Eye Care Medical Blog

Presently keratoconus is treated through eyeglasses, hard contact lenses, and a newer treatment, INTACS plastic rings inserted into the mid layer of the cornea to flatten it, changing the shape and location of the cone. In 15-20% of the cases, cornea transplant surgery is necessary. The Cornea Research Foundation of America is one of 9 sites in the U.S. currently participating in a new clinical research investigation to study the benefits of corneal collagen cross-linking (CXL) in subjects with progressive keratoconus and corneal ectasia after prior refractive surgery. These studies are the first in the U.S. of CXL designed to assess the safety and effectiveness of CXL for slowing the progression of both of these conditions.

“Because the FDA usually requires data from two separate studies before approving a new drug or device, we are conducting two cross-linking studies: one is for the treatment of keratoconus and the other is for treatment of post-refractive ectasia, a rare complication of refractive surgery,” says Marianne Price, executive director of the Cornea Research Foundation of America.

The FDA permitted study is sponsored by Swiss-based Peschke Meditrade GmbH. Corneal collagen cross-linking is a procedure that involves administering riboflavin and UVA in carefully selected parameters that strengthen the front layers of the cornea and avoid damage to the back of the eye. The riboflavin and UVA light source that is used for CXL are both investigational in the United States and are not yet approved by the FDA.

The Foundation started the collagen cross-linking study in January 2008. The FDA has given permission for enrollment of 160 patients into each study. People interested in more information about the study or participating in the study can contact the Cornea Research Foundation of America. Subjects may be eligible for the study if they have the following in one or both eyes, or are:

— 18 years of age or older

— Have been diagnosed with progressive keratoconus or have had previous vision correction surgery and now have corneal ectasia

— Vision with contact lenses or glasses is worse than 20/20

— Corneal thickness greater than 300 microns at the thinnest point

— If you are female, you cannot be pregnant

— Can leave contact lenses out for at least 3 months in the eye to be treated

— If you have keratoconus, you cannot have had previous corneal surgery or Intacs

— If you have keratoconus, it must have gotten worse in the last two years based on your previous eye exams. You will need to contact your eye doctor or allow us to contact your eye doctor to get your eye exam records for your vision measurements, corneal maps (topography) and contact lens or glasses prescriptions.

Expert Source: Dr. Marianne Price, executive director of the Cornea Research Foundation of America. Dr. Price is a sought after speaker and published author, a member of the American Academy of Ophthalmology, the Association for Research in Vision and Ophthalmology, the American Society of Cataract & Refractive Surgery, and Ophthalmic Women Leaders. Dr. Price holds a bachelor’s degree in engineering science from the University of Notre Dame and both an MBA in finance and a doctorate in medical and molecular genetics from Indiana University.

Cornea Research Foundation of America
9002 N Meridian St., Ste. 212
Indianapolis
IN 46260
United States
cornea

Onchocerciasis is an infection caused by Onchocerca volvulus, a parasite nematode worm transmitted to humans by a species of black fly of the Simulium genus whose larvae develop in fast-flowing rivers. Infected subjects suffer not only from severe skin lesions but also eye damage that can lead to irreversible loss of sight, hence the name ‘river blindness’. A huge majority — 99% — of the 37 million people infected by the parasite live in SubSaharan Africa. Ivermectin, a medicine capable of killing the parasite embryos (the microfilariae) circulating in the organism of patients and temporarily interrupting the nematode’s reproduction, is the only treatment used for onchocerciasis control. Since 1995, the African Programme for Onchocerciasis Control (APOC) has been covering 19 of the continent’s 28 countries hit by the disease. Access to this treatment is possible for 70 million people and has significantly diminished the onchocerciasis-induced morbidity. However, the doubling of cases of infection in certain communities of Ghana between 2000 and 2005, in spite of annual treatments, created fear of the emergence of ivermectin-resistant strains. Such apprehension appears particularly justified in that a high degree of therapeutic cover is achieved during mass distribution campaigns and hence only a tiny part of the parasite population targeted remains unexposed to drug treatment pressure.

Since 1994, a team of IRD researchers, working jointly with Cameroon researchers and others from McGill University of Montreal, has been monitoring a cohort of Cameroon patients benefiting from repeated treatments with ivermectin. Regular parasite sampling from these subjects was performed over a 13-year period in order to determine the changes in the genetic structure of Onchocerca volvulus populations. Each occasion involved measurement of the genotype frequency of heterozygotes and homozygotes for the gene coding ??-tubulin, a protein involved in the organization of the parasite’s cells. The team focused on this particular gene because it acts as a marker of resistance to ivermectin in other nematode species parasitic on cattle. As a control, they monitored the changes in genotype frequency of two other genes, known for their high evolutionary stability over time. The proportion of homozygotes and heterozygotes for these two genes remained stable throughout the investigation, but the situation was completely different for the ??-tubulin gene. Between 1994 and 1998, the percentage of parasites showing a genotype homozygous for this gene fell from 79 to 31% in subjects receiving quarterly treatment with ivermectin. At the same time, the proportion of heterozygous genotypes changed in the opposite sense, rising from 21 to 69%. These results could be the sign of adaptation of nematode worm populations to repeated treatments using this drug. The research team inferred that the parasites showing a genotype homozygous for ??-tubulin are more susceptible to it. As courses of treatment progressed, they would therefore gradually disappear, to the benefit of the more resistant heterozygous strains. Ivermectin’s effect on microfilariae, other than its direct one, is to prevent them from leaving the uterus of adult worms, for several months after treatment: this is its embryostatic effect. Post-treatment, there were more microfilariae in the uterus of homozygous female parasites than in those of heterozygous females. This could mean that, in the latter, the microfilariae succeed in leaving the uterus, as they usually do in the absence of treatment, and therefore that the embryostatic effect of ivermectin would be diminished. Contrary to the effect anticipated, the repeated exposure to treatments could in this way select those worms more able to keep up the production of new generations. Nevertheless, the drug’s direct action on the microfilariae appeared not to change, and hence, for the moment, there is no reason to call into question the current control strategy against the disease based on annual treatments with ivermectin.

Affirmation of the results requires further investigations1, starting from new cohorts subjects infected by Onchocerca volvulus who have not yet been treated with ivermectin. This type of approach should bring more information on the risks of the parasite’s resistance to this drug. If such risks were confirmed, then the whole onchocerciasis control strategy would probably have to be revised. Nevertheless, for many years to come, ivermectin could well remain the sole drug applicable for mass treatment in measures to control river blindness.

Gr?�gory Fl?�chet – DIC

1. A study coordinated by the IRD and financed by the French Agence nationale de la recherche (ANR), aiming to find more extensive information on possible resistance of the onchocerciasis parasite to ivermectin, is currently being conducted in Cameroon jointly with a team from INRA, research scientists from the universities of Yaound?� I and Buea (Cameroon), the Cameroon Ministry of Public Health, McGill University of Montreal (Canada) and Imperial College London (United Kingdom).

Source: Gregory Flechet

Institut de Recherche Pour le D?�veloppement

Like many diseases, causes for age-related macular degeneration (AMD) can be categorized as either “nature” or “nurture”. Researchers think these factors, when used in the proper model, can be strong predictors of the disease.

AMD is the leading cause of vision loss in Americans 60 years of age and older.

A study published in the Association for Research in Vision and Ophthalmology’s peer-reviewed Investigative Ophthalmolgy & Visual Science (“Prediction Model for Prevalence and Incidence of Advanced Age-Related Macular Degeneration Based on Genetic, Demographic and Environmental Variables”) shows that multiple genetic, ocular and environmental factors, including six genetic variants, age, smoking and body mass index heavily contribute to the incidence of AMD. Because all of these factors are related to AMD, they were combined and used to develop a predictive and possibly diagnostic model.

“The determinants of the model can be assessed by completing a questionnaire and taking a blood test, and it is a tool which could be used to help guide prevention and treatments” said lead author and principal investigator, Johanna M. Seddon, MD, ScM, Professor of Ophthalmology at Tufts University School of Medicine and Director of the Ophthalmic Epidemiology and Genetics Service at Tufts Medical Center. “Such information may be also be useful for screening those at high risk of AMD due to a positive family history or having signs of early or intermediate disease even among those with normal vision,” the study says.

Over 1,400 individuals in the Age-Related Eye Disease Study (AREDS) with an average follow-up time of 6.3 years were evaluated, and genetic specimens were genotyped in the collaborator’s lab in Boston. Both prevalence and development of advanced dry and wet AMD over the course of the study were included in the analyses. Researchers found all tested variables to be independently associated with AMD. The predictive power of the variables in the formula was very high, and the probability that the risk score based on the group of factors in that model for a progressor was higher than the corresponding risk score for a random non-progressor within the same 10 year age group was 83%.

Their research also shows that although AMD has a strong genetic component, healthy behaviors can modify your genetic susceptibility. For example, among individuals with one genotype, the homozygous C3 risk genotype, the likelihood of progression to the advanced form of AMD increased from about three-fold for nonsmokers to nearly 10-fold for smokers.

“Our algorithm could help with the selection of study participants for treatment trials and could one day enable doctors to choose the most efficacious treatment for individual patients,” Dr. Seddon said. “It also gives any older person concerned about AMD, or any patient with early stages or a family history of AMD, even more incentive to avoid risk factors such as smoking and excessive weight.”

Investigative Ophthalmology & Visual Science is a peer-reviewed publication of the Association for Research in Vision and Ophthalmology (ARVO).

ARVO is the largest eye and vision research organization in the world. Members include more than 12,000 eye and vision researchers from 73 countries. The Association encourages and assists research, training, publication and dissemination of knowledge in vision and ophthalmology.

Source: Association for Research in Vision and Ophthalmology

Increasing stiffness of the aging eye may make older adults more susceptible to eye damage following trauma, according
to research at Wake Forest-Virginia Tech School of Biomedical Engineering and Sciences.

“The gradual change in lens stiffness during a person’s lifetime leads to a lens that is four times stiffer than at birth,
and this has implications for the likelihood of eye injury,” said Joel D. Stitzel, Ph.D., of the Virginia Tech-Wake Forest
Center for Injury Biomechanics, and three colleagues, writing in the June issue of Archives of Ophthalmology.

Using a computer model of the eye, Stitzel and colleagues investigated possible injury mechanisms in the eyes of elderly
individuals and the effects of lens stiffness on injury prediction by the model. The new data document that the risk of
certain types of eye injury increases with age.

“General testing of the mechanical characteristics of the entire lens suggests that aging of the human lens is associated
with a progressive loss of mechanical strength,” Stitzel said. “As stiffness of the lens increases over time, the amount of
deformation that the lens can withstand without damage or dislocation decreases. This can result in an increased risk of eye
injury with age, not only to the lens itself but also to other internal components of the eye, resulting in increased risk of
tearing of internal structures of the eye and bleeding.” He added, “The effect is like brittle bones in some elderly people
and those with osteoporosis: just as these people are more prone to breaking bones, increased lens stiffness can result in
greater risk of injury to the eye.”

This evidence led to several recommendations.

“The data indicate that all people, especially elderly individuals, should use safety systems, such as seat belts, while
driving a car and sit as far back from the air bag as is comfortable,” said Stitzel, assistant professor of biomedical
engineering at Wake Forest University School of Medicine, a part of Wake Forest University Baptist Medical Center. And the
researchers called for design modifications to reduce the risk that a deploying air bag in an automobile will contact the
eye.

People who wear glasses “should be sure that they are fitted with impact-resistant polycarbonate lenses,” he said. “Those in
sports or work environments requiring protective lenses should wear them.”

Stitzel and his colleagues have been working on the computer simulation model for several years and already have reported
that the model tracks the actual results of a series of experiments in which foam particles, BBs and baseballs strike the
human eye. The model predicts when the globe of the eye will rupture from high-speed blunt trauma.

In an accompanying editorial, Paul F. Vinger, M.D., of Concord, Mass., said the Virginia Tech-Wake Forest center’s project to
create the computer simulation “is a formidable undertaking that is bound to change the course of eye trauma research.”

He said that when the model predictions were compared with actual results, there was “excellent correlation between the
calculated and experimental results.”

The new research “extends this model to study the effects of increasing lens stiffness due to aging on the probability of
suffering eye injuries in a car accident, such as being hit in the eye with the steering wheel, an airbag or a foam
particle,” Vinger said in the editorial.

Contact: Robert Conn
rconnwfubmc.edu
336-716-4587
Wake Forest University Baptist Medical Center
wfubmc.edu

Precision tinted lenses have been used widely to reduce visual perceptual distortions in poor readers, and are increasingly used for migraine sufferers, but until now the science behind these effects has been unclear. Now research published in the journal Cephalalgia, published by SAGE, uses functional magnetic resonance imaging (fMRI) for the first time to suggest a neurological basis for these visual remedies.

The new research shows how coloured glasses tuned to each migraine sufferer work by normalizing activity in the brain. The researchers saw specific abnormal brain activity (known as hyperactivation) when migraine sufferers saw intense patterns. The tinted lenses considerably reduced the effect.

Jie Huang along with colleagues from Michigan State University and the University of Michigan, US, and the University of Essex, UK, homed in on specific visual stimuli known to trigger migraines. These patterns, high contrast stripes or ‘gratings,’ can give the illusion of shape, colour and movement. These not only trigger migraines but also may cause seizures in those with photosensitive epilepsy.

Before the brain imaging took place, participants were tested and prescribed precision ophthalmic tints (POTs) with an Intuitive Colorimeter. Previous studies have suggested that some 42% of migraine with aura sufferers saw their migraine frequency halved on days when they wore POTs. The researchers used the colorimeter to illuminate text with coloured light, manipulating hue and saturation at constant luminance. For each test participant this gave an optimal hue and saturation (chromaticity) of light that led to the greatest comfort, reducing perceptual distortion. The test subjects then viewed stressful striped patterns illuminated with their optimal coloured light settings to screen for efficacy. The researchers used these readings to generate both effective POTs for each migraine sufferer and also two other pairs of grey and coloured lenses with slightly different properties as controls. 11 patients who frequently suffered from migraine enrolled in the fMRI study. Each patient was paired with a migraine-free control, who was also tested with that patient’s three sets of lenses.

Once in the fMRI machine, the researchers exposed subjects to a range of striped patterns – these had varying likelihood of triggering distortion and discomfort. This study aimed to investigate the effect of the POTs on the cortical activation induced by the stressful pattern in each of the visual areas of the brain. Although patients reported some relief using all of the lenses (by around 40%), the POT lenses had a significant effect when viewing the stressful stripes (70% discomfort reduction). Both control and migraine patients responded similarly to the non-stressful stripe patterns, and in these cases all three lenses made no difference to the result. The POTs specifically suppressed cortical activation for migraine sufferers in visual area V2 of the occipital cortex of the brain, and this POT-suppressed cortical activation was also extended to the other extra-striate visual areas V3, V3A, and V4

“The reduced cortical activation in V2 by the POTs may have been responsible for the POT-induced suppression of the illusions and distortions, considering that V2 neurons but not V1 neurons in macaque monkeys respond to illusory contour stimuli,” Huang suggests.

The cause of these responses to specific visual stimuli is likely to differ from the photophobia (light sensitivity) migraine sufferers often report during an attack. Going forward, the authors suggest that the specific characteristic of the cortical activation in the extra-striate visual areas they recorded could provide a potential biomarker for identifying those migraine patients suffering cortical hyperactivation. This biomarker could prove useful not only for further evaluation of POTs but also for studying the effectiveness of drugs to prevent migraine.

Notes:

fMRI evidence that precision ophthalmic tints reduce cortical hyperactivation in migraine by Jie Huang, Xiaopeng Zong, Arnold Wilkins, Brian Jenkins, Andrea Bozoki, Yue Cao is published today (26 May, 2011) in the journal Cephalalgia. The article will be free to read for a limited period here.

Source:
Jayne Fairley

SAGE Publications

Drug delivery company pSivida Corp (NASDAQ:PSDV)(ASX:PVA) today announced that a clinical trial has begun using its MedidurTM delivery technology to treat a form of dry-Age related Macular Degeneration (dry-AMD).

Medidur is a tiny intravitreal insert designed to be administered by an eye care professional, using a proprietary 25-gauge inserter in a minimally invasive, outpatient procedure.

This application of Medidur technology has been licensed to Alimera Sciences and is in pivotal Phase III clinical trials for the treatment of diabetic macular edema (DME), a potentially blinding disease that affects over 1,000,000 people in the US. The Phase III clinical trials were fully enrolled over a year ago with preliminary efficacy and safety results expected in approximately one year. If approved by the FDA, Alimera will market the product under the name IluvienTM.

The new study is an investigator sponsored pilot study designed to assess the saf! ety and efficacy of Iluvien in patients with bilateral geograp! hic atro phy (GA) secondary to dry-AMD and will compare two doses of Iluvien with a sham injection.

“The impetus for this study was the results of experiments conducted in two animal models of retinal degenerations. In both of these models, a miniaturized version of Iluvien demonstrated protective effects on the spontaneous degeneration which occurs in these animals,” said Raymond Iezzi, M.D., of Kresge Eye Institute, Wayne State University School of Medicine. “These results were considered compelling enough to warrant a human study, especially for a condition for which there is no approved treatment,” added Dr. Iezzi.

Dr Paul Ashton, Managing Director of pSivida Corp. said, “We are pleased that another application of our Medidur technology has now entered clinical trials.”

About PSIVIDA LIMITED

pSivida is a drug delivery company committed to the biomedical sector, with a primary focus on ophthalmology and oncology. pSivida has two product! s approved by the Food and Drug Administration (FDA): Retisert(R) to treat uveitis and Vitrasert(R) for treating AIDS-related cytomegalovirus (CMV) retinitis.

pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has one product in fully recruited Phase III clinical trials: Iluvien(TM), which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.

psivida

Mayo Clinic researchers, as part of a nine-site study, helped discover the best of three currently-used treatments for convergence insufficiency in children. Convergence refers to the natural ability of the eyes to focus and align while viewing objects up close. Children with convergence insufficiency tend to have blurred or double vision or headaches and corresponding issues in reading and concentrating, which ultimately impact learning. The findings, published today in the journal Archives of Ophthalmology, show children improve faster with structured therapy sessions in a doctor’s office, with reinforcement eye exercises at home.

“This is good news for children and parents experiencing this fairly common condition,” says Brian Mohney, M.D., Mayo Clinic ophthalmologist and lead investigator for Mayo in the study. “Three different approaches were being used across the country and no one knew for certain which worked best. Now that’s settled. And only 12 weeks of treatment were necessary to demonstrate improvement.”

How they did it

The researchers followed 221 children nationally, ages 9 to 17, divided into four study groups, two of which received only home-based therapies. One group did simple daily exercises for 15 minutes, trying to focus on a moving pencil. A second home-based group performed a shorter version of the pencil exercise and a series of computer-based exercises using special software. A third group did an hour of supervised therapy in a clinical office each week along with 15 minutes of prescribed exercises at home five days a week. The fourth group, the placebo or control group, did office and home exercises designed to look like real therapy but that had no effect. Follow-up exams were held after the fourth and eighth weeks and at the end of the 12-week study.

Significance of the findings

Children in all three treatment groups experienced improvement, though it’s not clear from the research whether any improvement in the home groups was due to a placebo effect. About 75 percent of the children who had weekly office-based therapy coupled with 15 minutes of at-home exercise five days a week experienced either normalization (full correction) of their vision in 12 weeks or saw marked improvements, compared to roughly 40 percent in the two home treatment groups. Researchers say that the lower cost of home therapy may be a factor in its popularity, but they point to the high percentage of normalized vision in the office-based sample after 12 weeks as an indicator of quality outcome in the shortest period of time.

The National Eye Institute, part of the National Institutes of Health, sponsored the study. Others involved in the research from Mayo Clinic were Jonathan Holmes, M.D.; Melissa Rice, O.D.; Virginia Karlsson; Becky Nielsen; Jan Sease; and Tracee Shevlin.

The Mayo Clinic
mayoclinic

A 50-year-old New York woman who was diagnosed with a progressive blinding disease at age 13 was implanted with an experimental electronic eye implant that has partially restored her vision. A team led by Dr. Lucian V. Del Priore at NewYork-Presbyterian Hospital/Columbia University Medical Center performed the June 26 surgery — the first case of its kind in New York.

The first treatment aimed at restoring limited sight in people blinded by retinal disease, it is currently available as part of a multicenter clinical trial.

The implant — a component of the Argus™ II Retinal Stimulation System by Second Sight® Medical Products Inc., of Sylmar, Calif. — is designed to stimulate retinal cells directly. In a healthy eye, photoreceptor cells of the retina receive light and translate it into signals that are sent to the brain via the optic nerve. But in patients with a genetic, blinding disease called retinitis pigmentosa (RP), these light-processing cells gradually degenerate, leading to severe vision loss or total blindness.

“With this system, people who are functionally blind might begin to distinguish light from dark, recognize visual patterns, make out figures, see food on a plate and navigate in unfamiliar surroundings,” says Dr. Del Priore, site principal investigator, professor in the Department of Ophthalmology at Columbia University College of Physicians and Surgeons, and an ophthalmologist at NewYork-Presbyterian Hospital/Columbia University Medical Center. “In its current form, the device won’t restore full visual function — but if it dramatically reduces a patient’s disability, that is a major advance.”

Retinitis pigmentosa only affects the outer layer of retinal cells, leaving the inner layers healthy and capable of conducting electricity, Dr. Del Priore explains. Therefore, people with glaucoma, diabetic retinopathy, optic nerve disease, or a history of retinal detachment have been excluded from the study, as their level of retinal impairment is likely to be more severe and more generalized. At this point, the device is being tested exclusively in people with RP as part of a clinical trial offered at six sites across the country.

From Video Images to Sight

Argus II and its predecessor, Argus I, have already been implanted to reduce some aspects of vision loss in about 20 patients with RP in the United States. Dr. Del Priore and his surgical team are optimistic about the newest patient’s prospects, based on positive results in others who have participated in studies of the system thus far. The device was developed by Second Sight under the lead of Dr. Mark Humayun, who is currently at the University of Southern California. NewYork-Presbyterian/Columbia’s study coordinator, Elona Gavazi, was instrumental in screening and recruiting patients for the current study.

Argus II comprises three components: the implanted part, which is placed inside the patient’s eye; a tiny camera and transmitter, mounted on a pair of sunglasses; and a wireless microprocessor and battery pack, to be worn on a belt. The implant itself contains 60 tiny electrodes that are attached to the retina via a micro-wire roughly the width of a human hair. These administer electrical impulses to retinal cells, allowing the brain to perceive light.

Learning to See Again

Argus II is an innovative technology, Dr. Del Priore continues, but it is the rehabilitation process that will ensure a patient’s ability to benefit from the procedure. In fact, without visual training, the patient may not learn to use or accept the images being received.

The intensive phase of rehab takes about six months, he says, but the process can continue for a year or more. Rehabilitation, device training, along with functional assessment of the patient’s vision, will take place at Lighthouse International, a leading international non-profit vision rehabilitation and research organization, which is a collaborating institution with NewYork-Presbyterian/Columbia in the clinical trial.

At the Arlene R. Gordon Research Institute of Lighthouse International, senior fellow in vision science Aries Arditi, Ph.D., principal investigator of the Lighthouse site, will conduct psychophysical testing of the patient with and without the device to assess her performance of specific visual tasks, such as pattern recognition, aiming the device’s camera with head movements, and using the system for orientation and navigation. Dr. Arditi will also help determine which training procedures will allow the patient to make the most of her newly restored, if limited, vision — insights that can be carried forward for the benefit of future device recipients.

“We are very pleased to be a part of this groundbreaking and exciting research and to be working with such outstanding partners. Our collective work could have a profound effect on the estimated 400,000 Americans with retinitis pigmentosa and other retinal diseases,” states Dr. Arditi.

Source:
Jennifer Homa

New York- Presbyterian Hospital/Columbia University Medical Center

The impact of the genericization of Pfizer’s Xalatan at the end of March 2011 is reflected in changes to both current and anticipated ophthalmologist prescribing behavior for primary open angle glaucoma (POAG) patients. Among pharmacologically-treated patients, two-thirds are currently prescribed prostaglandin analogs, specifically Allergan’s Lumigan, Alcon’s Travatan Z, and Pfizer’s Xalatan, with the remaining use being split between fixed combination products (Allergan’s Combigan), beta blockers (Alcon’s Betoptic S), alpha agonists (Allergan’s Alphagan P), and carbonic anhydrase inhibitors (Alcon’s Azopt). Surveyed ophthalmologists report recent increased prescribing of Lumigan and Travatan Z in response to diminished insurance coverage for Xalatan in anticipation of generic latanoprost. Interestingly, almost one-half of ophthalmologists report frequent patient requests for a generic product reflecting the strong influence of cost within this patient population. While respondents anticipate continued use of prostaglandin analogs for the majority of their patients with POAG, Lumigan 0.01% is anticipated to pull ahead of Lumigan 0.03% over the next six months due to higher satisfaction with the low concentration formulation’s efficacy and tolerability profile.

While surgery is typically seen as a third or later line option for the treatment of POAG, general ophthalmologists and glaucoma specialists differ significantly in terms of when to use surgery and what types of surgical options (e.g. laser trabeculoplasty, trabeculectomy, aqueous shunts, nonpenetrating surgery, etc) are appropriate. In fact, the appropriate use of surgery remains a predominant area of discussion within the market.

Ophthalmologists report a high unmet need for products with unique mechanisms of action [other than intraocular pressure (IOP) lowering], neuroprotective properties, and a lower cost to patients. While awareness of products in development for the treatment of POAG is low, especially among general ophthalmologists, interest was highest for QLT’s sustained release, punctual plug delivery system of latanoprost among the six therapies in development that were profiled in the research. Unaided and aided awareness of aqueous shunts in development was low although glaucoma specialists were significantly more aware of aided brands, including the iStent shunt and the Eyepass shunt, compared to general ophthalmologists.

TreatmentTrends®: Glaucoma is an annual syndicated report series that provides a comprehensive view of the current and expected future management of glaucoma, with a focus on POAG, based on primary research. The survey was fielded in mid-March 2011 with 102 U.S. ophthalmologists, 45% of whom classify themselves as glaucoma specialists. TreatmentTrends: Glaucoma covers the use of drug classes and agents for the treatment of glaucoma, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth, and expected future use. In addition, respondents were queried about their awareness of and interest in products in development for the treatment of POAG.

Source:

BioTrends Research Group, LLC

Decision Resources, Inc.

View drug information on Alphagan; Lumigan; Travatan.

A government report says that contact lens injury is the leading cause of over 70,000 emergency department (ED) visits
every year for medical device-associated injury among US children and that more public health initiatives are needed to prevent
such easily averted injuries in children, which are often due to wearing lenses for too long and not cleaning them
properly.

The report, by researchers from the US Food and Drug Administration (FDA), is the first ever comprehensive study of medical
device-associated injuries among US children and appears in the 26 July issue of the journal Pediatrics.

The authors write that injury is currently the primary cause of death for children in the US, being responsible for around 16,000
deaths every year, with more than two thirds of them attributable to unintentional injuries.

Their study estimated that nearly 145,000 medical device associated injuries among children aged 0 to 21 years were seen in
emergency departments throughout the US during 2003 and 2004, involving 13 medical specialties.

This figure represents less than 1 per cent of the 20 million or so visits to emergency departments (ED) due to unintentional injury
in this population over the same 24 month period.

The report highlights include:

The most prevalent types of medical device associated injuries seen in EDs in 2003 and 2004 included contusions or
abrasions, foreign-body intrusions, punctures, lacerations, and infections.
The most frequently affected parts of the body were the eyeball, pubic region, finger, face, and ear.
Most of the children treated were adolescents aged 16 to 21 years, accounting for nearly half of the national estimate,
followed by 11 to 15 year olds, accounting for 1 in 5 visits.
The risk of attending ED due to medical device associated injury among adolescents 16 to 21 years of age was twice the risk
among 11 to 15 year olds and three times the risk among 3 to 10 year olds.
This pattern reflects the overall pattern of unintentional injury among US children.
More girls than boys were affected in the adolescent age group (16 to 21 years) and more boys than girls in the 10 years and
under group.
Nearly a third of the total medical device associated injuries among children involved ophthalmic devices, and more than one
fifth (23 per cent) involved contact lenses, with children aged 11 years and over being the most affected group, in line with
prescription trends.
The most frequently reported injury related to contact lenses were: corneal contusions and abrasions, conjunctivitis, and
hemorrhage: they were mostly superficial and did not require hospitalization.
Common reasons given for contact lens injury related to not following given instructions for when and how long to wear
them, and not following recommendations for correct cleaning, wearing, and care.
After ophthalmic devices, hypodermic needles were the next most commonly cited device, accounting for 8 per cent of the
overall estimate for medical device associated injuries among children.
The injury pattern in each age group tends to reflect the main developmental changes and disease risks of that
group.
For example, contact lens injury accounted for over 40 per cent of medical deviced associated injury in adolescents aged 16
to 21, and 16 per cent of injuries in this age group involved obstetric/gynecologic devices.
In contrast, the largest proportion of medical device associated injuries due to cardiovascular
devices, was among children under 5, and the most common medical device associated injury among the under 5s was related to
tympanostomy tube (ear grommet).

The authors concluded that the study “highlights the need to develop interventions to prevent pediatric device-related
injuries”.

In relation to contact lens wear, they recommend that practitioners give full detailed instruction on the routines for cleaning,
wearing and caring for contact lenses and review this carefully at follow up evaluations.

They also recommend that parents be involved in the entire process of lens fitting, care and follow up monitoring.

The report found that the most serious problems were infections and overdoses related to implanted devices such as brain shunts
for children with hydrocephalus (water on the brain), insulin pumps for diabetics and chest catheters for children receiving
chemotherapy at home.

However, of those affected by these injuries, only 6 per cent overall had to stay in hospital.

Dr. Steven Krug, head of emergency medicine at Chicago’s Children’s Memorial Hospital, told the Associated Press that home
care be challenging for families. Children have come to his emergency department because their catheter was damaged or
became infected.

Krug, who was not involved in the study, said that health professionals need to be aware of children that have these devices and
how to recognize or diagnose the problems they can cause.

“Emergency Department Visits for Medical Device-Associated Adverse Events Among Children.”
Cunlin Wang, Brock Hefflin, Judith U. Cope, Thomas P. Gross, Mary Beth Ritchie, Youlin Qi, Jianxiong Chu.
Pediatrics, Published online 26 July 2010
DOI:10.1542/peds.2010-0528

Additional source: Associated Press.

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