Protein-based IL-1 antagonist shows promise for dry eye

This prospective randomized study found that treatment of dry eye disease (DED) with topical anakinra, 2.5%, an interleukin (IL-1) antagonist, for 12 weeks was safe and significantly reduced symptoms and corneal epitheliopathy. To the authors’ knowledge, the topical use of a protein-based biologic agent in the treatment of DED is unprecedented. The results suggest that the use of an IL-1 antagonist may have a role as a novel therapeutic option for patients with DED.

Anakinra (Kineret; Amgen Inc.) is a recombinant version of human IL-1Ra approved for treatment of rheumatoid arthritis. It has been used off label to treat many conditions that involve IL-1–mediated inflammation and has been shown effective in treating DED in an animal model.

The current study was a phase 1/2 double-masked trial. Subjects included 75 patients with refractory DED randomized to topical anakinra, 2.5%, anakinra, 5% or vehicle (1% carboxymethylcellulose) three times daily for 12 weeks.

Topical anakinra was well tolerated compared with vehicle, with no reports of serious adverse reactions attributable to the therapy. Participants treated with anakinra, 2.5% showed a 46 percent reduction in mean corneal fluorescein staining (CFS) score, compared to 17 percent in those treated with anakinra, 5% and 19 percent in those treated with vehicle. Complete bilateral CFS clearance was noted in 29 percent of patients treated with anakinra, 2.5% vs. 7 percent of patients treated with vehicle.

By week 12, treatment with anakinra, 2.5% and 5% led to significant reductions in symptoms of 30 percent and 35 percent, respectively. Treatment with vehicle led to a five percent reduction in symptoms.