“Despite new medical and surgical interventions, AMD remains an important cause of loss of vision in the United States,” the authors write as background information in the article. The last nationally representative estimates of prevalence of AMD were based on the 1988-1994 Third National Health and Nutrition Examination Survey (NHANES III).
To update these estimates, Ronald Klein, MD, MPH, of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues analyzed data from the 2005 to 2008 NHANES. A total of 7,081 individuals age 40 or older were selected to participate and had photographs taken of both eyes. Digital images of the eyes were assessed for signs of AMD, including drusen, pigment changes and atrophy in the retina and surrounding tissue.
The overall prevalence of AMD among adults age 40 and older was an estimated 6.5 percent, which represented a decrease from the 9.4 percent reported in the 1988 to 1994 survey. The estimated prevalence of late AMD was 0.8 percent. Non-Hispanic black individuals age 60 and older had a lower prevalence of any AMD than non-Hispanic white individuals of the same age.
| B+L Voluntarily Recalls Soothe XH Drops |
|
Bausch + Lomb has voluntary recalled its Soothe Xtra Hydration eye drops, only available within the United States. B + L chose to initiate this recall based on a small number of consumer reports citing the presence of possible foreign matter in the tip of the bottles. Initial testing on the opened, partially used product has identified the particles as mold, and the company is conducting an ongoing investigation into the reports of mold in the tip of the bottles. A determination of future product distribution will be made at the close of this investigation, which could last several months.
Soothe Xtra Hydration eye drops have been available since April 2010 in the United States only. Approximately 1.3 million bottles have been distributed here. The Soothe Xtra Hydration eye drops are the only eye drops affected in this recall; all other Soothe eye products remain on the market. B + L has directly contacted U.S. retailers who have been shipped this product to initiate the recall and inform them of the steps they should take to return the product to us. The company has also contacted eye-care professionals to alert them of the recall. |
Could Chinese Drug Prevent Cataract?
Scientists are reporting a scientific basis for the long-standing belief that a widely used non-prescription drug in China and certain other countries can prevent and treat cataracts. Their study appears in Inorganic Chemistry, a journal of the American Chemical Society.
The study authors note that eyedrops containing pirenoxine, or PRX, have been reputed as a cataract remedy for almost 60 years. Despite the wide use of pirenoxine, there have been few scientific studies on its actual effects, they note.
To fill that gap, the scientists tested pirenoxine on cloudy solutions that mimic the chemical composition of the eye lens of cataract patients. The solutions contained crystallin — a common lens protein — combined with either calcium or selenite, two minerals whose increased levels appear to play key roles in the development of cataracts. Presence of PRX reduced the cloudiness of the lens solution containing calcium by 38 percent and reduced the cloudiness of the selenite solution by 11 percent. “These results may provide a rationale for using PRX as an anti-cataract agent and warrant further biological studies,” the article notes.
FDA Seeks More Data on Iluvien Studies
Alimera Sciences announced that it received a Complete Response Letter (CRL) from the Food and Drug Ad-ministration regarding its New Drug Application for the investigational drug Iluvien. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.
The application seeks the approval to market Iluvien (fluocinolone acetonide intravitreal insert), Alimera’s investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema. Alimera submitted the Iluvien NDA to the FDA on June 29, 2010 with safety and efficacy data through month 24 of the FAME Study. The FDA granted the NDA Priority Review status on August 30, 2010.
No new clinical studies were requested in the CRL. However, the FDA asked for analyses of the safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted to the FDA, to further assess the relative benefits and risks of Iluvien. Alimera has completed month 36 of the study and is preparing the analyses the FDA requested. The FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of Iluvien, which Alimera is in the process of compiling.
The FDA also indicated that it had observed deficiencies in current good manufacturing practices during its facility inspections of two of Alimera’s third-party manufacturers, which were completed in August and September of 2010, and that all facilities and controls will need to comply with the manufacturing practices. Alimera’s third-party manufacturers are in the process of resolving these deficiencies.
“We appreciate the FDA’s efforts to complete a Priority Review of our New Drug Application and look forward to working closely with the FDA toward approval of Iluvien for the treatment of DME,” said Dan Myers, president and chief executive officer of Alimera. “To expedite the process, we have requested a meeting with the FDA to clarify the path to regulatory approval.”
Glaucoma and Parkinson’s Connection?
Researchers at Baltimore’s Kennedy Krieger Institute and collaborating institutions report that they have identified a new and unexpected biological pathway that appears to contribute to the development of glaucoma and its resulting vision loss. The work was reported in the January Proceedings of the National Academy of Sciences.
In the study, researchers report a series of findings that offer novel insights into cellular and molecular mechanisms operating at the optic nerve head in two mouse models of glaucoma. Most notably, they discovered that at a specific location within the optic nerve head, there is a unique class of cells called astrocytes that demonstrate properties that appear to make them a critical factor in the visual blinding that occurs in glaucoma.
Further, at this same site, the researchers found abnormal forms of a protein called gamma synuclein that is similar to abnormal forms of alpha synuclein, a related protein known for its key role in cell loss in Parkinson’s disease. The findings suggest that a biological process similar to Parkinson’s disease unfolds in glaucoma at the specific anatomical location pinpointed in this study for the first time.
Finally, the researchers discovered that at this anatomical location, there is a surprising process whereby astrocytes remove the debris of neurons, the cells that die in neurodegenerative disorders such as glaucoma. It is likely that this newly discovered process involving removal of the debris of one cell by a neighboring cell is important not only in glaucoma and Parkinson’s disease, but also for many neurodegenerative diseases.
Future studies will examine this novel pathway and molecular/cellular mechanism to understand precisely what steps go awry in glaucoma and what can be controlled pharmacologically to identify interventions that slow the disease progression.
New Take on CL Bacterial Infections
Researchers at National Jewish Health and the University of Texas South-western Medical Center have dis-covered a new method to fight bacterial infections associated with contact lenses. The method may also have applications for bacterial in-fections associated with severe burns and cystic fibrosis. The results were published online January 18 in the journal Investigative Ophthalmology and Visual Science.
“Infections by Pseudomonas aeruginosa can cause severe scarring and vision loss when they spread to the cornea,” said senior author Jerry Nick, MD, associate professor of medicine at National Jewish Health. “By breaking apart a molecular scaffolding that encases the organisms and makes them more difficult to eradicate, we were able to significantly reduce bacterial infection of the cornea.”
Blinking helps remove bacterial organisms from the surface of the eye. Contact lenses, however, inhibit the effectiveness of blinking eyelids. The formation of a biofilm, a matrix that harbors and encases communities of the organisms, on the lenses makes it difficult to eradicate bacteria. The researchers confirmed earlier findings that cellular debris from immune cells fighting the infection actually provide the raw materials for the biofilm—DNA, actin and histones. So, they used the enzyme DNAase together with negatively charged poly aspartic acid to break down the chemical bonds of these elements that support the biofilm.
This treatment reduced biofilms on the contact lenses by 79.2 percent. The same treatment reduced infection of the cornea in an animal model by 41 percent. There was no evidence of any harm caused by the treatments.
Study: Fundus Camera in ER Beneficial
In a hospital emergency department, limited training in ophthalmoscopy, increased demands on physicians’ time, and underappreciation of the prognostic value of ocular fundus examination can place patients at risk for poor outcomes, say physicians at Emory University, Atlanta. In the January 27 New England Journal of Medicine, the group reports results of their FOTO-ED (Fundus Photography vs. Ophthalmoscopy Trial Outcomes in the Emergency Department) study, which hypothesized that the use of nonmydriatic fundus photography in the ER would result in increased detection of abnormalities in the ocular fundus relevant to emergency-department care, a majority of which would be missed during routine clini-cal practice in the department.
They enrolled 350 adult patients whose chief symptom on presentation to the ER was headache (65 percent), acute focal neurologic deficit (29 percent), or acute visual change (26 percent) or whose diastolic blood pressure was 120 mmHg or higher (6 percent). Patients could meet more than one inclusion criterion. Trained nurse practitioners obtained ocular fundus photographs with a nonmydriatic fundus camera. Photographs were reviewed by a neuro-ophthalmologist within 24 hours for findings relevant to treatment in the emergency department. The performance of ER physicians and the findings on direct ophthalmoscopy were prospectively recorded, with the physicians unaware of the photography results.
During routine evaluation, ophthalmoscopy was performed by an ER physician for only 48 of the 350 patients (14 percent). In 44 enrolled patients, relevant ocular findings (13 percent) were identified with the use of nonmydriatic fundus photography: 13 cases of optic-nerve edema, 13 intraocular hemorrhages, 10 instances of hypertensive retinopathy (grade 3 or 4), four cases of arterial vascular occlusion, and four instances of optic-nerve pallor. Eleven of the findings were known before patients presented to the ER. Of the remaining 33 relevant findings, six were identified on ophthalmologic consultation to the ER and 27 solely by means of fundus photography (82 percent). (In only five of these 33 patients was ophthalmoscopy performed by an ER physician; results were recorded as normal for all five.) Photos were of diagnostic value for 97 percent of enrolled patients.
