OHSU Part of Study That Finds Drug to Treat Potentially Blinding Eye Disease
05/11/09 Portland, Ore.
If approved by the FDA, the drug will be the first oral drug for events
The largest clinical trials ever conducted for uveitis, a group of inflammatory eye diseases, has found the first drug that significantly reduces both inflammation and recurrence. Oregon Health & Science University researcher Jim Rosenbaum, M.D., presented the findings at the recent Association for Research in Vision and Ophthalmology (ARVO) conference.
Uveitis, or inflammation within the eye, is a term used to classify a group of autoimmune diseases. The disease often affects people younger than 40 and leads to years of vision loss roughly comparable to that caused by diabetes. It’s the fourth leading cause of blindness, yet remains frequently mistreated.
Currently, many patients with diagnosed uveitis take corticosteroids. A survey of U.S. ophthalmologists and rheumatologists found many of these patients are taking doses as much as 50 percent higher than recommended for an extended period of time. The steroids may help retain vision, but they have debilitating side effects, including cataracts, glaucoma, diabetes, heart disease, osteoporosis, weight gain, ulcers, and mood and sleep disorders.
The LUMINATE trials, sponsored by Lux Biosciences, tested the efficacy of LX211 (LUVENIQ), a next-generation calcineurin inhibitor. The drug was found to actively reduce the rate of inflammatory exacerbations by 50 percent at six months, compared with a placebo. The study results also show a safety profile for LX211 at the 0.4 mg/kg bid dose that suggests the experimental drug would be suitable for chronic use as the first oral treatment for this sight-threatening eye disease.
“If this drug is ultimately approved by the Food and Drug Administration (FDA), it will mean hope for patients who previously had no approved treatments and little faith a drug would be found to treat what is considered to be an ;orphan’ disease,” said Rosenbaum, a professor of medicine in the OHSU School of Medicine and vice-chairman of the Department of Ophthalmology at the OHSU Casey Eye Institute.
In the United States, about 1 person in every1,000 will develop some form of uveitis, and about 20 percent to 30 percent of these individuals will develop the severe, sight-threatening form.
The LUMINATE program, is the first ever randomized, double-masked, dose-ranging and placebo-controlled trials. LUMINATE consisted of three trials which enrolled a total of 558 individuals at 56 sites in seven countries.
Oregon Health & Science University is the state’s only health and research university, and Oregon’s only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.