FDA Highlights by Bruce Sylvester – Researchers from the Massachusetts Eye and Ear, Harvard Medical School, and Brigham and Women’s hospital in Boston, Massachusetts report that topical anakinra, a recombinant version of human IL-1Ra FDA-approved for treatment of rheumatoid arthritis, significantly reduced dry eye disease (DED) symptoms in a new clinical trial.
The results appeared on April 18, 2012 in JAMA Ophthalmology.
“We began looking at the possible therapeutic effects of IL-1Ra over 10 years ago in my laboratory,” said Reza Dana, M.D., MSc., M.PH., senior author. “This clinical trial was a significant milestone in our research. The results clearly show us not only that we can possibly help the millions of people affected by dry eye disease worldwide, but that biologics such as this have the potential to provide targeted therapies for other ocular ailments, as well.”
Prior studies showed that DED is associated with significant overexpression of inflammatory cytokines, including interleukin 1 (IL-1), in the eye.
In the 16-week study, the investigators randomized 75 subjects in a 2:2:1 ratio to receive eye lubricant (artificial tear), 2.5% of anakinra or 5% of anakinra, respectively.
Anakinra was well tolerated and was significantly more effective than the eye lubricant in improving the signs and symptoms of DED. Anakinra at 2.5% was four times more likely than the eye lubricant to bilaterally eliminate corneal staining, a measure of ocular surface disease.
Topical anakinra reduced dry eye symptoms statistically significantly and six times more effectively than the eye lubricant. Also, termination of anakinra (but not the lubricant) application at week 12 was followed by a trend toward increased symptoms between weeks 12 and 16, confirming the efficacy of the drug.
“We have never seen results such as this before in a trial to treat dry eye disease. We possibly have found a safe, well tolerated eye drop that can treat the underlying cause of dry eye rather than just temporarily mask the symptoms. We are excited about the positive results we saw in the data and with our patients who found relief in their symptoms and were able to return to some of their normal daily activities,” Dr. Dana said.