other sets of tinted lenses without the optimal color. In addition, each patient was paired with a migraine-free control subject, who also was tested with that patient’s three sets of lenses.

Once in the fMRI machine, the subjects were exposed to a range of striped patterns while their brain images were acquired. Then the researchers analyzed the effect of the tinted lenses on the activation of the different visual areas of the brain.

Specifically, the tinted lenses decreased hyper-activation for migraine sufferers in visual area V2 of the visual cortex of the brain.

Although patients reported some relief (a 40 percent improvement) using the control lenses, the precision-tinted lenses had a significant effect (70 percent improvement) when viewing the stressful stripes.

“The specific characteristics of activation we recorded could provide a potential biomarker for identifying those migraine patients suffering visual cortical hyper-activation,” he said. “This biomarker could prove useful not only for further evaluation of tinted lenses but also for studying the effectiveness of drugs to prevent migraine headaches.”

Huang worked with colleagues from the University of Michigan and the University of Essex in England. The article can be found free for a limited time here.

Source:
Jason Cody

Michigan State University