Month: March 2013

For Stephen Sacks, what started out as a routine basketball game his senior year of high school turned into a medical emergency. Stephen was a young basketball star who played years of hoops without any injuries. But when he was accidentally elbowed in the eye by a teammate, Stephen ended up with a large laceration on his left eyelid and a close encounter with permanent eye damage.

“After the knock to my eye, all I could see was a black haze,” Stephen recalls. “I was rushed to the emergency room in the middle of the game, where I was told that I might have permanent damage to my left eye.” Fortunately Stephan regained his vision three weeks later, but had to miss his last senior game because of the eye injury. He went on to play college basketball and has vowed to always wear protective eyewear while playing.

April is Sports Eye Safety Awareness Month, and through its EyeSmart™ campaign the American Academy of Ophthalmology reminds the public that 40,000 people suffer from eye injuries related to sports every year. The Academy advocates the need for athletes to wear appropriate, sport-specific protective eyewear properly fitted by an eye care professional. Lenses made from polycarbonate materials provide the highest level of impact protection; they can withstand a ball or other projectile traveling at 90 miles per hour.

“Eye injuries from sports can be devastating, and the only way to prevent them is by wearing protective eyewear” said Monica L. Monica, MD, Ph.D., clinical correspondent for the Academy and Stephan’s doctor. “Most people don’t realize that basketball is one of the leading causes of eye injuries because of elbows and fingers hitting the eye.”

In addition to abrasions of the cornea and bruises of the lids, sports injuries can include retinal detachments and internal bleeding. The most serious risks involve permanent vision loss along with infection. In addition, patients who have sustained eye injuries are at greater risk for developing glaucoma.

Student athletes are not the only ones who can suffer from eye injuries, as seen with Phoenix Suns player Amar?� Stoudemire; he will be out of the game for the rest of the basketball season because of a detached retina. Amare’s injury will require significant time to heal according to his doctor. In a recent statement, Stoudemire said that he will be wearing protective eyewear from here on out.

Many sports create risk for eye injuries; however, protection is available for most sports, including basketball, baseball, hockey, football, lacrosse, fencing, paintball, water polo, golf and others. “Wearing properly fitted protective eyewear will not harm your performance, and it may well save your sight,” says Dr. Monica. Most sporting leagues don’t require children to wear eye protection, so parents should take special care to ensure their children wear eye protection.

Learn about eye injuries, names of Eye M.D.s in your area or ask an Eye M.D. a question by visiting GetEyeSmart. Consumers can submit questions about eye health to an ophthalmologist at geteyesmart/ask/

About the American Academy of Ophthalmology

The American Academy of Ophthalmology 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. To find an Eye M.D. in your area, visit the Academy’s Web site at aao.

Source
American Academy of Ophthalmology

Second Sight® Medical Products, Inc., the leading developer of retinal prostheses for the blind, announced that it will increase patient enrollment for the ArgusTM II Retinal Implant study throughout clinical trials sites within Europe. The three-year feasibility study is currently underway in the United States, Europe and Mexico for people with Retinitis Pigmentosa (RP), a genetic eye disease that causes blindness.

“We are encouraged by the results we have seen in the seventeen individuals that have participated in the study so far,” said Robert Greenberg, MD, PhD, President and CEO of Second Sight. “We are now expanding our trial enrollment in order to strengthen our data, further demonstrate clinically meaningful performance and begin the process of seeking market approval.”

Retinal Prostheses are currently the only devices being studied to provide some sight to subjects blinded from outer retinal degenerations, such as advanced RP. Second Sight conducted its first proof-of-concept clinical study in early 2002 at Doheny Eye Institute at the University of Southern California (USC) in Los Angeles. During that study, six RP volunteers were implanted with the Argus I system and many continue to use it at home for several hours each day.

The Argus II, the latest device being studied in the clinical trial, is the second generation Retinal Prosthesis that consists of a 60-electrode grid that is surgically implanted on the retina. These electrodes transmit information acquired from an external video camera that is mounted on a pair of eyeglasses worn by implanted subjects. The implant has been designed to last a lifetime, but can safely be removed if necessary.

Preliminary results from the Argus II feasibility study were presented last month at the American Society of Retinal Specialists (ASRS) in Hawaii. According to Mark Humayun, MD, PhD, Professor of Ophthalmology at the Doheny Eye Institute at USC, there were no device failures and few serious adverse events occurred in the 17 subjects that have been enrolled in the study for an average of 14 months, the most serious of which resulted in removal of an implant without difficulty or harm to the individual. Additionally, Dr. Greenberg reported on the orientation and mobility performance observed in the first 11 study volunteers. Using Second Sight’s Argus II system, these individuals were frequently able to locate a door up to 20 feet away and walk to the end of a 20 foot line drawn on the floor.

Internationally, three major European centers are participating in the feasibility study, including Service d’Ophtalmologie, H??pital Cantonal Universitaire de Gen??ve in Geneva, Le Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts in Paris, and Moorfields Eye Hospital in London. Second Sight continues to enroll subjects at these centers and may establish additional clinical trial centers in Europe. Furthermore, the company has made additional improvements to the Argus II system that may increase its clinical benefits.

“These first results hold a novel and quite unprecedented promise for blind subjects as well as the physicians and researchers that have the opportunity to participate in this pioneering endeavor,” commented Jose-Alain Sahel, MD, Principal Investigator and Chairman, Department of Ophthalmology, Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, Paris. “We now have a strong incentive for continuing and expanding the efforts in testing this new technology.”

Four leading ophthalmic centers throughout the U.S. have enrolled subjects in the study to date, including Doheny Eye Institute at the University of Southern California (USC) in Los Angeles, CA, Wilmer Eye Institute at Johns Hopkins University in Baltimore, MD, the University of California at San Francisco and the Retina Foundation of the Southwest in Dallas, TX. Second Sight is currently seeking permission from the US Food and Drug Administration to further expand the U.S. trial. The study is also being conducted at Centro de Retina Medica y Quirurgica, SC, Centro Medico Puerta de Hierro, CUCS and Universidad de Guadalajara in Guadalajara, Mexico.

“Retina International and its members in more than 40 countries are excited that this innovative research is now in critical clinical trials and that it is bringing hope to thousands of people with advanced retinal disease,” says Christina Fasser, President of Retina International and CEO of Retina Switzerland. The British Retinitis Pigmentosa Society, Retina France, the F?�d?�ration des Aveugles de France and the Fondation Ophtalmologique Rothschild have been similarly supportive in Europe.

The development of this technology was largely supported by the National Eye Institute (NEI) of the National Institutes of Health (NIH), and the Department of Energy’s Office of Science (DOE) Artificial Retina Project, which is helping to advance the implant’s design and construction.

About Second Sight

Second Sight® Medical Products, Inc., located in Sylmar, Calif., is a privately held company founded in 1998 by Alfred Mann and others with the goal of creating a retinal prosthesis to provide sight to subjects blinded from outer retinal degenerations, such as Retinitis Pigmentosa. Through dedication and innovation, Second Sight’s mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to overcome their disability and achieve greater independence. The company has received extensive U.S. federal support in developing this new technology and is grateful for the forward thinking of the National Institutes of Health/National Eye Institute and the Office of Science at the Department of Energy in supporting significant aspects of this work. For more see 2-sight.

This press release contains forward-looking statements. Second Sight Medical Products wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements, and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, regulatory approvals, reimbursement, and other factors. Second Sight is a registered trademark and Argus is a trademark of Second Sight Medical Products, Inc.

Second Sight® Medical Products, Inc.

If you follow a diet rich in antioxidant vitamins and minerals your risk of developing age related macular degeneration will not be reduced, according to an article published in the British Medical Journal (BMJ).

Age related macular degeneration is the leading cause of partial blindness in elderly people. It happens when the light sensitive cells in the macula break down progressively. The macula is located in the center of the retina at the back of the eye.

A patient with age related macular degeneration will not usually become totally blind – however, he/she will not be able to read, drive or do anything that requires sharp central vision.

The older you get the higher the risk is of developing age related macular degeneration. Smokers and/or obese people are also at higher risk.

It was suggested that vitamins C and E, various types of carotenoids, and zinc may reduce the oxidative damage to the retina. However, the evidence to show that dietary antioxidants can prevent age related macular degeneration is unclear, explained the writers.

Scientists form the Centre for Eye Researcher Australia, University of Melbourne, analyzed the evidence to determine whether dietary antioxidants or dietary supplements might prevent AMD. They looked at 11 studies which included 149,203 people – seven were prospective studies and three were randomized controlled trials. An assortment of common dietary antioxidants was investigated. All the trial participants came from well fed Western populations and were followed up, on average, for nine years.

All the 11 studies factored in for age, sex and smoking in their analyses.

The studies ranged in the types of antioxidants they investigated. However, when the researchers analyzed all the evidence it was clear that vitamins A and E, zinc, lutein, zeaxanthin, ?�- carotene, ??-carotene, ??-cryptoxanthin and lycopene have either a very slight or no effect on primary prevention of early age-related macular degeneration.

None of the three randomized trials found that antioxidant supplements might protect from early age related macular degeneration.

The researchers concluded that there is not enough evidence to support the role of dietary antioxidants, including the use of dietary antioxidant supplements, for the primary prevention of early AMD.

Jennifer Evans, International Centre for Eye Health, in an accompanying editorial, supports these findings. She added that reducing the prevalence of smoking is probably the best that can be done to reduce the risk of AMD.

“Dietary antioxidants and primary prevention of age related macular degeneration: systematic review and meta-analysis”
Elaine W-T Chong, Tien Y Wong, Andreas J Kreis, Julie A Simpson, Robyn H Guymer
BMJ, doi:10.1136/bmj.39350.500428.47 (published 8 October 2007)
— Click here to view abstract online

“Primary prevention of age related macular degeneration”
Jennifer Evans
BMJ, doi:10.1136/bmj.39351.478924.BE (published 8 October 2007)
— Click here to read first 150 words online

Optherion, Inc., a University of Iowa Research Foundation licensee and a company developing products to diagnose and treat age-related macular degeneration (AMD) and other chronic diseases, has announced that it has completed $37 million startup financing.

The company, which has offices and laboratories in New Haven, Conn., will expand into new facilities at the UI’s Oakdale Research Park in Coralville this fall.

Optherion (optherion/) will pursue advanced treatments and diagnostics for AMD and other diseases using core technology licensed from the UI Research Foundation. The company was founded based on scientific discoveries by Gregory Hageman, Ph.D., UI professor of ophthalmology and visual sciences, and Josephine Hoh, Ph.D., at Yale University.

In 2005, Hageman and researchers at Columbia University, the National Institutes of Health, and other institutions reported that two genes involved in controlling inflammation — complement factor H and complement factor B — account for nearly three out of four cases of AMD. Variations in these two genes alter the function of a key pathway in the immune system (called the alternative complement system) which researchers believe leads to AMD.

“Without question, the research discoveries by Dr. Hageman and his collaborators have been major steps in advancing our understanding of this debilitating disease,” said Jean Robillard, UI vice president for medical affairs and dean of the UI Carver College of Medicine. “Now, with this collaboration between the University of Iowa and Optherion becoming a reality, we are uniquely positioned to pursue treatments that address the needs of AMD patients everywhere.”

Meredith Hay, UI vice president for research, emphasized the statewide effort that made Optherion’s expansion in Iowa a reality. “We are delighted that Professor Hageman’s research has contributed to Optherion’s growth and the establishment of research facilities on the University of Iowa Oakdale Research Park,” she said. “The State of Iowa provided essential funding for the laboratories where Optherion and Professor Hageman will optimize their research and development activities, and we are very grateful to the Iowa Legislature, the Governor’s Office and the Board of Regents, State of Iowa, for their support of this very promising project. We eagerly look forward to the day when we welcome Optherion to Iowa and our research park.”

“The establishment of Optherion’s new facility at the University of Iowa Research Park is a major accomplishment,” said Keith Carter, M.D., professor and head of the UI Department of Ophthalmology and Visual Sciences. “This was possible because of the innovative work of Dr. Hageman and his collaborators. The scientific discoveries which led to this venture with Optherion will help the department advance our goal of finding causes and developing treatments for this and other devastating blinding diseases.”

AMD is the most frequent cause of blindness in developed countries, affecting more than 50 million people worldwide and 15 to 20 million people in the United States. People with AMD lose the central part of their vision when the macula, a part of the retina, degenerates. No treatment currently exists for early-stage AMD, and treatment for advanced-stage AMD is limited.

Optherion’s initial focus is to develop disease-modifying therapies to prevent loss of vision in patients with “dry” AMD — the leading cause of blindness in people over age 60 in the developed world — as well as a portfolio of tests that predict, diagnose and monitor progression of the disease. A parallel area of company research is the development of diagnostics and therapeutics for membranoproliferative glomerulonephritis type II (MPGN II), also known as dense deposit disease. This is an end-stage renal disease with an orphan-sized market prevalence, which typically manifests in individuals between 5 and 25 years of age. It is often caused by the same genetic variations underlying AMD.

Among the sources of capital for Optherion’s financing are: Quaker BioVentures, Philadelphia; Domain Associates, Princeton, N.J. and San Diego, Calif.; Johnson & Johnson Development Corp., New Brunswick, N.J.; Purdue Pharmaceutical Products L.P., Stamford, Conn.; Pappas Ventures, Research Triangle Park, N.C.; Biogen Idec New Ventures, Cambridge, Mass.; and GE Healthcare Financial Services, Chicago, Ill.

Colin J. Foster, Optherion’s President and CEO, said “We are gratified by the high quality of investors participating in the Series A financing. We are embarking on a program that exploits a new and exciting area of research with breakthrough potential in areas of high unmet medical need, with a primary focus on preventing blindness among those with dry AMD.” Foster is the former CEO of Bayer Pharmaceuticals in the United States and Region Head for Bayer Pharmaceuticals in North America.

Hageman, the Iowa Entrepreneurial Endowed Professor at the UI, is Optherion’s chief scientific officer and a co-discoverer of the relationship between complement factor H, complement factor B and AMD. In August 2006, he received a five-year, $14.6 million NIH grant to lead an international, multidisciplinary effort to continue research on the genes’ roles in the immune system, with the goal of finding ways to delay or prevent AMD and other related diseases.

“From my perspective, the UI-Optherion partnership is the result of progressive thinking and a ‘can-do’ attitude exhibited by the Iowa Legislature, the Board of Regents, State of Iowa, and the university,” Hageman said. “It’s a great story in terms of economic development, but it’s also a great story in terms of responding to NIH’s commitment to support translational research programs. There is much more work to be done. I sincerely believe that this team has the potential to make a difference in the lives of individuals with this devastating condition.”

The UI Research Foundation and the UI Oakdale Research Park are two of the programs in IOWA Centers for Enterprise, which integrates existing economic development activities at the UI, offers a comprehensive program that promotes economic development and technology transfer, provides assistance to Iowa startups and existing Iowa businesses and communities, and helps the state of Iowa develop a creative, entrepreneurial workforce. IOWA Centers for Enterprise optimizes the flow of university intellectual property into opportunities for licensing, commercialization and business development. For more information, visit enterprise.uiowa.edu/.

STORY SOURCE: University of Iowa Health Science Relations, 5139 Westlawn, Iowa City, Iowa 52242-1178

Source: David Pedersen

University of Iowa

The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer, a virtual training tool which helps to train physicians to perform cataract surgery, has been shown to enhance teaching in cataract surgery when compared to traditional teaching methods. The results of a multi-center study evaluating the program’s effectiveness as a supplement to traditional teaching tools was published in the February issue of Ophthalmology.

Cataract surgery is the most frequently performed surgery in the United States on people over 65 years old, yet it is one of the most difficult surgeries to learn. John Loewenstein, M.D., Mass. Eye and Ear Associate Chief of Ophthalmology for Clinical Affairs and Vice Chair of Education for Ophthalmology, and Bonnie An Henderson, M.D., former director of Mass. Eye and Ear’s Comprehensive Ophthalmology Service, developed the Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer as an interactive computer program to assist ophthalmology residents in learning skills required to perform cataract surgery.

The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer allows ophthalmology residents to experience the decisions required and tasks involved in performing cataract surgery in a virtual environment. Specifically, the program allows the learner or resident to click on actions involved in cataract surgery, view the animated actions on the computer screen and receive feedback as needed. Residents receive the benefit of having access to tips related to the specific surgical task they are performing, or utilizing the option of browsing to learn more about related topics. The program offers a library with resources to the learner, including commentary from experts, surgeons and professors in ophthalmology and video demonstrations. The program also includes video clips of actual surgery.

Important benefits of The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer include allowing learners to practice the cognitive skills involved in cataract surgery and view the consequences of their surgical decision making in a safe, computer simulated environment. In addition, The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer allows residents to practice surgery at any time, without the need of a teacher or instructor being present. Ultimately, these benefits will be passed on to the patient. To take a look at The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer for yourself and view a demonstration, visit htgnaritas/.

To test the effectiveness of The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer program, a prospective, multi-center, single-masked, controlled trial was conducted using medical residents in the ophthalmology departments of seven academic institutions. Residents were randomized into two groups. One group received a video disc of The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer program in addition to traditional teaching in their residency program, while the other group received written teaching materials in addition to traditional teaching. Both groups took online anonymous pretests and posttests, as well as answering satisfaction questionnaires.

Results showed that there were no differences in pretest scores between the two groups. However, the group provided with The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer program scored significantly higher on their posttests. In addition, the mean difference between pretest and posttest scores for The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer group was significantly better than in group that did not use The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer. Residents responding to questionnaires reported using The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer as being “more fun,” as well as reporting that they were more likely to use a program such as The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer again compared with the likelihood of using traditional tools.

“We’re pleased that the findings of this study suggest that The Massachusetts Eye and Ear Infirmary Cataract Surgery Trainer could be an effective supplement to traditional teaching. We hope that this computer simulation tool, when used as a supplement to teach residents the skills involved in cataract surgery, would better prepare residents for their experience in the operating room,” said Dr. Loewenstein.

Source:
Vannessa Carrington
Massachusetts Eye and Ear Infirmary

A new study published in the July issue of Archives of Ophthalmology finds that eye exam frequency among Hispanic patients with diabetes is smaller than the national average for Hispanics. Beatriz Munoz, M.Sc. (Wilmer Eye Institute, Johns Hopkins University, Baltimore) and colleagues also report that diabetic Hispanics are unaware that diabetes is associated with eye disorders.

“The limited use of health care services in minority groups may make
them more susceptible to the complications of uncontrolled diabetes,”
write the authors. “In addition, a substantial proportion of those with
diabetes are unaware of their condition, although already presenting
signs of moderate to severe diabetic retinopathy. The importance of
appropriate and timely care for diabetic retinopathy or macular edema
[swelling in the retina] is paramount, as it is the leading cause of
visual loss among working-age Hispanic individuals.” About 20% of
Hispanic individuals over 40 years old suffer from diabetes and about
50% of these have the eye condition called diabetic retinopathy, which
can lead to blindness.

This study utilized data from interviews of randomly selected Hispanic
individuals without diabetes (349 participants) and with diabetes (204
participants).?�Mu?�oz and colleagues also asked questions about
demographics, health care habits, and specific medical knowledge about
diabetes and diabetic retinopathy.

The researchers found that of the total,?�less than 10%
indicated a preference for reading in English and 50% said that
language was a barrier to health care. Participants knew that diabetes
could lead to a serious eye disease in the following proportions:

18% of non-diabetics with no family history of diabetes
29%?�of non-diabetics with a family history of
diabetes
36%?�of those newly diagnosed with diabetes
52% of those diagnosed with diabetes more than one year
before

Participants reported that they were aware of preventing eye problems
by strictly controlling diabetes in the following proportions:

16% of non-diabetics with no family history of diabetes
28%?�of non-diabetics with a family history of
diabetes
13%?�of those newly diagnosed with diabetes
34% of those diagnosed with diabetes more than one year
before

Participants indicated that they knew of the importance of dilated eye
examinations in the following proportions:

33% of non-diabetics with no family history of diabetes
51%?�of non-diabetics with a family history of
diabetes
31%?�of those newly diagnosed with diabetes
48% of those diagnosed with diabetes more than one year
before

National samples of Hispanics have shown that about 70 to 75% have had
eye examinations in the past year, but only 30% of diabetic Hispanics
have. In addition, about half of Hispanics who have had diabetes for
over a year, and 79% of those diagnosed one year ago, indicated that
they never received a dilated eye exam.

The authors conclude that: “The lack of correct information about
diabetes and diabetic eye disease in this population of Hispanic
individuals should be of great concern. The frequency of dilated eye
examinations among people with diabetes was unacceptable, and places
this population at risk of visual loss. These deficiencies need to be
rectified with a culturally appropriate health education campaign, and
with innovative ways to reduce barriers to health care.”

Knowledge of Diabetic Eye Disease and Vision Care Guidelines
Among Hispanic Individuals in Baltimore With and Without Diabetes
Beatriz Mu?�oz, MSc; Michael O’Leary, MA; Fannie Fonseca-Becker, PhD;
Evelyn Rosario, BS; Isabel Burguess, BS; Marcela Aguilar, MPH; Cynthia
Fickes, BA; Sheila K. West, PhD
Archives of Ophthalmology (2008). 126[7]:
pp. 968
– 974.
Click
Here to View Abstract

: Peter M Crosta

If two people have the same genetic disease, why would one person go blind in childhood but the other later in life or not at all? For a group of genetic diseases so-called ciliary diseases that include Bardet-Biedl syndrome, Meckel-Gruber syndrome, and Joubert syndrome the answer lies in one gene that is already linked to two of these diseases and also seems to increase the risk of progressive blindness in patients with other ciliary diseases. The findings are published online this week at Nature Genetics.

We are limited in our ability to predict how seriously a genetic disease will affect individual people, even when changes in specific genes have been identified and tied to particular diseases, says Nicolas Katsanis, Ph.D., an associate professor of ophthalmology and molecular biology and genetics at the Johns Hopkins School of Medicine McKusick-Nathans Institute of Genetic Medicine. “In the same way that no two people get exactly the same cancer even though they might carry the same genetic alterations, we know little about how one individual’s disease will interact in the context of their other genes.”

One major obstacle to accurately predicting how a disease plays out in individual patients, Katsanis says, is our poor understanding of “second-site” changes in DNA. These so-called modifiers are alterations in other genes that can affect the functions of the genes that contribute directly to a given disease.

“Every disease can be considered complex because of modifiers,” says Katsanis. “And we know very little about modifiers, what they are and how they affect disease progression. In the case of ciliary diseases where there is a risk of retinal degeneration and blindness, we want to be able to use a person’s genetic information to predict whether or not he or she will go blind and how quickly.”

To identify modifiers of ciliary diseases, the team of scientists examined DNA from patients of northern European descent and from their parents and looked for common changes in the RPGRIP1L gene, which already was known to be defective in some but not all ciliary diseases. Although the frequency of any given change in DNA sequence was rare, several changes appeared only in patients with ciliary disease and not in healthy people, while some changes appeared more frequently in patients than in healthy people. One particular change in the RPGRIP1L gene, called A229T, was seen frequently in DNA from patients who had lost some vision but was absent in DNA from patients who had not lost vision.

As individual changes in single genes are difficult to study in people, the team turned to fish to learn how the A229T change in the RPGRIP1L gene affects cells. Like humans, fish also have a gene very similar to RPGRIP1L. In addition, fish are transparent in their early stages of development, which makes it easier to see how individual changes in genes can affect cellular function, structure or development. When the researchers reduced the amount of RPGRIP1L in fish, the animals developed short and stunted body structures and abnormal tails. When normal RPGRIP1L was added back into these same fish, the fish developed more normal body lengths and tails. However, when RPGRIP1L with the A229T change was added back to the fish, they remained short and stunted. So the researchers concluded that the A229T change must prevent RPGRIP1L from working properly.

The team then investigated why the A229T change in RPGRIP1L might lead to retinal degeneration and blindness in people. To do this, they looked for other proteins that interact with the RPGRIP1L protein by fishing the protein out of eye cells and examining what was stuck to it. They found one protein that stuck to RPGRIP1L but did not stick to RPGRIP1L with the A229T change. This protein interaction must be important for retinal function, they concluded, and loss of this interaction may explain how the A229T change in the RPGRIP1L gene increases the risk for retinal degeneration in patients with ciliary diseases caused by other genes.

Ciliary diseases can cause a variety of symptoms in patients, including kidney failure, nervous system defects, extra fingers and toes, and progressive blindness. According to Katsanis, whether a patient goes blind depends on modifiers like A229T. “A229T increases one’s risk 10 percent to go blind,” says Katsanis. “But it’s only one single genetic change of many possible. Now we want to collect all modifier information so we can develop specific drug information and specific treatment regimens.”

This work was funded by the National Eye Institute; the National Institute of Child Health and Development; the National Institute of Diabetes, Digestive and Kidney Disorders; the Intramural Program of National Eye Institute; the Macular Vision Research Foundation; the Foundation for Fighting Blindness; the Foundation for Fighting Blindness Canada; Le Fonds de la recherch?� en sante de Qu?�bec; Research to Prevent Blindness; the Harold Falls Collegiate Professorship; the Midwest Eye Banks and Transplantation Center; the Searle Scholars Program; the UK Medical Research Council; the NIHR Biomedical Research Centre for Ophthalmology; the EU-GENORET Grant; the Howard Hughes Medical Institute; and the Doris Duke Distinguished Clinical Scientist Award.

Authors of this paper are Hemant Khanna, Carlos A. Murga-Zamalloa, Alejandro Estrada, Mohammad I. Othman, Friedhelm Hildebrandt, Edgar A. Otto and Anand Swaroop of the University of Michigan, Ann Arbor; Erica E. Davis, Perciliz L. Tan, Michael A. Beer and Nicholas Katsanis of the Johns Hopkins University School of Medicine; Irma Lopez and Robert K. Koenekoop of McGill University Health Centre, Canada; Anneke I. den Hollander and Marijke N. Zonneveld of the Radboud University Nijmegen Medical Centre, The Netherlands; Naushin Waseem, Christina F. Chakarova, Cecilia Maubaret and Shomi S. Bhattacharya of the Institute of Opthalmology, UCL, United Kingdom; Anna Diaz-Font and Philip L. Beales of University College London, United Kingdom; Ian MacDonald of the National Eye Institute; Donna M. Muzny, David A. Wheeler, Margaret Morgan, Lora R. Lewis, Richard A. Lewis and Richard A. Gibbs of Baylor College of Medicine; Clare V. Logan, Chris F. Inglehearn and Colin A. Johnson of St. James’s University Hospital, United Kingdom; Samuel G. Jacobson of the University of Pennsylvania; Carsten Bergmann of the RWTH University of Aachen, Germany; and Tania Atti?�-Bitach of H??pital Necker-Enfants Malades, France.

Source: Johns Hopkins Medicine

The American Academy of Ophthalmology (Academy) announced that it had received a record number of submissions for the scientific program for the Academy’s 2009 Joint Meeting with the Pan-American Association of Ophthalmology (PAAO). The Joint Meeting will be held at the Moscone Center in San Francisco Oct. 24 to 27.

“The volume of submissions for this year’s Joint Meeting is a sign of the high level of interest among our members,” said David W. Parke II, MD, executive vice president and CEO of the Academy. “This year’s joint meeting is shaping up to be an outstanding event befitting the Academy’s hometown. The submission numbers surpass those for our 2006 meeting in Las Vegas, which ended up setting a new record for attendance. ”

The Academy received a total of 2,160 paper/poster submissions by the April 14 deadline, as well as 167 video abstract submissions. By contrast, the 2006 annual meeting saw 2,079 paper/poster submissions, and 177 video abstract submissions. In an average year, the Academy receives about 1,400 paper/poster abstracts and 150 video abstracts for its annual meeting.

The advance program for the 2009 Joint Meeting will be available online on June 1. Registration and housing opens to Academy, PAAO and American Academy of Ophthalmic Executive (AAOE) members on June 24. Registration for nonmembers, including media, opens on July 8.

About the American Academy of Ophthalmology

The Academy 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. To find an Eye M.D. in your area, visit the Academy’s Web site at aao

Source
American Academy of Ophthalmology

EyeGate Pharma, the leader in ocular drug delivery, a specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics to treat serious ocular diseases, today announced that it has enrolled the first dry eye patient in a Phase II safety and efficacy clinical study of EGP-437 (a combination drug/device). This patient enrollment marks the Company’s second clinical trial initiated in the second half of 2008. In July, the Company initiated a landmark Phase II clinical study in severe uveitis, which represented the first U.S. study under an open IND to employ iontophoresis technology to deliver an active compound into the eye.

EyeGate is partnering with Ophthalmic Research Associates (ORA), a leading global clinical research and development organization, located in North Andover, MA. Over the past 30 years, ORA has played a central role in the development and FDA approval of more than 25 ophthalmic products.

“Dry eye is the most prevalent form of ocular discomfort and irritation, and currently has no cure and few treatment options to alleviate symptoms that only provide temporary relief. It is estimated that as many as 20 to 40 million Americans suffer from mild-to-moderate dry eye. Symptoms such as pain, light sensitivity, blurred vision, and irritation decrease the quality of life for patients and can ultimately lead to loss of function and blindness,” commented George Ousler, Director of Dry Eye Research at ORA.

The Phase II study is a single-center, randomized, double-masked, placebo-controlled safety and efficacy study of two doses of a corticosteroid solution (EGP-437) over a period of three weeks in dry eye patients. ORA’s proprietary Controlled Adverse Environment (CAE) clinical model is being used in this study to support the clinical development of EGP-437.

This Phase II safety and efficacy study builds on a series of clinical trials, including a pilot and a Phase I study. The pilot study was instrumental in establishing EyeGate’s clinical development roadmap and was designed to assess the safety, tolerability, and efficacy of EyeGate’s first-generation iontophoretic drug delivery device. This trial included 89 patients suffering from a variety of severe ocular inflammatory conditions and involved a total of 216 iontophoretic applications of a corticosteroid. The treatments significantly decreased inflammatory markers and improved visual acuity while demonstrating exceptional safety and tolerability. The second study is a fully enrolled Phase I safety and tolerability study in 105 healthy volunteers. This GCP Phase I study is designed to establish the maximum tolerated current that can be employed with the EyeGate® II Delivery System. Data from this study aided dose selections for on-going trials and will provide valuable information for future clinical trials and support future regulatory filings. This Phase I study should be completed by the end of 2008.

Gail Torkildsen, M.D., of Ophthalmic Research Associates, principal investigator of the study, commented, “EyeGate’s non-invasive, patient-friendly approach of dosing EGP-437 with the Company’s ocular delivery system will be beneficial in treating dry eye patients. I look forward to working with EyeGate and reporting on the results of this important study.”

This U.S. Phase II safety and efficacy study utilizing the EyeGate® II Delivery System will administer the Company’s lead clinical compound, EGP-437, with the objective of assessing safety and efficacy in up to 80 dry eye patients.

Stephen From, President and Chief Executive Officer of EyeGate Pharma, commented, “The number of patients suffering from ocular diseases such as dry eye are increasing at a rapid rate due to a variety of demographical circumstances such as the aging population, evolving environmental conditions, and internal factors relating to heating and excessive computer use. Treatments such as artificial tear solutions only provide limited temporary symptomatic relief for this disorder. EyeGate is looking to provide a safe, patient-friendly alternative with longer lasting effect on the signs and symptoms of this impairing disease. We look forward to working with Ophthalmic Research Associates and finalizing results of this trial in early 2009.”

About Iontophoresis

The EyeGate® II Delivery System works through iontophoresis, which occurs when an applied electric field enhances the mobility of molecules through cells and tissues primarily through electrochemical repulsion. Specifically, a low level of electrical current creates an electrical field that repels like-charged ionized drugs, thus, more effectively delivering drug substances through different tissues to targeted areas in efficacious quantities. These principles can be applied to anionic and cationic molecules.

To deliver a therapeutic to both the anterior (front) and posterior (back) tissues of the eye, the drug must be specially adapted and formulated for iontophoretic delivery. EyeGate has concentrated its efforts on optimizing the EyeGate® II Delivery System to administer a wide range of therapeutics while developing a highly specialized laboratory dedicated to formulating drugs for iontophoretic delivery.

About EyeGate Pharma

EyeGate was founded in 1998 with technology licensed from Bascom Palmer Eye Institute at the University of Miami. EyeGate’s transscleral (white membrane of the eye) iontophoresis delivery platform, the EyeGate® II Delivery System, was developed to safely deliver a wide range of therapeutics to both the anterior and posterior chambers of the eye. For more information, please visit eyegatepharma.

About Ophthalmic Research Associates (ORA)

ORA is a drug development company that creates and deploys rigorous scientific and management processes that accelerate the pace of drug development and improve patient care for vision-related illnesses.

Ophthalmic Research Associates

The American Academy of Ophthalmology applauds the introduction of legislation to address misleading advertising by non-physicians that can lead to patient confusion about their provider’s qualifications. Ophthalmologists, who are medical doctors, are part of a coalition of specialty organizations whose goal is to eliminate patient uncertainty about the education, training and credentials of their health care providers.

The Healthcare Truth and Transparency Act of 2007, (H.R. 2260) introduced May 10 by Reps. John Sullivan, R-Okla. and Jim McDermott, D-Wash., protects patients by strengthening the Federal Trade Commission’s enforcement against limited-licensed health care providers, who are not medical doctors (MDs) or doctors of osteopathic medicine (DOs), intervening when they make false or misleading misrepresentations about their qualifications, education and training.

“This legislation is needed to protect patients, and we are excited to join in the effort to educate the public about this issue,” said Catherine G. Cohen, the Academy’s vice president for governmental affairs. “Our goal is to end patient confusion. Patients tell us again and again that they want this information and that they are confused by some marketing practices. Often patients believe they are seeing a medical doctor when, in fact, they are not.”

A telephone poll of 1,000 adults conducted in 2006 by Ipsos U.S. Express Omnibus Survey showed that the American public is largely unaware of the difference in education and training between limited-license health care practitioners and medical doctors. When educated they want to see an MD, so they want information on who is or is not an MD. The survey found 86 percent of Americans support federal legislation that would make it easier for patients to understand the qualifications of their health care professionals and 90 percent believe that someone who is not a medical doctor should make it clear to the patient before they provide treatment.

“All providers are of vital importance to our health care system, but deceptive advertising and misrepresentation of qualifications are a real concern,” added Rep. Sullivan. “The Healthcare Truth and Transparency Act of 2007 is a first step in addressing these important issues and reducing patient confusion.”

The American Academy of Ophthalmology is the voice for ophthalmologists and their patients in Washington D.C., and is the world’s largest organization of eye physicians and surgeons, with more than 27,000 members.

www.aao