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Congressional Justification for FY 2008

National Eye Institute

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Justification of Budget Request

National Eye Institute

Authorizing Legislation: Section 301 and Title IV of the Public Health Service Act, as amended.

Budget Authority:

FY2006 Actual FY2007 Continuing Resolution FY2008 Estimate Increase or Decrease
FTEs BA FTEs BA FTEs BA FTEs BA
207 $665,768,000 213 $666,315,000 215 $667,820,000 2 $1,505,000

This document provides justification for the Fiscal Year (FY) 2008 activities of the National Eye Institute including HIV/AIDS activities. Details of the FY 2008 HIV/AIDS activities are in the "Office of AIDS Research (OAR)" section of the Overview. Details on the Roadmap/Common Fund are located in the Overview, Volume One.

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Major Changes in the Fiscal Year 2008 Budget Request

Major changes by budget mechanism and/or budget activity detail are briefly described below. Note that there may be overlap between budget mechanism and activity detail and these highlights will not sum to the total change for the FY 2008 budget request for NEI which is $1.5 million more than the FY 2007 Estimate, for a total of $667.8 million.

Research Project Grants (-$0.1 million, total $396.7 million): NEI will support a total of 1,059 Research Project Grant (RPG) awards in FY 2008. Noncompeting RPGs will decrease by 67 awards and decrease by $15.4 million. Competing RPGs will increase by 31 awards and increase by $10.8 million.

Research Careers (+$1.4 million; total $17.1 million): NEI will support the Pathway to Independence program, by funding an additional 4 awards in FY 2008. Total support for the Pathway program in FY 2008 is 8 awards and $1.3 million.

NIH Roadmap for Biomedical Research (+$.8 million; total $8.785 million): NEI will continue its support of the NIH Roadmap, an incubator for new ideas and initiatives that will accelerate the pace of discovery, in FY 2008.

R&D Contracts (+$.5 million; total $36.1 million): Program Evaluation increases 3.5% in FY 2008.

History of Budget Authority and FTEs:

Funding Levels by Fiscal Year

FTEs by Fiscal Year

Distribution by Mechanism:

FY 2008 Budget Mechanism (Dollars in Thousands)

Change by Selected Mechanisms:

FY 2008 Estimate, Percent Change from FY 2007 Mechanism

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Director's Overview

The National Eye Institute's (NEI) mission is to conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of individuals who are visually impaired. Inherent in this mission is clinical research across the spectrum of diseases of the eye and disorders of vision, as well as the investigation of the normal tissue and normal visual processes that will help gain a more complete understanding of the abnormal processes that lead to these conditions. These investigations are conducted in hundreds of extramural laboratories and clinics throughout the U.S. and in NEI's own intramural research facilities in Bethesda, Maryland.

The NEI's research programs constantly evolve to meet new challenges. To make decisions to initiate new or expand existing research programs, NEI is guided by its strategic plan. This plan, developed through a process involving NEI program staff, outstanding vision researchers, and leading scientists from other disciplines, identified and prioritized scientific opportunities that NEI should consider for funding. Several new research projects and initiatives were undertaken in FY 2007 consistent with that plan, and some of these activities will be expanded in FY 2008.

NEI investigators have made significant discoveries to understand and treat common retinal disorders like age-related macular degeneration (AMD) and diabetic retinopathy. These findings have spurred NEI to further enhance the already productive efforts of the extramural and intramural investigators. In 2008, NEI will reinvigorate its intramural program to increase ophthalmic genetics research to further elucidate the genetics of retinal diseases. Several new principal investigators will be hired to advance the research. The enhancement of the intramural program allows the NEI to augment existing extramural resources to develop treatments for retinal diseases.

The Age-Related Eye Disease Study (AREDS), a multicenter study of cataract and AMD originally launched in 1992, will end in FY 2008. This study, which included a clinical trial, demonstrated that high-dose antioxidant supplements (beta-carotene, vitamins C and E, and zinc) can slow the progression of AMD. More than 20 manuscripts have been published based on the results of this study with more in preparation.

As AREDS winds down, NEI will significantly expand AREDS 2. This multi-center study (up to 100 clinical sites) is a randomized, controlled clinical trial of oral supplementation lutein/zeaxanthin and omega-3 long chain polyunsaturated fatty acids for the prevention of advanced AMD and cataract. This study has started recruitment and will follow patients for 5 years.

In FY 2007, the NEI extramural program created a new initiative to investigate the role of inflammation in degenerative eye diseases such as AMD, uveitis and other chronic disorders of the eye. This initiative will expand in FY 2008 to leverage the latest knowledge of the molecular and cellular aspects of inflammation and study the development and progression of degenerative eye diseases. A second emphasis is to expand our knowledge of how the inflammatory process is kept under tight control using the eye as a model system. This knowledge will be pivotal to the development of new diagnostic and intervention strategies to halt and reverse the progression of degenerative eye diseases.

Diabetic retinopathy, a complication of diabetes, is a leading cause of vision loss among Americans. Diabetic retinopathy is characterized by the growth of abnormal blood vessels that damage the retina. Recent progress has led to a number of promising investigational therapies that are poised to enter clinical trials in FY 2008. A large clinical trial network of experienced clinicians is essential to the conduct of these trials. Therefore, NEI has developed the Diabetic Retinopathy Clinical Research Network, a cooperative research group that includes clinicians from academic and private practice. The network will continue to expand its activities in FY 2008.

The NEI extramural program began funding a phase I clinical trial in FY 2007 to evaluate gene transfer therapy for a rare but severe retinal degenerative disease called Leber's congenital amaurosis (LCA). It will expand in FY 2008 and represents a classic example of translational research, the effort to "translate" laboratory findings into investigational therapies. NEI-supported researchers first cloned a gene for LCA in humans and dogs in 1997. In 2000, a group of NEI extramural investigators restored vision in dogs with LCA using a single injection of gene therapy. Since that time investigators have completed pre-clinical work and have received regulatory approval to evaluate this promising therapy in patients.

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Justification of the FY 2008 Budget by Activity Detail

Overall Budget Policy:

The first priority has been and continues to be funding the highest quality investigator-initiated research applications that help achieve the goals and objectives outlined in the strategic plan. To that end, the principle factor considered in determining which applications are funded continues to be the scientific and technical merit of the application, as evaluated through the peer review system, combined with the programmatic considerations of NEI, and recommendations of the National Advisory Eye Council.

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Retinal Diseases Research:

The retina is the light-sensitive neural tissue lining the back of the eye. The retina is susceptible to a variety of sight-threatening conditions including age-related macular degeneration, diabetic retinopathy, retinopathy of prematurity, retinitis pigmentosa, Usher's syndrome, ocular albinism, retinal detachment, uveitis (inflammation), and eye cancer. The overarching goals of the retinal disease research area are to understand the disease mechanisms that cause vision loss and to develop therapies that overcome the underlying pathology. To meet these goals, NEI supports research to isolate retinal disease genes, determine the function and structure of the resultant proteins in health and disease, and evaluate potential new therapies.

Budget Policy:

The FY 2008 budget estimate for Retinal Diseases Research activities is $263.3 million, a change of +$0.4 million or +0.2% from the FY 2007 estimate. The program plans for FY 2008 and accomplishments expected include an acceleration of research on the genetic and environmental basis for AMD, including the role of possible immunological factors. This will include an expansion of genome wide association studies and related efforts in bioinformatics. NEI will support projects that address the possible restoration of vision in retinal degenerative diseases by building on recent advances in cell transplantation and precursor cell biology, including the use of bone marrow stem cell transplantation, and on "re-engineering" the production of light-sensitive proteins in retinal neurons. Research will continue in efforts to control abnormal new blood vessel growth (angiogenesis) in a number of eye diseases, and will include the conduct of clinical trials in this area. These areas were among those designated as research priorities in NEI's latest strategic plan. The program plans for FY 2008 also include the conclusion of the remarkably productive Age-Related Eye Disease Study (AREDS), a multicenter study of cataract and AMD. AREDS demonstrated that high-dose antioxidant supplements (beta-carotene, vitamins C and E, and zinc) can slow the progression of AMD, and added to our understanding of the epidemiology of cataract and AMD, including the demonstration of new genetic associations. NEI will expand the activities of AREDS 2 to evaluate the use of additional oral supplements for the treatment of AMD and cataract. NEI also plans to continue collaborating with the National Heart Lung and Blood Institute on the follow-up ocular component of the Multi-Ethnic Study of Atherosclerosis (MESA) study. The study is attempting to identify factors that predict the development of symptoms and progression to overt cardiovascular disease in different ethnic groups in diverse geographical locations.

Portrait of a Program: Age-Related Eye Diseases Study 1 and 2

FY 2007 Level: $4.1 million
FY 2008 Level: $5.3 million
Change $1.2 million

Previous epidemiologic studies have suggested that antioxidant vitamins and minerals might prevent or delay the progression of AMD. Acting on those findings, NEI initiated a large study called the Age-Related Eye Disease Study (AREDS) in 1992. AREDS included a clinical trial that found antioxidant supplementation was beneficial in delaying the progression to the more severe stage of the disease. AREDS also added to our understanding of the epidemiology of AMD and cataract. DNA samples from AREDS participants were crucial in uncovering genetic associations for the disease. Data from AREDS and other studies suggested that lutein/zeaxanthin and omega-3 long chain polyunsaturated fatty acids might also have benefit in AMD and cataract. Leveraging these findings, NEI began AREDS 2, a multicenter study that will include up to 100 clinical sites. AREDS 2 will be greatly expanded in 2008 to evaluate these nutrients in the prevention of advanced AMD and cataract. Additional arms of the study will evaluate different formulations than the one used in the original AREDS. The AREDS 2 study will run through 2012.

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Corneal Diseases, Cataract, and Glaucoma Research:

Corneal diseases, cataract, and glaucoma are among the most prevalent disorders of the eye. The cornea is the transparent tissue at the front of the eye that directs incoming light onto the lens and retina. Corneal diseases and injuries can be extremely painful, requiring immediate medical attention. NEI corneal research is focused on understanding the biology of the cornea as part of a physiological system that includes tear film, eyelids, conjunctiva and other ocular tissues. NEI grantees are also exploring how the cornea promotes wound healing while still maintaining transparency and the molecular causes of corneal dystrophies. Cataract, an opacity of the lens of the eye, interferes with vision and is the leading cause of blindness in developing countries. In the U.S., cataract is also a major public health problem. An estimated 27 million Americans over age 40 have cataract or have had surgery to remove the lens opacification. By 2020 researchers estimate that about 40 million Americans will be affected by cataract 1. The enormous economic burden of cataract will only worsen as the American population ages. NEI cataract research area seeks to understand the physiological basis of lens transparency at the cellular and molecular levels and seeks strategies to prevent cataract formation and progression. Glaucoma is a group of eye disorders that share a distinct type of optic nerve damage, which can lead to blindness. Glaucoma is a major public health problem and the leading cause of blindness in African Americans. Approximately 2.2 million Americans have been diagnosed with glaucoma and the prevalence of the disease will rise to a projected 3 million by 20202. Glaucoma research aims to understand the complex genetic factors that lead to common forms of the disease and to develop treatments that protect ganglion cells from the damage that leads to vision loss.

Budget Policy:

The FY 2008 budget estimate for Corneal Diseases, Cataract, and Glaucoma Research activities is $164.4 million, a change of +$0.3 million or +0.2% from the FY 2007 estimate. The program plans for FY 2008 and accomplishments expected include following up on a recent finding that certain receptors that bind to vascular endothelial growth factor may play an important role in maintaining the normal transparency of the cornea by blocking the formation of new blood vessel growth. Research will continue to explore the role of precursor cells in accelerating corneal wound healing. The cornea is the most densely innervated tissue in the body and is extremely painful when subjected to trauma; however, relatively little is known of interventions, which could limit and/or reduce corneal pain. NEI expects to fund new projects to identify therapeutic approaches. A growing body of evidence suggests that movement of nutrients through small channels between cells in the lens, known as gap junctions, plays a significant role in maintaining the function of lens epithelial cells. Projects will be funded to examine the possible contribution of defects in the gap junctions in the development of cataracts. Genome wide association studies and related bioinformatics efforts will be launched to explore further the role of genetics and the environment on the development of glaucoma and to understand better the differential response of individuals to glaucoma medications. Research will also be conducted to follow up on the surprising finding in an animal model of glaucoma that death of retinal ganglion cells, a hallmark of the disease, may be initiated by the immunologic destruction of certain cells that normally surround and support the optic nerve. NEI will expand its collaborative participation in the Age Gene/Environment Susceptibility Study with the National Institute on Aging and several other participating institutes. NEI will fund the follow-up ocular component of this study, which is investigating the contribution of candidate genes and the environment in diseases that are common in old age.

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Sensorimotor Disorders and Rehabilitation Research:

Sensorimotor disorders such as strabismus (misalignment of the eyes) and amblyopia (commonly known as "lazy eye") occur during development and affect 2-4 percent of the U.S. population3,4. The correction of strabismus is one of the most frequently-performed ophthalmic surgical procedures. NEI's sensorimotor research goals center on gaining a better understanding of the development of the visual system in children at high risk for strabismus and amblyopia, and to understand the neural circuitry and muscular mechanisms that control gaze. Refractive errors, such as nearsightedness (myopia), farsightedness (hyperopia) and astigmatism are the most common, correctable visual disorders. A major goal of understanding how to prevent refractive error is to articulate the biochemical pathways that govern eye growth and to uncover the risk factors associated with refractive errors. Much of the cerebral cortex is devoted to processing the images that flood our eyes. The visual cortex also connects with many regions of the brain that govern memory, language, movement, and a myriad of other cognitive abilities. NEI's visual processing grant portfolio is prioritized to understand how the brain processes visual information, how neural activity is related to visual perception, and how the visual system interacts with other cognitive systems. Three million Americans now have low vision, a term used to describe chronic visual conditions that are not correctable by eye glasses or contact lenses5. The NEI supports rehabilitation research on improving the quality of life of persons with visual impairments by helping them maximize the use of remaining vision and by devising improved aids to assist those without useful vision.

Budget Policy:

The FY 2008 budget estimate for Sensorimotor Disorders and Rehabilitation Research activities is $142.1 million, a change of +$0.2 million or +0.2% from the FY 2007 estimate. The program plans for FY 2008 and accomplishments expected include pursuing the research finding of several genes involved in Leber's Hereditary Optic Neuropathy, a genetic disease that frequently results in a substantial loss of central vision. The development of animal models carrying these mutations could lead to successful gene-based therapy for this disease. Research will also pursue remarkable new findings about how the activity of certain brain cells allows us to perceive a stable view of our surroundings despite constant head and eye movements, as highlighted in NEI's strategic plan. This research will help us to understand better the neural control of eye movements and associated disorders, and may have applicability in other sensory systems.

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Intramural Research:

The NEI intramural research program conducts research on diseases of the eye and disorders of vision in its laboratories and clinic located on the NIH campus in Bethesda and in other facilities in Rockville, Maryland. Among the research activities supported within NEI intramural program are: planning, developing, and conducting human population studies concerned with the cause, prevention, and treatment of eye disease and vision disorders, with emphasis on the major causes of blindness; conducting basic research on cellular and molecular mechanisms of the eye development, including the expression and function of genes within the eye; conducting research in immunology and infectious diseases of the eye to better understand the normal physiologic state and the processes which perturb it, with special emphasis on inflammatory mechanisms in the eye as a model system; and, developing a better understanding of the fundamental brain mechanisms that allow one of the most critical of human abilities, i.e., the ability to guide our eye movements under neurosensory control.

Budget Policy:

The FY 2008 budget estimate for Intramural Research activities is $66.5 million, a change of -0.7% from the FY 2007 estimate. The program plans for FY 2008 and accomplishments expected include the closure of several research Sections and one Laboratory due to a shift in program emphasis. A recruitment effort is underway that will result in the launch or expansion of several new research activities of higher priority. These activities will include the development of a new program on retinal neurodegeneration research that will combine fundamental, pre-clinical, and translational research, designed to accelerate the introduction of therapeutic interventions in various eye diseases. These therapeutic approaches will include gene therapy, small molecules, neurotrophic factors, and cell based systems, in combination with a variety of treatment delivery technologies. NEI will also develop clinical neuroscience research capabilities within the Laboratory of Sensorimotor Research that will build on an already very strong fundamental research program focused on the experimental and theoretical analysis of normal and abnormal eye movements and visual perception.

Portrait of a Program: National Ophthalmic Disease Genotyping Network (eyeGENE)

FY 2007 Level: $2.2 million
FY 2008 Level: $2.8 million
Change $0.6 million

Centralized genetic repositories are crucial to the understanding and treatment of rare diseases. The availability of detailed genetic information from patients with eye disease allows investigators to isolate genes that cause disease and to better understand the relationship between a gene defect and the resultant pathology or phenotype. A genetic repository can also serve as a registry to identify suitable candidates for clinical studies. In FY 2007, the NEI began eyeGENE, a genotyping program to facilitate the study of eye diseases. This program will be enhanced in FY 2008. The eyeGENE includes a DNA repository, laboratories to sequence the genes in patient DNA, and a research database of genotype data for researchers to access.

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Research Management and Support:

Research management and support (RMS) funds are used to sustain, guide, and monitor the extramural and intramural research program activities of NEI. Included in these funds are the amounts necessary to provide personnel to carry out these management functions, as well as the funds to provide human resource support, training, travel, purchasing, facilities, budget, research planning, information technology, extramural grant award and program management. The Institute currently oversees more than 1,400 grants and contracts, including research project grants, centers, research career awards, cooperative clinical research awards, and research and development contracts.

Budget Policy:

The FY 2008 budget estimate for Research Management and Support activities is $22.7 million, a change of $.2 million or 1.0% from the FY 2007 estimate. The management plans for FY 2008 and accomplishments expected include the continued use of RMS funds both efficiently and effectively. For example, as part of its strategic planning process, NEI scientific programs undergo regular portfolio review at its National Advisory Eye Council meetings. NEI recently created the Management Policy and Analysis Branch (MPAB) in part to perform management reviews of Divisions and Branches, which focus on setting and measuring short term targets and long term goals. Additionally, NEI is participating in a variety of trans-NIH objectives such as using Knowledge Management to implement a transparent coding and disease reporting system and embracing the electronic submission of grant applications which will replace previous paper applications.

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  1. Prevalence of cataract and pseudophakia/aphakia among adults in the United States. Arch Ophthalmol 122: 487-494, 2004.
  2. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol 122: 532-538, 2004.
  3. The evolving concept of amblyopia: a challenge to epidemiologists. Am J Epidemiol 118(2): 192-205, 1983.
  4. Baltimore Vision Screening Project. Ophthalmology 103(1): 105-109, 1996.
  5. Blindness and Visual Impairment in an American Urban Population. Arch Ophthalmol 108: 286-290, 1990.


Department of Health and Human Services NIH, the National Institutes of Health USA.gov