Month: December 2013

Liquid tablet forms of washing detergent pose a new household risk to children, state the authors of a correspondence letter in this week’s issue of THE LANCET.

Noel Horgan (Children’s University Hospital, Dublin, Ireland) and colleagues treated six children, over a 6-month period, with alkali eye injury caused by a liquid detergent tablet.

The children, aged 18 months to 3 years, had squeezed a tablet causing it to burst and spray detergent over their eyes. The children presented with damage to the cells lining the cornea, and four had significant injury to the conjunctiva–the thin transparent tissue that covers the outer surface of the eye.

All patients were admitted to hospital and stayed for 2 to 5 days. The damaged eye cells eventually healed. The authors note that more serious damage may have resulted if the children had not had prompt irrigation of their eyes after the chemical splash.

Dr Horgan states: “Alkali eye injuries are potentially the most severe form of chemical eye injury�Although the detergent packaging displays a warning that the contents are irritant, and that the products should be kept out of reach of children, the real risk of injury posed may not be appreciated by consumers. We propose that the warning label should be more obvious, and that the packaging should be modified to make it child proof.”

Contact: Joe Santangelo
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Lancet
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In his article in the current issue of Deutsches Arzteblatt International (Dtsch Arztebl Int 2010; 107[28-29]: 495-9), Wolf A. Lagreze examines whether or not childhood screening for vision disorders in preschool children is worthwhile.

Eye disorders can occur even in very young children and may threaten their vision. Retinopathy of prematurity is currently the only eye disorder for which ophthalmological screening is provided in Germany. Childhood screening for other eye disorders would also be worthwhile if the disorder to be diagnosed were sufficiently common and successful treatment guaranteed.

Amblyopia is defined as a unilateral sight disorder that can weaken the affected eye or the visual apparatus as a whole. Strabismus, for example, hinders visual development and can be treated by temporarily covering the better eye.

The most significant study conducted to date tested 6081 seven-year-olds and found that those who had been screened and treated as preschoolers developed visual problems somewhat less frequently than those who had not. The frequency of visual disorders also seems to be correlated to membership of certain social strata.

German law establishes vision screening as part of routine childhood examination. However, as not all the doctors who carry out such examination currently receive sufficient training, and as their remuneration is often too low to cover their costs, the program is probably unable to provide what the law establishes.

Source:
Dr. Wolf Lagreze

Deutsches Aerzteblatt International

In children with vascular birthmarks around the eye, even partial blockage of vision can lead to visual loss due to amblyopia. Now a simple test can detect early evidence of amblyopia in infants too young for conventional vision testing, reports a study in the April issue of the American Journal of Ophthalmology published by Elsevier.

Led by Dr. William V. Good of Smith-Kettlewell Eye Research Institute, San Francisco, the researchers performed the early vision test in four infants with vascular birthmarks, or hemangiomas, on the upper or lower eyelids. These birthmarks generally resolve over time without treatment. However, if they are blocking part of the field of vision in the affected eye, they can lead to permanent reductions in vision, called amblyopia.

The test, called “sweep visual evoked potential vernier acuity,” works by monitoring brain responses to changes in the alignment of two lines. None of the four infants had had any clinical evidence of amblyopia.

However, the vernier acuity measurements identified early visual abnormalities in the eyes with birthmarks. Brainwave responses to the shifting lines were significantly reduced in the eyes affected by hemangiomas, compared to the fellow eyes.

Vascular birthmarks occurring in the area around the eye have the potential to cause significant vision loss before the abnormality resolves, or before the child is old enough for conventional vision testing. Dr. Good commented, “Many congenital ocular or eyelid abnormalities present physicians with a management conundrum: Is treatment for potential amblyopia necessary?”

The new results show that vernier visual acuity measurements are a promising tool for early detection of “amblyopia-like effects” in children with eyelid hemangiomas, who can then be targeted for treatment. “This study has implications for the management of children with intermittent occlusion, who may develop amblyopia even when the clinical assessment is negative,” added Dr. Good. “It is likely that these findings extend to other eyelid problems, including congenital ptosis [drooping eyelid], where amblyopia may be present even in the absence of clinical features for amblyopia.”

Elsevier
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Treating trachoma, an eye infection that can lead to blindness, with a single mass antibiotic distribution in Ethiopian communities with high prevalence of infection is not effective in eliminating the disease, according to a study in the March 8 issue of JAMA.

At present, trachoma remains the most important infectious cause of blindness in the world, according to background information in the article. To reduce this infection (due to Chlamydia trachomatis), the World Health Organization (WHO) has recommended communitywide antibiotic distributions as part of its strategy to eliminate this infection as a public health concern by the year 2020. Current WHO guidelines recommend 3 annual mass distributions. It has been suggested that infection might not return after a single mass treatment with high coverage.

Jaya D. Chidambaram, M.B.B.S., of the University of California, San Francisco, and colleagues investigated whether ocular chlamydial infection returns to the community in the long term after a single mass antibiotic treatment in a high-prevalence setting. Eight villages in Ethiopia were followed up for 24 months from March 2003 to March 2005 after receipt of a single mass treatment of single dose oral azithromycin was offered to all residents who were aged 1 year or older. Fifteen untreated villages were randomly chosen and enrolled 12 months into the program. Children aged 1 to 5 years were monitored because this age group is known to have the highest prevalence of ocular chlamydial infection in the community and may form a core group for transmission.

Five hundred fifteen children were examined for ocular chlamydial infection at baseline. For the follow-up examinations, the average participation rate was 83 percent. Prior to treatment, the average prevalence of infection in children aged 1 to 5 years by village was 43.5 percent. By 2 months after treatment, the average prevalence of infection had decreased to 5.1 percent, which was significantly lower than baseline. By 24 months after treatment, the average prevalence of infection had risen to 11.3 percent.

The prevalence of infection varied considerably by village; 7 of the 8 villages had more infection in children at 24 months than at 2 months. In the remaining village, infection in children was reduced from 36 percent at baseline to 0 at all 5 subsequent visits. Villages enrolled at 12 months had significantly fewer infections than those enrolled 12 months earlier.

“Our results suggest that if infection is not eliminated by a single mass antibiotic treatment, then it predictably returns into the community, at least in this hyperendemic [area of high prevalence] area in 1- to 5-year-old children. However, infection comes back slowly and does not approach baseline prevalence even by 2 years,” the authors write. “� repeated treatments or other measures will be necessary for elimination of infection, as recommended by WHO. A single treatment will not suffice.”
(JAMA. 2006;295:1142-1146.)

For funding/support information, please see the JAMA article.

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Sirion Therapeutics, Inc., a
privately held ophthalmic-focused biopharmaceutical company, announced preliminary results from a pivotal anterior uveitis trial that
compared Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% dosed four
times daily (QID) to Pred Forte(R) (prednisolone acetate ophthalmic
suspension) 1%, dosed eight times daily. Durezol is a topical ophthalmic
corticosteroid indicated for the treatment of inflammation and pain
associated with ocular surgery; it was approved by the US Food and Drug
Administration in June 2008. Pred Forte(R) is the registered trademark of
Allergan, Inc.

Ninety patients with endogenous anterior uveitis were studied in a
multicenter, randomized, double-masked trial that compared the efficacy and
safety of Durezol QID with Pred Forte eight times a day. Treatment for both
study groups was administered for 14 days, with 2 weeks of tapering at half
the dose and 2 weeks of follow-up (for a total 42 days) after initiation of
therapy.

The primary endpoint was the difference from baseline in anterior
chamber (AC) cell grades between the Durezol and Pred Forte groups. At Day
14, the Durezol group achieved a mean cell grade reduction of 2.1, compared
to 1.9 in the Pred Forte group, confirming the noninferiority of Durezol
dosed QID to Pred Forte dosed eight times a day.

“This study shows that Durezol is a potent steroid that can be used
effectively four times a day to reduce inflammation in patients with
moderate to severe uveitis,” explained C. Stephen Foster, MD, an
investigator in the trial and the founder and president of the
Massachusetts Eye Research and Surgery Institution. “This is especially
important since the US standard of care currently necessitates dosing
steroids every hour — and as frequently as every 15-30 minutes in more
severe cases. In addition, Durezol does not contain benzalkonium chloride
(BAK), a common ocular preservative known to cause corneal toxicity with
long-term use. This is especially important for patients with uveitis,
which is a chronic disease. A strong steroid like Durezol will be a very
valuable tool for ophthalmologists everywhere, allow patients to have an
easier dosing regimen, and will most likely become the new standard of care
for treating uveitis.”

In addition to reducing mean cell grade, a greater percentage of
patients receiving Durezol had an AC cell grade of 0 (less than or equal to
1 cell) than did the Pred Forte group at Day 14 (69% vs 62%, respectively).
This trend continued through Day 42.

Ocular discomfort and pain is a debilitating symptom of uveitis. In
this study, pain was assessed using a Visual Analog Scale. Durezol
demonstrated a numerical advantage in pain reduction from baseline over
Pred Forte at every time point in the study. As early as Day 3, the Durezol
group had a reduction in mean pain score of 58% vs 51% in the Pred Forte
group. At Day 7, these were 71% and 64%, respectively.

Durezol was also very effective in reducing the symptoms of anterior
ocular inflammation (pain/ocular discomfort, photophobia, blurred vision,
and lacrimation). The Durezol group achieved a mean reduction in total
symptom score of 76% vs 71% for Pred Forte at Day 14. This numerical
difference was maintained through Day 42 with the Durezol group reducing
the total symptom score by 86% vs 76% for the Pred Forte group.

The total sign score was also reduced to a greater degree in the
Durezol group when compared to the Pred Forte group: 6.5 vs 6.1 at Day 14,
respectively. Total sign score included the sums of posterior synechiae,
hypopyon, limbal injection, peripheral anterior synechiae, AC flare, AC
cell and keratic precipitate grades. The numerical advantage of Durezol
over Pred Forte in total sign score continued throughout the study period.

Two patients in each treatment arm experienced criterion increases in
intraocular pressure (defined as a pressure of greater than or equal to 21
mmHg and a change from baseline greater than or equal to 10mmHg at the same
visit). Another important safety finding was the number of patients
withdrawn from the study due to lack of efficacy. In the Pred Forte group,
12.5% of patients were withdrawn from the study, while no Durezol patients
were withdrawn from the study for these reasons. This difference was
significant, P=0.01.

The results from this study will be combined with data from previous
trials conducted in Japan to support a supplemental New Drug Application
for anterior uveitis. “The results of these trials are truly exciting,”
noted Barry Butler, CEO and President of Sirion Therapeutics. “Although
this study was not designed to detect the statistical superiority of one
drug over the other, the consistent numerical advantage of Durezol across
all endpoints is impressive. This is especially so, when you consider that
Pred Forte has 20 times the concentration of Durezol and was dosed twice as
often. This clearly demonstrates the potency of Durezol.”

About Uveitis

Uveitis is inflammation of the middle three layers of the eye: iris,
choroid, and ciliary body. In the US it is responsible for an estimated
30,000 new cases of legal blindness each year and up to 15% of all cases of
blindness. It affects 0.2% of the population in industrial nations, with as
much as 10 times that prevalence in the undeveloped world. The most common
form of the condition is anterior uveitis, associated primarily with
inflammation of the iris. If left untreated, uveitis can cause permanent
damage and vision loss due to the development of glaucoma, cataract, or
retinal edema. In addition to causing blindness, the severe pain and
photophobia that accompany anterior uveitis can be debilitating.

About Durezol

Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical
ophthalmic corticosteroid approved for the treatment of inflammation and
pain associated with ocular surgery. Difluprednate, the active ingredient
in Durezol, is a difluorinated prednisolone derivative that has potent
anti-inflammatory activity. Prior to US approval, the efficacy and safety
of difluprednate dosed four times a day in ocular inflammatory diseases had
been demonstrated in an extensive preclinical and clinical program in
Japan, including two studies in anterior uveitis and one in refractory
uveitis. In two US Phase 3 trials evaluating Durezol in patients diagnosed
with significant postoperative inflammation (more than 10 anterior chamber
cells), Durezol effectively reduced inflammation and pain.

Dosage and Administration

The recommended dosage and administration of Durezol in the treatment
of postoperative inflammation and pain is to instill one drop into the
conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours
after surgery and continuing throughout the first 2 weeks of the
postoperative period, followed by 2 times daily for a week with tapering
based on the response.

Important Safety Information

Like other corticosteroids, Durezol is contraindicated in patients with
viral diseases of the cornea and conjunctiva, and those with fungal or
mycobacterial infections of the eye or ocular structures. Prolonged use of
corticosteroids may increase the hazard of secondary ocular bacterial
infections, exacerbate the severity of ocular viral infections, and
increase the development of fungal infections of the cornea. It is
important to monitor intraocular pressure when using ophthalmic steroids.
The use of steroids after cataract surgery may delay healing and increase
the incidence of bleb formation.

Adverse reactions associated with ophthalmic steroids include elevated
intraocular pressure, which may be associated with optic nerve damage,
visual acuity and field defects, posterior subcapsular cataract formation,
secondary ocular infection from pathogens including herpes simplex, and
perforation of the globe where there is thinning of the cornea or sclera.

Ocular adverse reactions occurring in 5-15% of subjects in clinical
studies with Durezol included corneal edema, ciliary and conjunctival
hyperemia, eye pain, photophobia, posterior capsule opacification, anterior
chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in 1-5% of patients included
reduced visual acuity, punctate keratitis, eye inflammation, and iritis.
Ocular adverse events occurring in < 1% of patients included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, scleral hyperemia, and uveitis. Most of these events may have been the consequence of the surgical procedure. About Sirion Therapeutics, Inc. Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion’s diverse product portfolio includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, and geographic atrophy associated with dry AMD. For more information, please visit siriontherapeutics. Sirion Therapeutics, Inc.
siriontherapeutics

View drug information on Durezol.

This study examined whether iris recognition systems would fail if people were to develop sudden eye disease.

Our results showed that iris recognition was actually very reliable with most eye disease. However, there were problems in some patients with acute inflammation of the iris (iritis).

This disease could happen to people suddenly and without notice and may cause current iris recognition systems to fail. Thus, although the systems used generally performed well, there were still potential problems that demand more research before more widespread implementation of this technology in worldwide security applications.

Journal of the Royal Society Interface

Journal of the Royal Society Interface is the Society’s cross-disciplinary publication promoting research at the interface between the physical and life sciences. It offers rapidity, visibility and high-quality peer review and is ranked fifth in JCR’s multidisciplinary category. The journal also incorporates Interface Focus , a peer-reviewed, themed supplement, each issue of which concentrates on a specific cross-disciplinary subject.

Journal of the Royal Society Interface

In a step toward using human saliva to tell whether those stiff joints, memory lapses, and other telltale signs of aging are normal or red flags for disease, scientists are describing how the protein content of women’s saliva change with advancing age. The discovery could lead to a simple, noninvasive test for better diagnosing and treating certain age-related diseases in women, they suggest in a report in ACS’ Journal of Proteome Research, a monthly publication. These diseases include lupus, Sj?�grens syndrome (associated with dry mouth and dry eye), and other immune-related disorders that affect millions of women worldwide, often at higher rates than in men.

John Yates and colleagues note that human saliva contains many different proteins involved in digestion, disease fighting, and other functions. Scientists are seeking ways to use the proteins as molecular “fingerprints” to develop quick diagnostic tests that provide an alternative to the needle sticks currently needed for blood tests. To do that, they need detailed information on how normal aging affects these proteins.

The scientists analyzed saliva proteins in healthy women aged 20-30 and 55-65. They identified 293 proteins differed between the two age groups. Most were involved in the immune system’s defenses against infection. Older women had almost twice as many immune-related proteins than younger women. The results suggest that “it is critical to take into consideration these normal differences in protein expression when searching for clinically relevant, disease specific biomarkers,” the article notes.

Article: “Quantitative Analysis of Age Specific Variation in the Abundance of Human Female Parotid Salivary Proteins” pubs.acs/stoken/presspac/presspac/full/10.1021/pr900478h

Source: Michael Bernstein

American Chemical Society

We are pleased to announce that subject enrollment for the phase 2 clinical study of 0.15% UF-021 (generic name; isopropyl unoprostone; active ingredient of Rescula(R) eye-drops) in patients with retinitis pigmentosa has been completed.

We submitted the notification of the clinical trial in August 2008. Enrollment in the phase 2 study began at six clinical sites in late December 2008 and was completed on August 3, 2009.

The clinical study has progressed with no delay, no serious adverse effects, and only a few cases of discontinuation so far. Hereafter, we expect to complete the study by next spring, including data collection and analysis.

Retinitis pigmentosa is a progressive hereditary disease affecting nearly 50,000 people in Japan, which is characterized by night blindness. Patients generally suffer from peripheral visual field loss and low vision in the late stage of the disease. At present, there is no effective treatment for this disease.

We developed and launched isopropyl unoprostone eye-drops on the market as a drug for glaucoma and ocular hypertension in 1994. In recent studies on isopropyl unoprostone, the drug has been reported to present neuroprotective effects and a function to improve ocular circulation. Studies at some university hospitals have also suggested that isopropyl unoprostone eye-drops improve symptoms of retinitis pigmentosa or stop the progression of the disease.

We expect isopropyl unoprostone to become a unique drug for improvement of the quality of vision in patients with retinitis pigmentosa.

About R-Tech Ueno, Ltd.

R-Tech Ueno was established in September 1989 for the purpose of marketing and R&D of drugs. Under the leadership of the president, also a medical doctor, the company is developing new drugs on the theme “Physician-Oriented New Drug Innovation,” targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent.

The company’s main product Rescula(R) eye-drops 0.12% is a therapeutic drug for glaucoma and ocular hypertension and has been marketed in Japan since 1994. R-Tech Ueno was the first in the world to take advantage of the substance “prostone” in the development of Rescula(R). Prostone was discovered in 1980 by Dr. Ryuji Ueno, the founder of the company.

Rescula(R) eye-drops 0.12% that causes less topical and systemic adverse reactions, demonstrates steady ocular pressure decreasing action by twice-a-day instillation. Such excellent therapeutic effects are realized through its optic nerve protection and ocular blood flow-increasing mechanism.

Concerning Rescula(R) (isopropyl unoprostone) for the treatment of glaucoma and ocular hypertension, R-Tech Ueno concluded a contract with Sucampo Pharma Americas, Inc. in April 2009 for the approval and assignment of distributorship, as well as for licensing the relevant patents and granting exclusive right to manufacture and supply in the USA and Canada.

Source: R-Tech Ueno, Ltd

It was recently reported in the North Shore Women’s Journal that “dry eye affects approximately 12% of the US population. That’s over 30 million Americans!”

North Shore Women’s Journal

Only one prescription medication is available to treat the ocular inflammation that might occur because of a patient’s dry eye. However, there are a few means by which the symptoms of dry eye can be alleviated.

If you experience the feelings of dryness, burning, grittiness, or sensation of a foreign body in your eye, these feelings could be indicative of Dry Eye. In addition to noticing the symptoms of Dry Eye, it is important to note when they occur. If your symptoms worsen in winter when the air is dryer, or in air conditioned rooms where air is constantly blowing, or while at work where you’re looking at a computer screen all day, these are situations in which Dry Eye symptoms are often exacerbated, and you may notice them the most.

If you are one of the millions of people who suffer from dry eye, there are many ways to help treat your symptoms. In the future, we can look forward to the eventual development of new medications for dry eye sufferers that aim to treat the underlying condition as well as alleviating the discomfort of burning, dry, irritated eyes. The variety of treatments and possibilities for the future make the study of dry eye medications an interesting as well as rewarding field for both patients and doctors.

To read more about What Dry Eye is, How Dry Happens, Dry Eye and You and How to treat Dry Eye read the article in full at nswj. Just click on the EYE.

For more information about clinical research, call the dry eye clinical study unit at: Ophthalmic Research Associates: 1-866-EYE-DROP

Diane Marsh
THE FAT LOSS PATCH
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508-265-0403
nswj

Dr. Olivier Collignon of the University of Montreal’s Saint-Justine Hospital Research Centre compared the brain activity of people who can see and people who were born blind, and discovered that the part of the brain that normally works with our eyes to process vision and space perception can actually rewire itself to process sound information instead. The research was undertaken in collaboration with Dr Franco Lepore of the Centre for Research in Neuropsychology and Cognition and was published late yesterday in the Proceedings of the National Academy of Sciences.

The research builds on other studies which show that the blind have a heightened ability to process sounds as part of their space perception. “Although several studies have shown occipital regions of people who were born blind to be involved in nonvisual processing, whether the functional organization of the visual cortex observed in sighted individuals is maintained in the rewired occipital regions of the blind has only been recently investigated,” Collignon said. The visual cortex, as its name would suggest, is responsible for processing sight. The right and left hemisphere of the brain have one each. They are located at the back of the brain, which is called the occipital lobe. “Our study reveals that some regions of the right dorsal occipital stream do not require visual experience to develop a specialization for the processing of spatial information and are functionally integrated in the preexisting brain network dedicated to this ability.”

The researchers worked with 11 individuals who were born blind and 11 who were not. Their brain activity was analyzed via MRI scanning while they were subjected to a series of tones. “The results demonstrate the brain’s amazing plasticity,” Collignon said. Plasticity is a scientific term that refers to the brain’s ability to change as a result of an experience. “The brain designates a specific set of areas for spatial processing, even if it is deprived of its natural inputs since birth. The visually deprived brain is sufficiently flexible that it uses “neuronal niche” to develop and perform functions that are sufficiently close to the ones required by the remaining senses. Such a research demonstrates that the brain should be more considered as a function-oriented machine rather than a pure sensory machine”.

The findings raise questions regarding how this rewiring occurs during the development of blind new born babies. “In early life, the brain is sculpting itself on the basis of experience, with some synaptic connections eliminated and others strengthened,” Collignon noted. Synaptic connections enable our neurons, or brain cells, to communicate. “After a peak of development ending approximately at the age of 8 months, approximately 40% of the synapses of the visual cortex are gradually removed to reach a stable synaptic density at approximately the age of 11 years. It is possible that that the rewiring occurs as part of the maintenance of our ever changing neural connections, but this theory will require further research,” Collignon said.

Collignon’s study received funding from the Fondation de l’H??pital Sainte-Justine, the Fonds de la recherche en sant?� du Qu?�bec, the Canadian Institutes for Health Research, the Natural Sciences and Engineering Council of Canada, and the Fonds de la Recherche Scientifique of Belgium.

Sources: Universit?� de Montr?�al, AlphaGalileo Foundation.