News From Ophthalmology Research, April 2009

Highlights of April’s Ophthalmology, the journal of the American Academy of Ophthalmology (Academy), include the first international, peer-reviewed report on LASIK patient satisfaction, data on increased cataract risk in patients who use combined steroids, and the first large study of refractive error and vision correction in American preschool children.

Comprehensive Review Confirms High LASIK Patient Satisfaction

This peer-reviewed report provides a systematic worldwide overview of LASIK patient satisfaction as of 2008. Report findings were first released last year by the American Society of Cataract and Refractive Surgery (ASCRS). LASIK has been assessed and improved by more than a decade of clinical studies and technological innovation since the procedure was introduced. The report notes that 16.3 million surgeries have been performed worldwide to date, and about one million LASIK surgeries are done annually in the United States.

The review found an overall patient satisfaction rate of 95.4 percent (2,097 of 2,198 subjects), with a range of 87.2 to 100 percent. “This places LASIK among the most successful of all elective surgeries, comparing very favorably with other elective procedures,” said lead researcher Kerry D. Solomon, MD, Magill Vision Center and Storm Eye Institute, Medical University of South Carolina. “Because this review process was systematic, transparent, and based on carefully vetted international and U.S. research, the findings are highly reliable.” Measuring patient satisfaction is increasingly important in health care. For an elective surgery like LASIK, satisfaction criteria include whether the patients’ physical, emotional, and financial expectations are met and physical and psychological benefits achieved.

The researchers looked at whether patient satisfaction with LASIK has changed over time by comparing rates for surgeries performed 1995 to 2000 with those performed 2001 and after. The rate was 96.0 percent in the earlier period and 94.6 percent in the later period, confirming consistently high patient satisfaction. The review also analyzed satisfaction rates in relation to questionnaire characteristics, administration methods and timing, type of patient refractive error (near- or farsightedness, astigmatism) and country. All analyses showed very high overall patient satisfaction rates. Questionnaires used in all studies allowed patients to rate their satisfaction on graduated scales, from “satisfied” to “dissatisfied.” Five articles offered an “undecided” category, and patients who selected this option were not included in the review analysis.

The research team reviewed 19 studies from 13 countries representing the U.S. and most areas of the world, encompassing 2,198 subjects who had LASIK between 1995 and 2003. A comprehensive international literature search performed by a Storm Eye Institute panel had indentified 309 peer-reviewed, well-designed studies of primary (original) LASIK surgery, of which 19 reported on both patient quality of life and satisfaction. All were randomized, controlled clinical trials, or cohort or case-controlled studies.

Inhaled and Oral Steroid Use Impacts Cataract Risk

A study conducted by the Centre for Vision Research, University of Sydney, Australia, examines how steroid (corticosteroid) use relates to risks for cataract, the clouding of the eye’s lens that leads to reduced vision and blindness, if untreated. Many people with asthma rely on inhaled, and sometimes oral, steroids, as do people with chronic obstructive pulmonary disease (COPD). This population-based study, a cohort of the Blue Mountains Eye Study, followed 3,654 Australians, aged 49 years or older, five and 10 years after initial (baseline) examinations conducted between 1992 and 1994. This timeframe was needed to assess the long-term impact of steroid use on cataracts, which develop slowly over years. Based on their findings, the researchers suggest that more judicious prescription of combined inhaled and oral steroids may decrease cataract risk for asthma patients.

“Our findings could mean that combined steroid use, when it results in high cumulative dosage over relatively long periods, increases risks for two types of cataract,” said lead researcher, Jie Jin Wang, MMed, PhD, Centre for Vision Research. “When clinicians prescribe both steroid forms, the cumulative, combined dose should be considered. Also, recent clinical trials indicate that combined steroids are not more effective than inhaled steroids alone in treating asthma.” He added that further investigation is needed to determine whether asthma plays a role in nuclear cataract development.

Elevated cataract risks were found only in patients who, at the time of their baseline exams, had ever used inhaled steroids, had also used oral steroids for at least one month, and had no cataracts. Patients at highest risk for two types of cataract were those defined at baseline as “current users” of both steroid forms; although this was a small group, follow up exams found that nearly all of them developed cataracts. Of seven current user patients, five had used either steroid form for more than five years, and four of the five developed posterior subcapsular cataract (PSC). Three additional current user patients developed nuclear cataracts. In nuclear cataracts the center of the lens is obscured, and in PSC the cataract develops in the rear area of the lens. Earlier research had established a higher risk for PSC in oral steroids users.

First Large Study of Preschool Children’s Vision Finds Need for Improved Care

This new report on an element of the Baltimore Pediatric Eye Disease Study (BPEDS) provides the first population-based data on refractive error and the need for vision correction in American preschool-aged children. Researchers tested 2,546 African-American and non-Hispanic white children for nearsightedness, farsightedness and astigmatism. BPEDS was conducted between 2003 and 2007 in the urban area in and around Baltimore, Maryland. Like school-aged children, very young children who have undetected, uncorrected refractive errors are at risk for a number of visual disorders including amblyopia, in which vision in one eye is weaker than the other, and strabismus, in which one eye does not align properly. If children with a high degree of farsightedness do not receive vision correction, strabismus can result. Most often the disorder can be corrected if eyeglasses are prescribed.

The study found that 5.1 percent of participating children had refractive errors that would benefit from prescription eyeglasses, based on current correction standards for this age range. Also, 10 of 29 children who had been prescribed glasses prior to their BPEDS exams were found not to need glasses. Farsightedness was the most common refractive error among both African-Americans (4.4 percent) and white children (8.9 percent); these rates did not change significantly as the children aged.

“The unmet need for refractive correction plus the prescription of unnecessary glasses for some children suggest that the quality of eye care for children in the Baltimore urban area needs to be improved,” said David S. Friedman, MD, MPH, PhD, the Wilmer Eye Institute, Johns Hopkins School of Medicine, who led the study. In 2008 Maryland passed a law intended to improve vision screening of school-age children; the preschool age group was not addressed by this law.


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.

Mary Wade

American Academy of Ophthalmology

Journal Of Vision Issue Breaks New Ground With A Collection Of The Latest In Imaging Studies In Vision

Researchers are making great strides in using imaging techniques to explore the human
brain and visual system. On August 1, the Journal of Vision (JOV) opened a special issue
dedicated to neuroimaging in vision science (journalofvision/8/10/). For the first
time, JOV gives vision researchers of varied methodological persuasions access to a
collection of high-quality imaging studies of visual processing.

JOV is a free-access, online-only publication produced by the Association for Research in
Vision and Ophthalmology. Published monthly, the journal focuses on all aspects of visual
function in humans and in other organisms.

The neuroimaging special edition opens with five articles, as well as links to two related
articles published earlier. JOV will continue to publish articles on neuroimaging in vision
science through the end of 2008 as they are ready for publication.

Andy Smith, PhD, of Royal Holloway, University of London is one of the four editors of JOV’s
neuroimaging issue (along with David Heeger, New York University; Geoff Boynton,
University of Washington; and Anthony Norcia, Smith-Kettlewell Eye Research Institute).

Prof. Smith said: “The special issue reflects the confluence of two key trends in
neuroscience. First, the sense systems (and particularly vision) are at the forefront of
neuroscience research, because that is where the problem of understanding brain function is
most tractable. Second, brain imaging is currently enabling spectacular progress in linking
neurophysiological knowledge with behavioural research.

“We hope that the collection serves a useful scientific purpose in itself, but we also hope
that it may stimulate an increase in the number of imaging submissions to JOV in the

“JOV’s editors, reviewers and readers constitute the bulk of expertise in this field,” added
Prof. Norcia. “Now that the technical details of many of these techniques have been brought
to a high level, the focus should now properly be on what the data obtained from these
increasingly mature technologies have to say specifically about vision and more generally
about brain function.”

ARVO is the largest eye and vision research organization in the world. Members include more than 12,500 eye and
vision researchers from over 73 countries. The Association encourages and assists research, training, publication
and dissemination of knowledge in vision and ophthalmology.


New Technique Captures High Resolution Images Of Full Retina

Researchers used a new imaging technique to take high quality color photographs of the clinical stages of ocular inflammation in mice, and the technology could help in the monitoring and treatment of diseases of the eye that may cause blindness.

The study, “The Clinical Time-Course of Experimental Autoimmune Uveoretinitis Using Topical Endoscopic Fundal Imaging with Histologic and Cellular Infiltrate Correlation,” was published in the Association for Research in Vision and Ophthalmology journal Investigative Ophthalmology and Visual Science (Invest. Ophthalmol. Vis. Sci. 2008 49: 5458-5465).

It featured the use of Topical Endoscopic Fundal Imaging (TEFI), a technique that uses an endoscope with parallel illumination and observation channels connected to a digital camera. TEFI was developed by Michel Paques, et al (see Invest. Ophthalmol. Vis. Sci. 2007 48: 2769-2774).

David Copland, BSc, MSc, and the team from the University of Bristol’s Academic Unit of Ophthalmology monitored changes in the mice retina over time without distress to the animals or the need for anesthesia.

“TEFI enhances our monitoring of clinical disease in a rapid and non-invasive fashion,” the researchers reported. “It will aid in the design of experimental protocols according to clinical observations.”

The study focused on a condition similar to human posterior uveitis, which can be difficult to monitor using present techniques. TEFI allowed the researchers to see changes to the eye that were previously undetectable.

The researchers wrote that TEFI can help monitor the effects of new ocular therapies, as well as invasive procedures such as intravitreal or sub-retinal injections.

Though the method will be a helpful resource to improving detection, Copland’s team said the technology should be used in conjunction with existing techniques for monitoring the progression of eye diseases.

“Combined TEFI and histological methods enable the observation of clinical features and severity of disease, but information regarding the dynamics, phenotype, function and quantity of cellular traffic through the eye is only provided through detailed analysis of cell populations present in the eye at various stages of disease progression.”


ARVO is the largest eye and vision research organization in the world. Members include more than 12,500 eye and vision researchers from over 73 countries. The Association encourages and assists research, training, publication and dissemination of knowledge in vision and ophthalmology. For more information, visit arvo.

Joanne Olson
Association for Research in Vision and Ophthalmology

OrthoAccel Technologies, Inc. Announces Definitive Distribution Agreements In Two Key Markets

OrthoAccel Technologies, Inc. announced this week that it has finalized distribution agreements with two key partners: AB Orthodontics Pty Ltd in Melbourne, Australia, and Inno Dental and Medical Corporation (Inno DMC), based in Seoul, South Korea.

The AcceleDent System is currently being sold to select orthodontic specialists in the United Kingdom, where it was introduced last year through a limited release market program. The lightweight device, used to speed up the rate of orthodontic treatment, is intended for 20 minutes of daily use. Patients simply bite down on the Mouthpiece to hold it in place, which allows freedom of the hands to engage in other routine, daily activities during the treatment session. Patients have reported using the device while engaged in a variety of activities, including homework, watching television and commuting to work. The Company has reported plans for a general market release in the United Kingdom in September, at the British Orthodontic Conference in Brighton.

Mike Kaufman, VP of Marketing and Business Development for OrthoAccel commented, “Australia and South Korea are key international markets for us and allow us to develop product awareness and success stories in advance of a future release in other international markets and the United States.”

This definitive distribution agreement between OrthoAccel and AB Orthodontics formalizes the intent to partner together that was reported by the two companies in May. ” The AcceleDent device has received much positive interest from the Australian orthodontic community including academics and researchers. Some orthodontists have reported excellent initial results, especially in cases where tooth movement has been very slow or virtually unachievable,” stated Andrew Binns, Managing Director. On October 18-22 AB Orthodontics is preparing to host AcceleDent seminars in Sydney, Melbourne and Brisbane with Dr. Asif Chatoo as the keynote speaker. Dr Chatoo, who practices at the Lingual Orthodontic Clinic, was among the first users of the AcceleDent System in the United Kingdom.

The agreement with Inno DMC marks OrthoAccel’s first movement into the Asia Pacific region. Mr. Sung-ku Hong, CEO of Inno DMC, commented, “AcceleDent is an exciting and new innovative technology with the potential to offer significant time savings to the patient and practice efficiencies to the orthodontist.” Mike Kaufman added, “OrthoAccel first had the opportunity to meet with Mr. Hong during the 2010 AAO meeting and we immediately appreciated the depth and experience of Inno DMC and how their relationships with the orthodontic community would benefit our efforts in South Korea.” Although commercial sales are not anticipated until next year because regulatory details must be finalized, efforts to begin increasing awareness and educating dental professionals will begin immediately.

Source: OrthoAccel Technologies, Inc

News From The Journal Of Clinical Investigation: Dec. 6, 2010

DERMATOLOGY: Targeting blood vessel growth to treat psoriasis

Psoriasis is a common skin disorder that arises when immune cells become overactive and generate unneeded inflammatory responses in the skin. Dysregulated growth of new blood vessels from pre-existing vessels (a process known as angiogenesis) is one hallmark of psoriasis, which is also characterized by thick silvery scales on affected areas of skin and itchy, dry, red patches. A team of researchers, led by Michael Sch?�n, at Georg August University, Germany, has now found that reducing angiogenesis in xenotransplantation models of psoriasis and in mice with a disease that resembles psoriasis alleviates disease. They therefore suggest that their non-viral gene therapy approach to reducing angiogenesis might provide a new approach to treating psoriasis and, perhaps, other inflammatory skin disorders characterized by dysregulated angiogenesis.

TITLE: Halting angiogenesis by non-viral somatic gene therapy alleviates psoriasis and murine psoriasiform skin lesions

VIROLOGY: How hepatitis C virus uses the cells it infects to its own advantage

The current therapy to treat individuals infected with hepatitis C virus (HCV) works in only about half of those treated. Therefore, many individuals remain chronically infected with HCV, something that often leads to liver failure and liver cancer. Research using human liver cell lines, performed by Po-Yuan Ke and Steve Chen, at Academia Sinica, Taiwan, has identified new ways in which HCV coopts normal cellular processes in the cells that it infects to enhance its reproduction and to evade certain aspects of the antiviral immune response. These data not only provide new insight into the ways in which interactions between HCV and the cells it infects can benefit the virus, but also provide potential new avenues of research for the development of novel therapeutic approaches to clearing HCV infection.

TITLE: Activation of the unfolded protein response and autophagy after hepatitis C virus infection suppresses innate antiviral immunity in vitro

PULMONARY: Pinpointing a role for the molecule TGF-beta in lung scarring

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disorder for which there are currently no treatments. It is a progressive disease that results in lung scarring and changes in lung architecture, which together lead to loss of lung function and death. Although the cause(s) of IPF is unclear, dysregulated signaling triggered by the molecule TGF-beta is known to have a role in disease development. Parviz Minoo, Zea Borok, and colleagues, at the University of Southern California, Los Angeles, have now been able to more specifically pinpoint the role of dysregulated TGF-beta signaling in disease development using a mouse model of lung fibrosis (scarring).

The researchers generated mice lacking T-beta-RII – the molecule to which TGF-beta binds to trigger a signaling cascade – on cells lining the lung (epithelial cells). Importantly, these mice showed increased survival and resistance to fibrosis in the chemical-induced model of fibrosis studied. The authors therefore suggest that T-beta-RII could provide a new target for the development of therapeutics to treat IPF.

TITLE: Epithelium-specific deletion of TGF-beta receptor type II protects mice from bleomycin-induced pulmonary fibrosis

MUSCLE BIOLOGY: Linking two previously disparate muscle diseases

Individuals with mutations in their DES gene have dysfunctional muscle fibers in their skeletal and heart muscle (conditions termed myopathy and cardiomyopathy, respectively). This leads to progressive skeletal muscle weakness and heart failure. A team of researchers, led by Jocelyn Laporte, at the Institut de G?�n?�tique et de Biologie Mol?�culaire et Cellulaire, France, has now determined that the mechanisms underlying disease in individuals with a previously unrelated form of inherited myopathy (X-linked centronuclear myopathy [XLCNM]) are similar to those in individuals with DES gene mutations. Specifically, they found that the protein generated by the gene mutated in individuals with XLCNM (MTM1) binds desmin (the product of the DES gene) and ensures normal desmin expression and localization in both both mouse and human skeletal muscles. These and other data in the paper lead the authors to suggest that XLCNM and desmin-related myopathy, two conditions thought previously to be unrelated, have common disease-related features.

TITLE: Myotubularin controls desmin intermediate filament architecture and mitochondrial dynamics in human and mouse skeletal muscle

OPHTHALMOLOGY: Support for light-sensing cells eroded by the mTOR signaling pathway

The retina is the light-sensitive tissue that lines the inner surface of the eye. It consists of light-sensitive nerve cells known as photoreceptors and cells that support and nourish the photoreceptors, which are known as retinal pigment epithelial (RPE) cells. RPE cell dysfunction leads to retinal degeneration and loss of visual acuity. A team of researchers, led by Douglas Vollrath, at Stanford University School of Medicine, Stanford, has now determined in mice that stresses that disrupt the function of the energy generating compartments within RPE cells (mitochondria) trigger RPE cell dedifferentiation and that this leads to decreased responsiveness of photoreceptor cells to light and their eventual degeneration. Further analysis revealed that RPE cell dedifferentiation involved the signaling protein mTOR and that the mTOR inhibitor rapamycin protected photoreceptor function in response to RPE stresses. The authors therefore suggest that mTOR pathway inhibitors might provide a new approach to treating individuals with retinal degenerative diseases involving RPE stress.

TITLE: mTOR-mediated dedifferentiation of the retinal pigment epithelium initiates photoreceptor degeneration in mice

IMMUNOLOGY: Understanding how single immune cells “see” their target

Key to designing effective vaccines and immune-based therapeutics for the treatment of autoimmune diseases such as rheumatoid arthritis is characterizing in detail the immune cells (T cells) that naturally respond to the microbe or cause the autoimmune disease. One facet of this characterization is to define very specifically the protein complex expressed by T cells (the T cell receptor [TCR]) that enables them to “see” their target and respond to microbes or cause autoimmunity. A team of researchers, led by Paul Thomas, at St Jude Children’s Research Hospital, Memphis, has now developed a new method to examine the TCR expressed by an individual T cell, an approach that they hope will prove of tremendous use for researchers studying mouse models of human disease.

TITLE: Paired analysis of TCR-alpha and TCR-beta chains at the single-cell level in mice

Karen Honey

Journal of Clinical Investigation

Potentia Pharmaceuticals Announces Initiation Of Phase I Clinical Trials To Evaluate Its Lead Compound For Age-Related Macular Degeneration

Potentia Pharmaceuticals,
Inc. announced today that it is entering the clinical phase of development
for POT-4, its lead drug candidate for the treatment of age-related macular
degeneration (AMD). POT-4 is a complement inhibitor, which shuts down the
complement activation system that could lead to local inflammation, tissue
damage and upregulation of angiogenic factors such as vascular endothelial
growth factor (VEGF).

Four landmark studies published in April 2005 demonstrated a genetic
link between the complement system and AMD, providing evidence that
complement activation plays a significant role in the cause of the disease.
Less than two years after the publication of the studies, POT-4 will be the
first complement inhibitor tested in patients with AMD.

“These recent data have sparked hope that AMD can be treated with
complement inhibitors, which help treat the early stages of the disease. We
are hopeful that POT-4 may represent a new therapeutic option for patients
with dry and wet forms of the disease,” said Cedric Francois, M.D., Ph.D.,
Potentia’s President and CEO.

AMD is the leading cause of blindness in the elderly of the western
world and affects more than 10 million patients in the United States alone.
The current standard of care for AMD relies primarily on angiogenesis
inhibitors, an approach geared towards the approximately 10-15% of AMD
patients with complications resulting from ocular angiogenesis (growth of
new blood vessels and bleeding in the back of the eye). No drug currently
on the market has been approved for the treatment of the remaining
patients, who suffer from the so-called “dry” form of the disease.

About the Complement System and POT-4

Complement activation is an inflammatory process involving dozens of
plasma proteins, ultimately leading to cell membrane disruption through the
membrane attack complex. Activation of the complement system is an
important part of the body’s defensive immune response against pathogens
such as bacteria and viruses. In spite of its defensive function,
inappropriate or excessive complement activation can have pathological
consequences. Multiple studies published over the past 2 years have
strongly linked the complement system to the pathology of AMD.

POT-4 is a synthetic peptide discovered by Professor John Lambris at
the University of Pennsylvania. It binds tightly to complement component
C3, preventing its participation in the complement activation cascade. As
C3 is the central component of all major complement activation pathways,
its inhibition effectively shuts down all downstream complement activation
that could otherwise lead to local inflammation, tissue damage and
upregulation of angiogenic factors such as vascular endothelial growth

About Age-Related Macular Degeneration

AMD is the progressive deterioration of the critical central region of
the retina called the macula. This disorder leads to irreversible loss of
central vision. More than 25 million patients worldwide suffer from AMD,
including roughly one-quarter of those 70 years and older. Ten to fifteen
percent of patients with AMD develop a complication in which leaky blood
vessels grow into the retina. This form of the disease is referred to as
‘neovascular’ or ‘wet’ AMD, as opposed to ‘atrophic’ or ‘dry’ AMD when this
complication does not emerge. Pharmacological treatments of AMD are
primarily limited to drugs that inhibit blood vessel growth and leakage and
are therefore approved for use only in patients with wet AMD.

About Potentia’s AMD Program

With the ultimate goal of making AMD a preventable disease, Potentia’s
AMD program focuses on developing new therapies that target AMD early in
the disease process. Potentia’s AMD pipeline includes POT-4 formulated to
protect patients from the disease for prolonged periods of time after each

About Potentia Pharmaceuticals, Inc.

Potentia Pharmaceuticals, Inc. (potentiapharma/) is a
privately held, biotechnology company based in Louisville, KY. Together
with its corporate and academic partners, Potentia is developing new
approaches to the treatment of complement-related inflammatory diseases
such as AMD.

This press release contains “forward-looking statements” regarding the
potential therapeutic benefits and progress of Potentia’s research and
development programs. These statements are hereby identified as
“forward-looking statements”. Forward-looking statements include statements
regarding Potentia’s expectations, beliefs, intentions or strategies
regarding the future and include statements containing forward-looking
words such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “should,” “will,” and “would” or similar words. Such
statements are based on our management’s current expectations and involve
risks and uncertainties. Actual results and performance could differ
materially from those projected in the forward looking statements as a
result of many factors, including, without limitation, uncertainties
relating to drug discovery; formulation development; clinical development
processes; enrollment rates for patients in our clinical trials; changes in
relationships with strategic partners and dependence upon strategic
partners for the performance of certain activities under collaborative
agreements; the impact of competitive products and technological changes;
uncertainties relating to patent protection and uncertainties relating to
our ability to obtain funding. Potentia disclaims any intent or obligation
to update this press release or forward-looking statements contained

Our logo, trademarks, and service marks are the property of Potentia
Pharmaceuticals, Inc. All other trade names, trademarks, or service marks
are property of their respective owners.

Potentia Pharmaceuticals, Inc.

New Cataract Early Detection Technique: Patients And Astronauts Benefit From NEI-NASA Collaboration

A compact fiber-optic probe developed for the space program has now proven valuable for patients in the clinic as the first non-invasive early detection device for cataracts, the leading cause of vision loss worldwide.

Researchers from the National Eye Institute (NEI), part of the National Institutes of Health, and the National Aeronautics and Space Administration (NASA) collaborated to develop a simple, safe eye test for measuring a protein related to cataract formation. If subtle protein changes can be detected before a cataract develops, people may be able to reduce their cataract risk by making simple lifestyle changes, such as decreasing sun exposure, quitting smoking, stopping certain medications and controlling diabetes.

“By the time the eye’s lens appears cloudy from a cataract, it is too late to reverse or medically treat this process,” said Manuel B. Datiles III, M.D., NEI medical officer and lead author of the clinical study. “This technology can detect the earliest damage to lens proteins, triggering an early warning for cataract formation and blindness.”

The new device is based on a laser light technique called dynamic light scattering (DLS). It was initially developed to analyze the growth of protein crystals in a zero-gravity space environment. NASA’s Rafat R. Ansari, Ph.D., senior scientist at the John H. Glenn Research Center and co-author of the study, brought the technology’s possible clinical applications to the attention of NEI vision researchers when he learned that his father’s cataracts were caused by changes in lens proteins.

Several proteins are involved in cataract formation, but one known as alpha-crystallin serves as the eye’s own anti-cataract molecule. Alpha-crystallin binds to other proteins when they become damaged, thus preventing them from bunching together to form a cataract. However, humans are born with a fixed amount of alpha-crystallin, so if the supply becomes depleted due to radiation exposure, smoking, diabetes or other causes, a cataract can result.

“We have shown that this non-invasive technology that was developed for the space program can now be used to look at the early signs of protein damage due to oxidative stress, a key process involved in many medical conditions, including age-related cataract and diabetes, as well as neurodegenerative diseases such as Alzheimer’s and Parkinson’s,” said NASA’s Dr. Ansari. “By understanding the role of protein changes in cataract formation, we can use the lens not just to look at eye disease, but also as a window into the whole body.”

The recent NEI-NASA clinical trial, reported in the December 2008 Archives of Ophthalmology, looked at 380 eyes of people aged 7 to 86 who had lenses ranging from clear to severe cloudiness from cataract. Researchers used the DLS device to shine a low-power laser light through the lenses. They had previously determined alpha-crystallin’s light-scattering ability, which was then used to detect and measure the amount of alpha-crystallin in the lenses.

They found that as cloudiness increased, alpha-crystallin in the lenses decreased. Alpha-crystallin amounts also decreased as the participants’ ages increased, even when the lenses were still transparent. These age-related, pre-cataract changes would remain undetected by currently available imaging tools.

“This research is a prime example of two government agencies sharing scientific information for the benefit of the American people,” said NEI director Paul A. Sieving, M.D., Ph.D. “At an individual level, this device could be used to study the effectiveness of anti-cataract therapies or the tendency of certain medications to cause cataract formation.”

The DLS technique will now assist vision scientists in looking at long-term lens changes due to aging, smoking, diabetes, LASIK surgery, eye drops for treating glaucoma, and surgical removal of the vitreous gel within the eye, a procedure known to cause cataracts within six months to one year. It may also help in the early diagnosis of Alzheimer’s disease, in which an abnormal protein may be found in the lens. In addition, NASA researchers will continue to use the device to look at the impact of long-term space travel on the visual system.

“During a three year mission to Mars, astronauts will experience increased exposure to space radiation that can cause cataracts and other problems,” Dr. Ansari explained. “In the absence of proper countermeasures, this may pose a risk for NASA. This technology could help us understand the mechanism for cataract formation so we can work to develop effective countermeasures to mitigate the risk and prevent it in astronauts.”

The NASA John H. Glenn Research Center is one of NASA’s 10 field centers, empowered with the resources for developing cutting-edge technologies and advancing scientific research that addresses NASA’s mission to pioneer the future in space exploration, scientific discovery and aeronautics research. Working in partnership with government, industry and academia, the Center serves to maintain the U.S. economy’s global leadership while benefiting the lives of people around the world. For more information about NASA Glenn and its programs, visit grc.nasa.

The National Eye Institute (NEI) is part of the National Institutes of Health (NIH) and is the Federal government’s lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI Website at nei.nih/.

The National Institutes of Health (NIH) – The Nation’s Medical Research Agency – includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.

Source: NEI News Office

NIH/National Eye Institute

Enrollment Complete In Pivotal Phase 3 Trial Of Medidur(TM) FA For Diabetic Macular Edema

Alimera Sciences Inc., a privately held
ophthalmic pharmaceutical company, and pSivida Limited (Nasdaq: PSDV; ASX:
PSD; Xetra: PSI), announced that enrollment is complete for the
FAME(TM) (Fluocinolone Acetonide in Diabetic Macular Edema) Study of
Medidur(TM) FA for the treatment of Diabetic Macular Edema. FAME is a
double masked, randomized, multi-center study that is following over 900
patients in the U.S., Canada, Europe and India for 36 months with safety
and efficacy assessed at two years. Alimera Sciences and pSivida are
jointly developing Medidur FA under a collaborative research and
development agreement.

“Alimera Sciences is very excited to have completed enrollment in the
FAME Study as this brings us closer to taking Medidur FA, the next
generation of retinal drug delivery, to market and to our ultimate goal of
delivering treatments that enrich patients’ quality of life,” said Alimera
CEO Dan Myers.

Medidur, a tiny, injectable insert, is being studied as a way to
deliver fluocinolone acetonide, a corticosteroid, to the retina for up to
three years as a treatment for diabetic macular edema (DME). Using a
proprietary 25 gauge injector system, an eye care professional injects the
Medidur insert into the vitreous through a minimally invasive procedure in
an outpatient setting.

“This marks an important milestone for the company in our profit
sharing collaboration with Alimera. We are very pleased at the continued
development of Medidur FA, based on our technologies that have already been
approved for two back of the eye diseases. We are optimistic that Medidur
FA will offer a solution to the large market we see for this product,” said
pSivida Limited Managing Director, Dr Paul Ashton.

Diabetic retinopathy (DR), a complication of diabetes mellitus, is the
leading cause of blindness in the working-age population of developed
countries. At any time during progression of diabetic retinopathy, patients
can develop DME which involves retinal thickening of the macular area. More
than 500,000 people live with DME in the United States and this number is
expected to exceed 700,000 by the year 2010. Currently there are no FDA
approved drug treatments for DME.

About Alimera Sciences Inc.

Alimera Sciences Inc., a venture backed company, specializes in the
development and commercialization of prescription ophthalmology
pharmaceuticals. Founded by an executive team with extensive development
and revenue growth expertise, Alimera Sciences products are focused on
improving the delivery of therapeutic agents to enhance patients’ lives and
strengthen physicians’ ability to manage ocular conditions. Alimera is
currently conducting a phase 3 clinical trial of fluocinolone acetonide in
the Medidur(TM) drug delivery system for the treatment of diabetic macular
edema. For more information, please visit alimerasciences

About pSivida Limited

pSivida is a global drug delivery company committed to the biomedical
sector. Retisert(R) is FDA approved for the treatment of uveitis.
Vitrasert(R) is FDA approved for the treatment of AIDS-related CMV
Retinitis. Bausch & Lomb own the trademarks Vitrasert(R) and Retisert(R).
pSivida has licensed the technologies underlying both of these products to
Bausch & Lomb. The technology underlying Medidur(TM) for diabetic macular
edema is licensed to Alimera Sciences and is in Phase III clinical trials.
pSivida has a worldwide collaborative research and license agreement with
Pfizer Inc. for other ophthalmic applications of the Durasert(TM)
technology which underpins the Medidur product.

pSivida owns the rights to develop and commercialize a modified form of
silicon (porosified or nano-structured silicon) known as BioSilicon(TM),
which has applications in drug delivery, wound healing, orthopedics, and
tissue engineering. The most advanced BioSilicon(TM) product, BrachySil(TM)
delivers a therapeutic, P32 directly to solid tumors and is presently in
Phase II clinical trials for the treatment of pancreatic cancer. For more
information, please visit psivida

Various statements made in this release are forward-looking and involve
a number of risks and uncertainties. All statements that address
activities, events or developments that we intend, expect or believe may
occur in the future are forward-looking statements. The following are some
of the factors that could cause actual results to differ materially from
the forward-looking statements: the risks that we will not be able to raise
additional capital; that we will continue to incur losses and may never
become profitable; that we will be required to pay penalties pursuant to
registration agreements with securities holders and not have sufficient
funds to do so; that we will be unable to develop new products; that we
will be unable to protect our own intellectual property or will infringe on
others’ intellectual property; that we will not receive regulatory
approvals necessary to commercialize products; that we will be unable to
secure partners necessary to develop and market products; that our current
licensees will terminate their agreements with us; that our competitors’
products will receive regulatory approval before, reach the market before,
or otherwise receive better market acceptance than, our product candidates;
that our international business operations will result in increased costs
or delays; that manufacturing problems will delay product development and
commercialization; that third-party reimbursement and health care providers
will not cover the costs of our products; that we will fail to retain some
or all of our key personnel; we will be subject to product liability suits
and not have sufficient insurance to cover damages; that we will fail to
effectively manage changes in our business; that we will fail to comply
with environmental laws and regulations; that we will fail to achieve and
maintain effective internal control over financial reporting; that
amortization or impairment of other intangibles will adversely affect our
operating results; that our being headquartered outside of the United
States will make it difficult to effect legal services against us or our
management, lead to adverse shareholder tax consequences, or otherwise
limit shareholder rights; that we will be delisted from the ASX or NASDAQ;
that our expectation to not pay cash dividends will decrease our stock
price; that exercise of outstanding warrants and stock options will dilute
ownership and reduce stock price; that future stock issuances could dilute
ownership, restrict operations, encumber assets, or otherwise cause a
decline in stock price; and the risk that Pfizer will influence our
business in non-beneficial ways; and other factors that may be described in
our filings with the Securities and Exchange Commission. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. We do not undertake to publicly update or
revise our forward-looking statements even if experience or future changes
make it clear that any projected results expressed or implied in such
statements will not be realized.

Alimera Sciences Inc.

Free Radicals In Cornea May Contribute To Fuchs Dystrophy, Most Common Cause Of Corneal Transplants

Scientists have found that free radicals (unstable molecules that cause the death of cells as the body ages) may also cause the damage in the eyes of patients with Fuchs Endothelial Corneal Dystrophy (FECD), a hereditary disease that is one of the most common reasons for corneal transplants worldwide.

The finding, published in the November 2010 American Journal of Pathology, holds promise for early and preventative treatments for this disease, which impacts nearly four percent of the population over age 60.

“Our discovery is significant, because it gives us the first hope for slowing the progression of the disease,” says Dr. Ula V. Jurkunas, the principal investigator of the study, who is a scientist at Schepens Eye Research Institute and a corneal surgeon at Massachusetts Eye and Ear Infirmary in Boston. “If we can identify how free radicals are involved in this and what antioxidants can fight them, we can create a regimen that can help protect the cornea,” she adds. (Antioxidants are molecules such as vitamins or certain proteins that bind with and neutralize free radicals.)

FECD destroys cells in the endothelial or deepest layer of the cornea, which is the clear tissue that makes up the front portion of the eye. These endothelial cells are equipped with pumps that expel excess water from the cornea and keep it clear. Without these cells, the cornea swells and vision clouds, and, in the late stages, vision is completely blocked.

Because corneal endothelial cells do not regenerate themselves, the only effective treatment for Fuchs has been corneal transplant, in which a surgeon removes the injured layer and replaces it with the donor endothelium.

While scientists have made progress in identifying some genes that cause the disease, they have made little or no progress in defining the mechanisms at play.

As a surgeon who performs hundreds of transplants, Jurkunas began to believe that a free radical process might be part of what is happening within the Fuchs dystrophy-plagued cornea. Free radicals are unstable molecules released by the body, which destabilize other molecules through a process known as oxidization, which causes cell death. Antioxidants are known to bind with and neutralize free radicals.

To test the theory, Jurkunas and her colleagues took numerous tissue samples from patients undergoing corneal transplants and tested them for evidence of free radical oxidation and subsequent tissue damage.

In the significant majority of specimens, the scientists found that the level of antioxidants was less than normal (or down-regulated). They also found evidence of high rates of damage to the cells’ DNA, which is particularly susceptible to free radicals.

According to Jurkunas, the next step is to identify the specific antioxidants that would neutralize the free radicals involved in the damage and, therefore, could prevent or block their destructive action.

What should patients do in the meantime? While no conclusions should be drawn from these early results, Jurkunas recommends that patients at risk for Fuchs eat a healthy diet rich in leafy green vegetables, such as broccoli and Brussels sprouts, take multivitamins and wear UV protection outdoors.

Other scientists involved in the study are: Dr. Maya S. Bitar, Dr. Toshinari Funaki, and Dr. Behrooz Azizi, also from both Schepens Eye Research Institute and Massachusetts Eye and Ear Infirmary.

The study was conducted at Jurkunas’ laboratory at Schepens Eye Research Institute. Tissue samples were donated by the surgeons and patients of the Massachusetts Eye and Ear Infirmary and Ophthalmic Consultants of Boston.

Source: Schepens Eye Research Institute

OSA “Frontiers In Optics” Annual Meeting Celebrates 90th Anniversary Of Innovation In Optics, NY, October 8-12

The Optical Society of America’s (OSA) Annual Meeting, Frontiers in Optics 2006, will cover the breadth of optical science and engineering. This meeting, co-located with Laser Science XXII, the annual meeting of the American Physical Society (APS) Division of Laser Science, unites these communities for five days of cutting-edge content, powerful networking and opportunities for scientific exchange. Exhibits featuring 80+ leading optics companies will complement the in-depth educational programming and offer attendees a glimpse of the latest optical technologies and products.

WHAT: The Optical Society of America’s Annual Meeting – Frontiers in Optics 2006

WHERE: Rochester Convention Center, Rochester, New York, USA

WHEN: Sunday, October 8 – Thursday, October 12

WHY COME – PROGRAM HIGHLIGHTS: Frontiers in Optics 2006 marks 90 years of optics innovation as the 90th Annual Meeting of the Optical Society of America. Highlights include:

Frontiers in Optics plenary session will focus on timely global issues, highlighting solutions in optics.

Featured sessions are:

* The Energy Problem and What We Can Do About It, Steven Chu, Nobel Laureate, 1997 Nobel Prize in Physics, Lawrence Berkeley Natl. Lab, USA

* Optics Meets Alzheimer’s Disease: Seeing the Way to a Cure, Lee Goldstein, Harvard Medical School, USA

Technical topic highlights include:

* The use of photon imaging to monitor blood flow in mice after stroke

* Advances in imaging the eye in optical exams and studies of the eye; improved retinal imaging and eye examinations for people with diabetic retinopathy, an eye disorder that strike 40-45 percent of those diagnosed with diabetes

* New methods of producing 3-D images in displays without the need for special glasses

* Prototype system that produces color images in an endoscope, used in examinations of the esophagus and colonoscopies

* A new technique using light to determine blood flow in human brain tumors

* Award Session to recognize industry thought leaders

* “What’s Hot in Optics Now” session highlighting trends across the entire field of optics including biology and medicine, information science, vision and color and optical sciences

* Women in Optical Society of America (WOSA) luncheon with keynote speaker Meg Moulton from the National Coalition of Girls’ Schools on the state of female science education

* “Best of Topicals” session highlighting one stand-out paper from each of OSA’s 2006 meetings

* FiO Special Symposia tribute honoring Emmett Leith, pioneer of practical holography

* Educator’s Programs designed to expose middle and high school science teachers to the world of optics through materials, equipment and training in a hands-on environment with optics professionals. Hands-on activities and demonstrations for children of all ages.

Contact: Keira Shein

Optical Society of America