AEVR Holds First-Ever Congressional Briefing on Uveitis

Featured speaker Gary N. Holland, M.D. (Jules Stein Eye Institute, David Geffen School of Medicine at UCLA) and Janine Austin Clayton, M.D. (National Institutes of Health Associate Director for Research on Women’s Health)

On June 3, AEVR’s Decade of Vision 2010-2020 Initiative joined with professional societies and patient groups (see box below) in hosting a first-ever Congressional Briefing entitled Inflammatory Eye Disease: Focus on Uveitis. Uveitis is a collection of complex inflammatory eye diseases with a large cost and quality of life burden that varies with sex, age, and race/ethnicity and remains poorly understood with incompletely effective treatments. The Briefing featured Gary N. Holland, M.D. , who serves as a Professor of Ophthalmology at the David Geffen School of Medicine at UCLA—where he holds the Jack H. Skirball Chair in Ocular Inflammatory Diseases—and as Director of the Ocular Inflammatory Disease Center at the Jules Stein Eye Institute.

Congressional Vision Caucus Co-Chair Cong. Gene Green (D-TX), right, receiving from Executive Director James Jorkasky (left) AEVR-affiliate NAEVR’s letter of appreciation for his leadership as Ranking Member of the Health Subcommittee of the House Energy and Commerce Committee in championing the 21st Century Cures Act legislation

The Briefing began with a welcome and thanks. After Congressional Vision Caucus Co-Chair Cong. Gene Green (D-TX) welcomed the packed room, AEVR Executive Director James Jorkasky handed him a letter of appreciation from affiliate organization NAEVR for his leadership as Ranking Member of the Health Subcommittee of the House Energy and Commerce Committee in championing the 21st Century Cures Act legislation, which authorizes $1.5 billion annual increases for the National Institutes of Health (NIH) in Fiscal Years 2016-2018 and establishes a new Innovation Fund at $2 billion per-year for FYs 2016-2020.

Janine Austin Clayton, M.D., a board-certified ophthalmologist and National Institutes of Health (NIH) Associate Director for Research on Women’s Health and Director of its Office of Research on Women’s Health, also provided a welcome, relating how her experience with patients with autoimmune ocular diseases sparked her interest in the role of sex and gender in health and disease. Dr. Clayton formerly served as the Deputy Clinical Director for the National Eye Institute (NEI) and is a founding member of co-sponsor organization Women in Ophthalmology. In 2009, she spoke at Vision 2020 USA’s World Sight Day Congressional Briefing about women bearing a disproportionate burden from eye disease.

Dr. Holland prefaced his talk by noting that it was a diagnosis of uveitis that alerted doctors that Ian Crozier, M.D., an American who had been treated for and apparently “cured” of Ebola, still had active virus inside the eye. He continued by describing inflammatory eye disease as that which can occur in any part of the eye, including its wall (sclera), the clear front surface (cornea) and the optic nerve-all of which can lead to severe, sight-threatening complications including glaucoma, cataracts, and scarring. Although uveitis specifically refers to inflammation of the “uvea,” which is the layer between the sclera and retina (light sensitive membrane at the back of the eye) that contains most of the eye’s blood vessels, in practical terms it is the designation given to inflammation of any structure inside the eye. Uveitis is not a specific disease, but is a category of diseases with many causes and clinical presentations, the common denominator of which is intraocular inflammation.

Although inflammation can be caused by infection from myriad infectious diseases, including syphilis and tuberculosis, it is most often non-infectious in origin. It can be autoimmune in nature, it can be caused by trauma, and it can be the side-effect of medications. Uveitis can be isolated to the eye or it can be one of many problems caused by systemic diseases, such as various forms of arthritis, as well as inflammatory diseases of the kidneys, gastrointestinal tract, and lungs, and even multiple sclerosis. In some cases, uveitis will be acute, meaning that it is sudden in onset with complete resolution after a course of treatment. However, in the majority of cases, inflammation will be recurrent or chronic, necessitating continued treatment. Symptoms can include eye pain and sensitivity to light.

An estimated 2.3 million Americans have uveitis, with up to 30,000 new cases occurring each year. One out of every 1,000 Americans will have active uveitis at any given time, and it accounts for 10 percent of the 2.8 million people blinded in the United States. Although classified as a “rare disease,” its impact is substantial, accounting for an estimated $243 million in annual costs in the U.S., with $91 million of that in direct medical costs. Uveitis can occur at any age, and although its incidence increases in older populations, it can affect children/young adults in their most productive years-meaning that it has a disproportionally greater impact on society than some common eye diseases that occur predominantly in older individuals. Women, who have an increased risk of autoimmune diseases, tend to be at greater risk of developing chronic forms of uveitis, and some forms are also more common in racial and ethnic minorities-African-Americans have a higher incidence, and recent studies suggest that Hispanics have a significantly higher risk of ocular toxoplasmosis, the most common form of infectious uveitis that involves the retina.

Current uveitis treatments, designed to eliminate infection or suppress autoimmune inflammation on a long-term basis, are often expensive, inconvenient, and incompletely effective. Many have intolerable side-effects for some patients. These problems emphasize the need for new treatments, yet development of better drugs will require an improved understanding of disease processes associated with uveitis. The NEI has supported a number of initiatives/studies to investigate various aspects of uveitis cause, incidence, and treatment, including:

• Since 2012, a Human Ocular Immunology Agreement with the United Kingdom that studies uveitis/immune-related eye diseases, shares advances, and recruits patients for joint clinical trials.
• Funding for international, multicenter clinical trials by the Multicenter Uveitis Steroid Treatment (MUST) Research Group, which have compared the efficacy and safety of currently available treatments for uveitis and its complications.
• Participation in a March 2015 joint NEI/Food and Drug Administration (FDA) Workshop on Clinical Trial Endpoints for Inflammatory Eye Disease which brought together researchers, clinicians, and industry to discuss better methods for assessing the effects of new therapies for chronic, non-infectious uveitis.

At the Endpoints Symposium, researchers identified several goals for future studies of inflammatory eye diseases, such as:

• Standardized methods for assessment of disease and response to treatment that can be used in clinical trials for new therapies undergoing regulatory review by the U.S. Food and Drug Administration (FDA) and international regulatory bodies.
• Development of automated methods for quantifying intraocular inflammatory reactions that move beyond the current subjective methods. Examples include laser flare photometry, which quantifies protein levels in ocular fluids using a scanning laser, and Optical Coherence Tomography (OCT), non-invasive three-dimensional imaging that not only can measure retinal swelling but can also count cells in the eye’s anterior chamber-and can quantify vascular leakage from the retina.
• A better understanding of the immune processes involved in disease pathogenesis, including the genetic basis, which can assist in accounting for the variation in incidence and severity between different groups.

 

The following organizations co-sponsored the Briefing: Research to Prevent Blindness American Uveitis Society Association for Research in Vision and Ophthalmology Women in Ophthalmology Women’s Eye Health American Autoimmune Related Diseases Association Sjögren's Syndrome Foundation Society for Women’s Health Research

 

 

Brion Raymond (XOMA Corporation) with J. Michael Quinlan, a Board member of the American Autoimmune Related Disease Association, a briefing co-sponsor

After the Briefing, Dr. Holland met with Cong. Ted Lieu (D-CA) to describe his research