By Lynda Williams, Senior medwireNews Reporter
Clinical trial results point to a role for interleukin (IL)-1 targeted agents for the treatment of dry eye disease (DED) associated with meibomian gland dysfunction.
The study, published in JAMA Ophthalmology, demonstrates a significant benefit for patients with refractory DED who were randomly assigned to use the topical IL-1 receptor antagonist anakinra compared with patients given vehicle (carboxymethylcellulose 1%) alone.
After 12 weeks of treatment, the 30 patients given anakinra 2.5% achieved on average a 46% reduction in their corneal fluorescein staining (CFS) score, giving a significant improvement from baseline and compared with vehicle alone.
The 15 patients given anakinra 5% achieved a 17% reduction in CFS score but this did not significantly differ from baseline or the 19% CFS reduction achieved by the 30 vehicle-treated patients.
At the 12-week assessment, complete bilateral CFS clearance was achieved by 29% of the 28 patients given anakinra 2.5% compared with just 7% of 15 patients given anakinra 5.0% or 29 patients given vehicle.
In addition, patients given anakinra 2.5% or 5.0% reported improvements in symptoms from week 2 of treatment, with significant benefits over vehicle achieved by both groups by week 6. At 12 weeks, dry eye symptoms had significantly reduced by 30% for patients given anakinra 2.5%, and by 35% for patients given anakinra 5.0% compared with just 5% for controls.
Patients given anakinra 2.5% also achieved a significant decrease in the three subscales of the Ocular Surface Disease Index compared with vehicle-treated patients, while those given anakinra 5.0% had significant benefits in two of the three subscales.
None of the patients experienced serious ocular or systemic side effects of treatment, and microbial test results did not significantly differ between the three treatment groups, report Reza Dana (Massachusetts Eye and Ear Infirmary, Boston, USA) and co-authors.
"The results of this study provide proof-of-concept support for the therapeutic efficacy of topical IL-1 blockade in ameliorating the signs and symptoms of DED," the team concludes.
"To our knowledge, the topical use of a protein-based biologic agent in treatment of DED is unprecedented. The promising results from this study may herald a new era of highly targeted topical molecular treatments in treating ocular surface diseases."
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