Month: February 2013

Does cataract surgery increase the risk of vision loss in people with age-related macular degeneration (AMD)? How do people read faces to judge age or fatigue? Which has a larger impact on the “normal” decline of visual function as we age, genetic or environmental factors? These questions are explored in the February issue of Ophthalmology, the journal of the American Academy of Ophthalmology.

Age-Related Eye Disease Study (AREDS) Examines Macular Degeneration Risk Related to Cataract Surgery

Age-related macular degeneration (AMD) and cataract are leading causes of visual impairment in the United States. Both are related to aging, and they share other risk factors, but it has been unclear whether a direct causal link might be involved. Several large epidemiological studies had raised concern that cataract surgery might accelerate AMD progress and threaten vision. To address this concern, Emily Y. Chew, MD, of the National Eye Institute, and colleagues analyzed data for a cohort of participants in the Age-Related Eye Disease Study (AREDS). This cohort is the only large prospective study in which the severity of AMD was documented before and after cataract surgery and which included more than five years of in-depth participant follow-up.

AMD causes changes in the retina, the light-sensitive tissue that focuses images at the back of the eye, and severe AMD leads to loss of central vision. Cataract is cloudiness or opacity in the eye’s lens that interferes with the clear focus of images on the retina.

AREDS researchers concluded there was little evidence that cataract surgery had a negative effect on progression to advanced AMD. “These data may provide some reassurance to patients with AMD who are considering cataract surgery,” Dr. Chew said.

The primary purpose of the AREDS multicenter controlled randomized clinical trial was to assess whether antioxidant and mineral supplements affect progress to advanced AMD and development of cataracts. The cohort study included 4,577 participants (8,050 eyes) aged 55 through 81 at enrollment; it compared the risk of advanced AMD in patients who had cataracts removed versus the risk for those who did not have the surgery. All participants took either antioxidant/mineral supplements or placebos. Study eyes were examined every six months over five or more years. One analysis compared AMD progression in matched pairs of eyes, where one eye had cataract surgery after baseline but before developing advanced AMD, and the paired eye did not have cataract surgery. Matched pairs were determined based on similar risk factors for AMD, assigned antioxidant or placebo treatment, baseline AMD category, person’s age, and other factors. Results of the matched pair analysis and of two other standard analytical models revealed no consistent pattern of accelerated AMD progression after cataract surgery.

Several factors may explain the divergent conclusions reached by AREDS and the earlier studies. The most likely cause would be that earlier studies had unintended biases or confounding variables. Also, techniques of cataract surgery and lens replacement have changed over time, and AREDS participant surgeries were performed more recently than those tracked in the combined-population studies. A significant number of subjects in earlier studies did not have lens replacement after cataract extraction, while AREDS participants were likely to have had ultraviolet-B light blocking lenses inserted, which may have protected their maculae and decreased AMD risk.

Old or Tired? How People Read and Rate Faces

A recent study led by Peter A. D. Rubin, MD, of the University of Tennessee Health Science Center, used eye-tracking methodology to determine how signs of age or fatigue are assessed. Based on their experiences with patients, the researchers hypothesized that the eye area would be especially important. Social psychology research confirms that an attractive appearance enhances everything from a person’s self-esteem to job prospects, and Dr. Rubin’s group wanted to learn which facial features are key to a youthful, lively appearance. They assumed this information would be useful to people considering plastic surgery.

Forty-seven young adults (15 males, 32 females) were recruited from student populations in the Boston area; all passed vision screening tests. In each of two sessions a participant viewed photo images of 48 older individuals on a computer monitor equipped with a camera that analyzed infrared reflection from the eye’s pupil and cornea to determine duration and direction of the gaze. This device, located in the Brandeis University Emotion Laboratory of Derek Issacowitz, PhD, allowed Dr. Rubin’s group to quantitatively measure gaze patterns related to subjective judgments about age and fatigue. The images showed individuals’ faces in neutral expressions, photographed under standardized conditions; the faces were divided into “LookZones” for data analysis. After viewing the image for five seconds, the participant clicked a selection on a rating scale. Age was assessed in the first session and tiredness in the second.

In rating age, participants most often looked at the eye region (46%), the nose (19.2%), the forehead (13.3%), and the region between the eyebrows (10.6%). The eye region was also most frequently selected in rating fatigue (44.7%), followed by the nose (18%), forehead (13.7%) and area between the brows (12.3%). Participants also looked longest at the eye region in both assessment sessions, concentrating on the brow and lower lids. Since the eye region represents just 21% of the area of the face, clearly this area is disproportionately important to such judgments. Overall, results indicated a strong relationship between the way facial regions were used in assessments of age and of fatigue. Because static rather than video images were used, the study did not determine whether attention would be drawn toward the mouth during speech. The researchers note that people from age groups other than young adult might assess facial features differently than this study’s participant group.

“Our results raise the possibility that aesthetic surgery to the eye region may be an efficient, effective intervention to enhance an individual’s attractiveness by reducing how old or tired one appears,” Dr. Rubin said. “Apparently, beauty is not only in the eye of the beholder, but also in the eye of the beholdee,” he quipped. American Society of Plastic Surgery 2007 statistics list eyelid surgery as the fourth most common procedure performed in the United States. Dr. Rubin’s next study will rate age and fatigue perceptions using images of patients before and after cosmetic surgery.

Visual Decline as We Age: Genetics or Environment?

Vision worsens for most of us as we age, even in the absence of eye diseases such as glaucoma or AMD. Elders who have good visual acuity (20/25 vision or better) may have trouble driving at night or adjusting when they move between indoor and outdoor light. Some declines are optic, such as presbyopia, reduced flexibility of the eye’s lens, which causes poorer near vision for many people after age 40. Other declines are neuronal, related to the eye’s ability to send images to the brain. Since crucial functions like reading and memory depend on vision, it is important to understand how “normal” aging occurs and discover what can be done to delay or prevent reduced function. In the first investigation of heredity’s impact on neuronal visual decline, Ruth E. Hogg, PhD, of the University of Melbourne, Australia, and her colleagues used a classic twin study to explore genetic and environmental factors.

Study participants were a cohort of the AMD twin study by the University of Melbourne Centre for Eye Research, comprised of eighty-four twins (42 pairs, 21 identical and 21fraternal) between the ages of 57 and 75 who met study criteria for visual acuity and absence of eye disease. In each person the eye with the best visual acuity (or the right eye if acuity was equal in both eyes) was tested for adaptation to light level changes, for color detection, and for detection of gray tone gradations between image and background, termed contrast sensitivity. Taken together, these tests assess key visual functions needed in daily life. When test results showed that a visual ability declined at about the same age in identical twins, the trait was assumed to be under genetic control, and when the decline occurred at different ages, environmental factors were considered dominant. Results for identical twins and fraternal (non-identical) were compared, and when concordance between scores was higher for identical than for fraternal pairs, genetics was assumed to be the controlling factor.

Genetic factors appear to be strong determinants of sharp visual acuity and color discrimination, functions performed by cone cells pathways in the eye’s retina, the tissue at the back of the eye that converts light into electronic images for relay to the brain. Genetic factors were not strongly correlated with night vision and the ability to adapt to light level changes, which are performed by retinal rod cells, implying that environmental influences are important to those functions. Autopsies and other studies have found that substantially more rod than cone cells are lost as eyes age. The flow of nutrients across the retinal membrane appears to be more important for rod cell than for cone cell function, and it is here that environmental factors-such as smoking, deficient nutrition, excessive sunlight exposure, and inflammation-may influence visual decline. Rod cell deterioration is accepted as a component of both general visual decline and age-related diseases like AMD, the most common cause of visual disability in elders.

“Our results support clinical and research efforts now underway to slow or stop age-related vision decline by modifying lifestyle factors and/or using specific medications,” says Dr. Hogg.

Eds: Full texts of the studies are available from the Academy’s media relations department.

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.

American Academy of Ophthalmology

A number of new treatments to combat sight-stealing diseases like macular degeneration and glaucoma became available in the past decade, but which advances do Eye M.D.s themselves consider most important? The American Academy of Ophthalmology (Academy) put the question to its members in a December 2009 online survey. Of 423 respondents, more than half (51.9 percent) cited Anti-VEGF (vascular endothelial growth factor) treatments for “wet” AMD as most significant. Optical coherence tomography (OCT) was next at 23. 9 percent, followed distantly at 6.6 percent by a glaucoma treatment, Prostamide eye drops. Several other advances-including premium intraocular lenses (IOLs), the Femtosecond laser, gene therapy for Leber’s congenital amaurosis and DSAEK (Descemet’s stripping automated endothelial keratoplasty)-were each cited by about 3 percent of respondents. The survey was conducted and results were made available to all members through the Academy’s comprehensive, web-based education system, the O.N.E. (Ophthalmic News and Education) Network.

Anti-VEGF medications inhibit vascular endothelial growth factor, which can cause abnormal blood vessel growth in the eye’s retina and lead to irreversible vision loss. When this class of drugs was approved by the United States Food and Drug Administration in December 2004, ophthalmologists gained a powerful tool to control wet AMD and prevent vision loss in patients with this previously devastating disease. Research on anti-VEGF treatment for diabetic retinopathy and other serious eye diseases is now underway.

OCT represents a significant improvement over earlier imaging technologies. It can provide cross-sectional images of the macula, topographic images of the optic nerve and measurements of the thickness of the retinal nerve fiber layer. OCT allows ophthalmologists to better diagnose and manage a variety of retinal diseases, as well as glaucoma. It is noninvasive and very fast: a scan can be completed in about one second.

Source
American Academy of Ophthalmology

Imagine a BB gun pellet striking your child’s eye with enough force to knock him to the ground. Sadly, some popular children’s gifts around the holidays can cause serious eye injuries. In recognition of Safe Toys and Celebrations Month, the American Academy of Ophthalmology through its EyeSmart™ campaign reminds parents of the dangers that toys may pose to children’s eyes and offers tips on how to choose safe toys for gift-giving.

A serious eye injury from a toy can ruin your family’s holiday and, more seriously leave your child with permanent vision loss. “I saw an 11 year-old boy who received a BB gun as a gift,” said David Wheeler, MD, clinical correspondent for the American Academy of Ophthalmology. “He was playing with the gun for the first time when his friend accidently shot him square in the eyeball. Neither of the boys were wearing protective eyewear. Unfortunately, my patient suffered extreme damage and vision loss, and even after going through several surgeries, he was left legally blind in that eye.”

Children receive all types of potentially unsafe presents during the holidays, including BB guns, darts, pellet guns and paintball guns. According to the Consumer Product Safety Commission, there were more than 235,000 toy-related injuries treated in U.S. emergency rooms in 2008; nearly three quarters of those injured were children under age 15.

With so many toys being recalled or having the potential to cause injuries, many parents are wondering what toys are safe. “It’s important for parents to choose a toy that is appropriate for their child’s age, abilities, and the parents’ willingness to supervise use of the toy,” says Dr. Wheeler. Sports equipment, a popular gift, should also include the protective eyewear. Sports-related eye injuries can cause permanent vision loss and account for about 40,000 eye injuries annually.

Tips for a safe holiday season:

– Avoid purchasing toys with sharp, protruding or projectile parts.

– Make sure children have appropriate supervision when playing with potentially hazardous toys or games that could cause injury.

– If you plan to give sports equipment, provide appropriate protective eyewear with polycarbonate lenses. Check with your local Eye M.D. to learn about protective gear recommended for your child’s sport.

– Check labels for age recommendations and be sure to select gifts that are appropriate for a child’s age and maturity.

– Keep toys that are made for older children away from younger children.

– The branches and needles of Christmas trees can be hazardous to the eyes, so be especially careful when untying your tree. The branches can burst forward, hitting and injuring your eyes. Glass ornaments should be hung out of a child’s reach to avoid potential injury.

For more information about eye safety and eye injuries, go here.

Source
American Academy of Ophthalmology

Jeffrey Bigham, assistant professor of computer science at the University of Rochester has been named one of the top 35 researchers in the world under the age of 35 by Technology Review, MIT’s magazine on science and technology. Bigham will be featured along with the other 34 finalists, chosen from more than 300 nominees, in the magazine’s Sept./Oct. issue, and will be recognized at MIT’s Emerging Technologies Conference in Sept.

Bigham, who joined the University this summer, studies human-computer interactions to help people more effectively access useful information. His current research focuses on empowering people with blindness to collaboratively improve the accessibility of the internet without relying on others. His program TrailBlazer is a browser-based tool that monitors the web usage of blind and sighted users in order to recommend the web content a user is likely to want at a given moment.

“We’re very proud to have Jeffrey with us,” says Henry Kautz, chair of the Department of Computer Science. “His focus on making the web more accessible to people with blindness is a terrific example of how we can use the computer science to make life better for everyone.”

In addition to Trailblazer, Bigham is working on a software tool called WebAnywhere, which is a web-based screen reader that lets a person with blindness access the web from any computer without installing special screen-reading software. WebAnywhere is currently utilized by nearly 1,000 users each week across the world, many of whom would not otherwise have access to internet content. Bigham’s project is open source, which means anyone can improve on it. A team in China recently created a Cantonese version of WebAnywhere, illustrating its global reach.

Bigham is also looking at ways to extract information from the “hidden web” – databases and similar caches of non-linked information that are not normally indexed by search engines. Before coming to Rochester, Bigham earned his bachelor’s degree from Princeton in 2003, and his doctorate from the University of Washington in 2009.

Source:
Jonathan Sherwood

University of Rochester

Almost one-third of older Americans diagnosed with primary open angle glaucoma (POAG) are not treated medically or surgically for the condition according to a study presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Fort Lauderdale, Fla.

The study is the first investigation of glaucoma-therapy use in the U.S. to utilize longitudinal data from a nationally representative sample of Medicare patients. The researchers examined trends in glaucoma medication use and surgeries among adults aged 65 and older by analyzing data collected from 1992 through 2002 as part of the Medicare Current Beneficiary Survey (MCBS). A total of 3,020 MCBS participants were identified as having diagnosed POAG.

A major finding of this study is that, on average, 30 percent of Medicare beneficiaries with POAG did not use any glaucoma medication and did not undergo any type of glaucoma-related surgery in a given study year. Among those patients who did use glaucoma-related medications, the classes of prescription eye drops used changed over the study period, with a substantial increase in the use of prostaglandin analogues.

Lead researcher Joshua D. Stein, MD, MS, from Duke University in Durham, NC, said, “We’ve known that consistent use of effective medical therapies reduces patients’ risk for blindness due to glaucoma yet we found that many patients are not benefiting from the availability of these increasingly effective therapies. An important lesson emerges from this research: We need to do a better job of educating patients and their physicians, as well as health policymakers and insurance-industry leaders, of the benefits of consistent glaucoma therapy.” He concludes, “If we do not learn this lesson, glaucoma will continue to be a leading cause of blindness in older populations.”

Established in 1928, ARVO is a membership organization of more than 11,700 eye and vision researchers from over 70 countries. The Association encourages and assists its members and others in research, training, publication and dissemination of knowledge in vision and ophthalmology. ARVO’s headquarters are located in Rockville, Md. For more information, logon to arvo/.

Contact: Karen Colson

Association for Research in Vision and Ophthalmology

One method of identifying which organisms are involved in cases of corneal eye infections is to look at the cultures of contact lenses, according to an article in Archives of Ophthalmology (JAMA/Archives), September issue.

The authors of the articles say “Contact lens wear is associated with a significant risk of microbial keratitis [corneal eye infection] leading to severe sight-threatening complications. Microbial keratitis has been seen in all types of lenses, including rigid gas-permeable lenses, hard or poly-methylmethacrylate lenses and high-and-low-oxygen transmissibility soft lenses, as well as with all modes of wear, including daily wear, extended wear, therapeutic wear and continuous wear.”

Soft contact lenses are more likely to trigger infections than other types of lenses, the authors write.

Sujata Das, M.S., F.R.C.S., of the Center for Eye Research Australia, University of Melbourne and Royal Victorian Eye and Ear Hospital, Melbourne, Australia, and colleagues looked at the records of 49 patients who suffered from contact lens-related microbial keratitis. Their average age was 34. The study looked at the period January 2001 – December 2004. Their aim was to see what link there was between cultures of contact lenses and cultures of corneal scrapings. They factored in such variables as sex, symptoms, age, results and predisposition.

Of the 49 patients (98 eyes) there were 50 eyes with microbial keratitis. 34% (17) of corneal scrapings and 70% (35) of the contact lenses had organisms breeding on them. As far as 13 of the eyes were concerned, the organisms that were growing in the cultures taken from the contact lenses and corneal scraping were identical. Only two eyes had different organisms from the contact lenses. In just two eyes were corneal scrapings found to be culture positive, wrote the authors.

The most common organism found in the corneal scrapings as well as the contact lenses was Serratia Marcescens.

The writers conclude “Our study highlights the fact that contact lens culture may help in identification of the causative organism in many cases of contact lens-related microbial keratitis. Also, contact lens culture may give a clue regarding the identity of the causative organism in situations in which the corneal scraping is culture negative and may help in choosing the appropriate antimicrobial agent.”

“Association Between Cultures of Contact Lens and Corneal Scraping in Contact Lens-Related Microbial Keratitis”
Sujata Das, MS, FRCS(Glasg); Harsha Sheorey, MD, FRCPA; Hugh R. Taylor, AC, MD, FRANZCO; Rasik B. Vajpayee, MS, FRCS(Edin), FRANZCO
Arch Ophthalmol. 2007;125:1182-1185.
Click here to view article online

Fredrick Khachik, Ph.D., a senior research scientist in the Department of Chemistry and Biochemistry at the University of Maryland, College Park, has been chosen to receive a 2009 Astellas USA Foundation Award. The award, administered by the American Chemical Society, is given to individuals who have made significant scientific research contributions that improve public health through their work in the chemical and related sciences.

The award includes a $30,000 grant to support his continuing research efforts.

Khachik’s research focused on dietary compounds called carotenoids found in fruits and vegetables. These compounds accumulate in the retina and can help prevent age-related macular degeneration (AMD), which causes a loss of central vision. Khachik developed a process to isolate and purify two of these carotenoids, lutein and zeaxanthin, from marigold flowers and plants. Prior to this innovation, the biological properties of these two compounds could not be investigated in clinical trials. The National Eye Institute is currently conducting a multi-center, randomized clinical trial known as: “The Age-Related Eye Disease Study 2 (AREDS2)” to assess the effects of oral supplementation of lutein and zeaxanthin on the progression to AMD. (areds2).

Khachik received his B.S. degree from Pars College in Iran and earned his M.S. and Ph.D. degrees in organic chemistry from the University of Manchester Institute of Science and Technology in the United Kingdom. He has been affiliated with the University of Maryland since 1997.

Source: Doug Dollemore

American Chemical Society

Dr. Richer, speaking at his 4th annual Nutrition & The Eye conference, April 16-17, hosted by the College of Optometry at the University of Missouri in St. Louis, says molecular medicine is beginning to provide hope for patients with declining sight when all other therapies have been exhausted. “These nutritional molecules have begun to be rigorously studied around the world in cardiology, cancer research and some human studies”, Dr Richer reported.

Dr. Richer has now accumulated a growing number of otherwise hopeless cases that retina specialists and other ophthalmologists referred to his center. These low-cost preventive molecular medicine approaches have worked without fail so far, he says. Dr. Richer presented six separate cases where molecular medicine sometimes improved functional vision within days, which was unexpected.

A recent case, says Dr. Richer, is an 88-year old woman with macular degeneration, an age-related eye disorder that robs seniors of their central vision. Retinal specialists had said that she was beyond any help offered by conventional medicines and surgery. Employing a molecular medicine regimen, this hospitalized woman regained her ability to see faces, read a menu and visualize her handwriting in just four days. Her vision improvement was in both eyes says Dr. Richer. “A second 88-year old patient, this time with “dry” macular degeneration, took 10 weeks to see clinical improvement, but by 20 weeks the retina appeared to return to a more youthful appearance with 20/20 vision.”

Dr. Richer says, typically in the cases he has monitored, blind spots (called scotomas) disappear, time to recover from bright light (glare recovery test) is reduced, and contrast vision (shades of grey) as well as visual acuity (ability to see letters on a chart) generally improve within 3-6 weeks on a molecular medicine regimen that provides small molecules that bind to (chelate) to minerals such as copper, iron and calcium.

In recent months a growing body of scientific studies point to the age-related over-accumulation of these minerals as an underlying cause of eye problems in the aged.

Dr. Richer selected a nutriceutical mixture of vitamins and small molecules (Longevinex®) extracted from herbs and vitamins to produce these rapid improvements in functional vision because of its extensive testing and proven ability to favorably alter genes in a superior manner to other available nutriceuticals.

He says the human eye apparently has untapped regenerative capacity that can be activated with molecules found in nature. There is a growing body of science which points to regeneration of tissue via the use of molecular medicine to promote the survival of endogenously-produced stem cells. Dr. Richer believes this is what is actually happening in these cases, “and if scientifically proven, this approach has obvious advantages when used alone or in conjunction with injected stem cells or organ transplants”, he emphasizes.

Dr. Richer says age-related eye problems may not be inevitably progressive. There is new-found hope for recovery of lost vision, regardless of the age of the patients.

Dr. Richer has no financial interest in the products used in his investigations.

Source:
Stuart Richer O.D., Ph.D.
Resveratrol Partners LLC, dba LONGEVINEX

Myopia (nearsightedness) is the most common eye disorder in the world and becoming more common, yet little is known about its genetic underpinnings.

Scientists at Duke University Medical Center, in conjunction with several other groups, have uncovered a gene associated with myopia in Caucasian people from several different regions, including Dutch, British and Australian subjects.

Their work was published in Nature Genetics online on Sunday, Sept. 12.

Myopia happens when the focal point of an image falls just short of the retina at the rear of the eye, causing blurred distance vision.

Often the discovery of a gene still means that many years could pass before a treatment becomes available. However, gene therapies are already working well in some eye conditions, and myopia may be a good candidate condition for gene repair.

“The eye is already an organ of choice for gene therapy, for example, because the eye’s small volume and self-contained area allow the therapy to remain inside the eye in a concentrated volume,” said lead author Terri Young, M.D., professor of ophthalmology, pediatrics, and medicine, and a researcher in the Center for Human Genetics at Duke. “In addition, the eye’s accessibility lets clinicians observe the effects of treatment over time with noninvasive methods that can illuminate and test the retina and other eye structures.”

While many cases of myopia are mild, about 2 to 3 percent are pathological cases with retinal detachment, premature glaucoma, macular bleeding, and glaucoma leading eventually to blindness, said Young, who has spent over a decade studying the severe form of myopia.

Up to 80 percent of people in Singapore have myopia, while about one in three Americans has the condition. Countries with a high prevalence of nearsightedness have a hard time finding fighter pilots, to give one example of how myopia affects a population.

There is an antidote for the condition. “People need to go outside and look to the horizon,” Young said. “Today’s near work forces our eyes to constantly be in tension to focus on near objects – reading papers and watching monitors. We also watch TV, work in cities with high buildings, drive in heavy traffic, and generally have fewer chances for distant views, especially in urban areas. These factors affect children with developing vision, as well as many adults.”

Working with a large group of researchers, Young, co-lead author Pirro Hysi of the Department of Twin Research and Genetic Epidemiology of Kings College in London, and colleagues found several distinct spellings of DNA code near the RASGRF1 gene that had a strong association with focusing errors in vision. These findings were validated in six other Caucasian adult groups in a total of 13,414 subjects.

“Because RASGRF1 is highly expressed in neurons and the retina, it is crucial to retinal function and visual memory consolidation,” Young said.

When the scientists created mice that were missing the correct gene, these mice showed changes in their eye lenses.

“This was biologically convincing,” Young said. “The RASGRF1 provides a novel molecular mechanism to study so that we can work to prevent the most common cause of visual impairment.”

Young has also led a team that found a different gene — CTNDD2 — related to myopia in Chinese and Japanese populations. That work included researchers from the Duke Center for Human Genetics, the Duke-National University of Singapore (NUS) Graduate Medical School in Singapore, and the National University of Singapore. In many Asian countries, a majority of people have myopia.

Notes:
The study was funded by the National Institutes of Health (NIH) National Eye Institute, the NIH Center for Inherited Disease Research, the Wellcome Trust, the EU MyEuropia Marie Curie Research Training Network, and Guide Dogs for the Blind Association, the European Community’s Seventh Framework Programme /grant agreement, the ENGAGE project grant agreement and the FP-5 GenomEUtwin Project. The study also received support from the National Institute for Health Research (NIHR) comprehensive Biomedical Research Centre award to Guy’s & St Thomas’ NHS Foundation Trust, in partnership with King’s College, London. The project received support from a Biotechnology and Biological Sciences Research Council project grant.

Other authors include scientists from the Lions Eye Institute, University of Western Australia, Centre for Ophthalmology and Visual Science in Perth, Australia; the Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital in Australia; the University of Salamanca, CIC-IBMCC (CSIC-USAL) in Salamanca, Spain; the Departments of Ophthalmology and Epidemiology, Erasmus Medical Center, in Rotterdam, the Netherlands; Genetics and Population Health, Queensland Institute of Medical Research, in Brisbane, Australia; the Department of Psychiatry, University of Hong Kong, China; and the MRC Centre of Epidemiology for Child Health, Institute of Child Health, University College in London.

Source:
Mary Jane Gore
Duke University Medical Center

Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH) announced it has initiated a Phase 2 program with AzaSite® (azithromycin ophthalmic solution) 1% to pursue a potential indication for the treatment of blepharitis, an ocular disease characterized by inflammation of the eyelids. AzaSite is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis.

Inspire has initiated two Phase 2 clinical trials. One trial is a randomized, placebo-controlled, multi-center trial at approximately 30 clinical sites evaluating the safety and efficacy of two weeks of treatment with AzaSite compared to placebo in approximately 300 subjects with blepharitis (Trial 044-101). The second trial is a randomized, placebo-controlled, multi-center trial at approximately 30 clinical sites evaluating the safety and efficacy of four weeks of treatment with AzaSite compared to placebo in approximately 300 subjects with blepharitis (Trial 044-102). The trials will evaluate various signs and symptoms of blepharitis as well as safety and tolerability. The results from each trial are expected in the first half of 2010. Esen Akpek, M.D., Associate Professor of Ophthalmology and Director, Ocular Surface Diseases and Dry Eye Clinic, Wilmer Eye Institute, is the lead principal investigator for Trial 044-101. Christopher J. Rapuano, M.D., Professor of Ophthalmology, Jefferson Medical College of Thomas Jefferson University and Co-Director, Cornea Service, Co-Chief, Refractive Surgery Department, Wills Eye Institute, is the lead principal investigator for Trial 044-102.

Dr. Rapuano stated, “Blepharitis is a common yet under-treated ocular disease that causes significant symptoms in many patients and represents an important unmet medical need. Currently, there are no FDA-approved prescription products indicated for the treatment of blepharitis and patients have sub-optimal options available to attempt to manage this chronic disease.”

Kim Brazzell, Ph.D., Executive Vice President and Head, Ophthalmology Business at Inspire, stated, “The Phase 4 results we have generated to date suggest that AzaSite could be an effective treatment for blepharitis and the goal of the Phase 2 program is to more fully understand this potential by studying AzaSite in larger Phase 2 placebo-controlled trials.”

About Blepharitis

Blepharitis is an ocular disease characterized by inflammation of the eyelids, which is often secondary to infection. Blepharitis often involves significant patient discomfort associated with ocular surface inflammation, chronic ocular irritation, unstable tear film and damage to the ocular surface. Inspire’s market research and input from eye care specialists suggests that blepharitis is an under-diagnosed and under-treated condition, with no prescription pharmaceutical products approved for this indication.

About AzaSite®

AzaSite (azithromycin ophthalmic solution) 1% is a prescription medicine approved by the U.S. Food and Drug Administration for the treatment of bacterial conjunctivitis in adults and children 1 year of age and older. AzaSite is for topical ophthalmic use only. In clinical trials, the most frequently reported ocular adverse event was eye irritation, which occurred in 1% – 2% of patients. Please see full Prescribing Information for AzaSite at azasite. Inspire is pursuing an additional potential indication for AzaSite for the treatment of blepharitis.

Source
Inspire

View drug information on AzaSite.