Topical application of the rheumatoid arthritis drug Kineret (anakinra, Amgen) effectively treats the symptoms of dry eye disease, according to a study in the April 18 online edition of JAMA Ophthalmology.

Previous research has shown that dry eye is associated with a significant overexpression of inflammatory cytokines, including interleukin 1 (IL-1). Anakinra, an IL-1 receptor antagonist, effectively suppresses IL-1-mediated inflammation at the level of the ocular surface. 

In this randomized, double-masked study, the researchers assessed the safety and efficacy of topical anakinra in 75 individuals with dry eye disease secondary to meibomian gland dysfunction. The subjects were randomized to receive TID administration of 2.5% anakinra, 5.0% anakinra or artificial tears for 12 weeks.

The primary study outcomes included measurement of corneal fluorescein staining (CFS), complete bilateral CFS clearance, tear film break-up time, meibomian gland secretion quality and dry eye-related symptoms (i.e., ocular grittiness, light sensitivity or blurred vision).

After 12 weeks of dosing, subjects who used 2.5% anakinra were four times more likely to exhibit a bilateral reduction in CFS compared to those who received artificial tears. Further, the researchers found that those dosed with 2.5% anakinra experienced a six-fold decrease in dry eye-related symptoms compared to subjects who used artificial tears.

“We began looking at the possible therapeutic effects of IL-1 receptor agonists over 10 years ago in my laboratory,” says senior author Reza Dana, MD, MSc, MPH, professor of ophthalmology at Harvard Medical School.  But, “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. 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,” Dr. Dana added. 

Amparo F, Dastjerdi MH, Okanobo A, et al. Topical interleukin 1 receptor antagonist for treatment of dry eye disease: A randomized clinical trial. JAMA Ophthalmol. 2013 Apr 18:1-9. [Epub ahead of print]