As Infections Drop Worldwide, Chronic Illness Increases
According to the World Bank and the Institute for Health Metrics and Evaluation (IMHE), infectious disease is declining globally, but chronic illness is on the rise. The organizations released reports on September 4, 2013, that present data on six regions of the globe.1 In August, the IMHE reported that “the burden of noncommunicable diseases has been increasing, with the largest increases associated with diabetes. The leading risk factors for disease burden changed substantially between 1990 and 2010.” As people live longer, a greater proportion of the burden of disease is due to disability.2
Along those lines, in 2012, the Tema Eye Survey Study Group reported that “chronic eye disease such as cataract and glaucoma may represent a greater percentage of disease burden today because of the reduced prevalence of infectious causes of blindness, such as trachoma and onchocerciasis, from improvements in their prevention and treatment, as well as population shifts away from endemic regions and increased life expectancy in developing West African countries such as Ghana. In addition, improvements in economic status and urbanization have led to increased obesity and diabetes mellitus prevalence in Ghana and other developing African countries.”3
Alan L. Robin, MD, told Glaucoma Today that “preventable causes of [visual] impairment are approximated at 80% of all cases.4 As the population ages and general health improves in nations such as India and China (accounting for almost one-half of the world’s population), the number of older individuals susceptible to chronic diseases will increase. Glaucoma and diabetic retinopathy are already major issues in India.4-7 Better screening paradigms are needed to find susceptible individuals that will go blind within their lifetime. Better cost-effective treatments will also be necessary to eradicate needless blindness.” Dr. Robin is an associate professor of ophthalmology at the Wilmer Eye Institute and an associate professor of international health at the Bloomberg School of Public Health, both at Johns Hopkins University in Baltimore.
A higher level of chronic illness will change the demands on health care systems and providers worldwide. It could also have ramifications for people’s financial security and increase disparities in their access to health care.8 Moreover, an increase in chronic illness has significant implications for quality of life, and longer
lifespans mean greater concern about overpopulation.
1. Policy reports. Institute for Health Metrics and Evaluation website. http://www.healthmetricsandevaluation.org/publications/policy-reports. Accessed September 5, 2013.
2. Measuring the global burden of disease. Institute for Health Metrics and Evaluation website.
http://www.healthmetricsandevaluation.org/gbd/publications/summaries/measuring-global-burden-disease. Published August 2013. Accessed September 5, 2013.
3. Budenz DL, Bandi JR, Barton K, et al, for the Tema Eye Survey Study Group. Blindness and visual impairment in an urban West African population: the Tema Eye Survey. Ophthalmology. 2012;119:1744-1753.
4. Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012;96(5):614-618.
5. Ramakrishnan R, Nirmalan PK, Krishnadas R, et al. Glaucoma in a rural population of Southern India. The Aravind Comprehensive Eye Survey. Ophthalmology. 2003;110:1484-1490.
6. Thulasiraj RD, Nirmalan PK, Ramakrishnan R, et al. Blindness and vision impairment in a rural South Indian population: The Aravind Comprehensive Eye Survey. Ophthalmology. 2003;110:1491-1498.
7. Nirmalan PK, Katz J, Robin AL, et al. Prevalence of vitreoretinal disorders in a rural population of Southern India. Arch Ophthalmol. 2004;122:581-586.
8. Beaubien J. Chronic illnesses outpace infections as big killers worldwide. NPR website. http://www.npr.org/blogs/health/2013/09/04/218873813/chronic-illnesses-outpace-infections-as-big-killers-worldwide. Published September 4, 2013. Accessed September 4, 2013.
Allergan Asks FDA to Revise Guidance Concerning Restasis Generics
Allergan, Inc., has asked the FDA to revise its draft guidelines that state that a human clinical trial would not be necessary for a generic drugmaker to establish bioequivalence for Allergan’s dry eye disease drug Restasis (cyclosporine ophthalmic emulsion 0.05%), assuming the active ingredient is the same. The FDA opened the door to early generic competition for Restasis when it released this guidance in June. In it, the agency stated, “It does not appear that conducting a bioequivalence study with clinical endpoint for this drug product would be feasible or reliable due to the modest efficacy demonstrated by the Reference Listed Drug.”
In response, Allergan posted a 43-page letter on its website stating, “The Draft Guidance recommends that in vitro analyses alone be submitted to establish that a proposed generic drug product is bioequivalent to Allergan’s Restasis (cyclosporine) ophthalmic emulsion, 0.05% w/v (“Restasis”). For reasons explained below, that proposal is unsound both scientifically and legally. Allergan therefore requests that FDA replace the Draft Guidance with a revised guidance document that explains in vivo comparative clinical studies are required to demonstrate that a proposed generic product is bioequivalent to Restasis.”
Restasis, which was approved in the United States in 2002, is Allergan’s second-best-selling drug, behind Botox. The former is expected to generate sales of $850 to $890 million in 2013.
Quantel Medical Receives FDA Clearance of Solutis SLT Laser
The FDA cleared Quantel Medical’s Solutis selective laser trabeculoplasty (SLT) glaucoma laser for clinical use. The clearance follows the expiration of a patent issued to Massachusetts General Hospital that restricted Quantel Medical and several other laser manufacturers from marketing SLT in the United States, according to a news release.
Genetic Marker Identified for Elevated IOP
A genome-wide association study of 2,175 individuals from Sydney, Australia, revealed an association between IOP and a common variant at chromosome 7p21, a region between the genes GLCCl1 and ICA1. The researchers confirmed the findings in two replication cohorts in the United Kingdom involving 4,866 total individuals. According to the investigators, research has shown the former gene to have a role in various tissues’ sensitivity to glucocorticoids, whereas the latter “encodes a protein involved in the regulation of secretory vesicle trafficking. …Vesicular metabolism pathways have previously been ascribed a role in the pathobiology of [primary open-angle glaucoma].”1
Lead investigator Ananth Viswanathan, MD, PhD, stated that he and his colleagues “estimated that each copy of the variant increases the risk of developing glaucoma by 8%, and in established glaucoma, each copy gives an extra 6% likelihood of significant visual loss.” He noted that the study’s finding helps to elucidate the biological processes involved in glaucoma and could assist in identifying new targets for drug therapy.2
“The recent report by The Blue Mountains Eye Study and the Wellcome Trust Case Control Consortium 2 is truly exciting,” John Fingert, MD, PhD, told Glaucoma Today. “Their discovery of risk factors may lead glaucoma research in new directions to better understand the causes of ocular hypertension and glaucoma and ultimately to develop new sight-saving therapies.” Dr. Fingert is an associate professor in the Department of Ophthalmology and Visual Sciences, the Interdisciplinary Program in Genetics, and the Department of Anatomy and Cell Biology, all at the University of Iowa in Iowa City.
“This is an intriguing result given the relationship between corticosteroids and elevation of IOP,” Janey Wiggs, MD, PhD, told GT. “Future research studies to investigate the association between this genomic region and steroid responsiveness in glaucoma would be of interest.” Dr. Wiggs is the associate chief of ophthalmology clinical research and the associate director of the Ocular Genomics Institute at the Massachusetts Eye and Ear Infirmary in Boston.
1. The Blue Mountains Eye Study (BMES) and The Wellcome Trust Case Control Consortium 2 (WTCCC2). Genome-wide association study of intraocular pressure identifies the GLCCI1/ICA1 region as a glaucoma susceptibility locus [published online ahead of print July 7, 2013]. Hum Mol Genet. doi:10.1093/hmg/ddt29.
2. Genetic marker discovered for IOP. Optometry Today. http://www.optometry.co.uk/news-and-features/news/?article=4927. Published July 29, 2013. Accessed August 6, 2013.
Ocular Therapeutix Announces FDA Panel Meeting for the ReSure Sealant
The FDA has scheduled an Ophthalmic Devices Panel meeting on September 19, 2013, to discuss, make recommendations on, and vote on the Premarket Approval (PMA) application for ReSure Sealant (Ocular Therapeutix Inc.).
The proposed indications for use under review are the intraoperative management of clear corneal incisions with a wound leak, as demonstrated by a Seidel test, and the prevention of postoperative fluid egress after cataract or IOL surgery. If approved, the medical device would be the first and only FDA-approved sealant for ophthalmic use.
The randomized, parallel-armed clinical trial enrolled
488 patients at 24 investigative sites throughout the United States. The study tested the safety and efficacy of the device, relative to sutured closure, for the prevention of fluid egress within the first 7 days after surgery. Clear corneal cataract wound leaks are widely thought to be a contributing factor to some postsurgical complications. Presently, ophthalmologists use stromal hydration to close these incisions, but recent reports suggest that this method of wound closure may not be adequate to provide a watertight seal.1 FDA approval of an ophthalmic sealant would provide surgeons with a novel means of closing vulnerable incisions.
1. Masket S, Hovanesian JA, Raizman M, et al. Use of a calibrated force gauge in clear corneal cataract surgery to quantify point-pressure manipulation. J Cataract Refract Surg. 2013;39(4):511-518.
