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Nancy McNamara, OD, PhD with Jes Kristen Klarlund, PhD Associate Professor School of Optometry The Regents of the University of California, Berkeley A New Generation of Eye Drops to Treat the Ocular Manifestations of Sjögren’s Syndrome Research Description: Sjögren’s Syndrome is commonly associated with severe dry eye that is debilitating and highly recalcitrant to current therapies. A number of protein drugs are known to suppress inflammation that causes dry eye, but they have little or no effects when applied as eye drops because they are washed out quickly by the tear flow and therefore have little or no effect. We are proposing a new method to produce eye drops that allow proteins to remain at the surface of the eye for up to 16 hours and consequently have time to act. We will test a therapeutic protein, Anakinra, which is effective in treating other inflammatory diseases such as rheumatoid arthritis, in a mouse model of Sjögren’s Syndrome with the modified eye drops. The technology is very versatile and will allow using therapeutic proteins to address other eye-related problems in Sjögren’s Syndrome such as corneal haze, pain, and insufficient secretion of tears. Scientific Abstract: Dry eye is an onerous manifestation of Sjögren’s Syndrome (SS), and there is a great unmet need to develop effective therapies. The short residence time on the ocular surface greatly limits the efficacy of most potential topical ophthalmic therapeutics. We propose to develop a novel drug delivery system that allows proteins to be administered as eye drops and preliminary data show that proteins can remain active at the ocular surface for at least 16 hours. We have previously documented that the knock-out mouse for the autoimmune regulator (AIRE) gene is an excellent model for Sjögren’s Syndrome that develops severe dry eye. Anakinra is an interleukin-1 antagonist that is used clinically to reduce inflammation in several autoimmune diseases, and we will analyze its ability to reduce inflammation in corneas of AIREdeficient mice. The delivery system is very versatile and can be used to deliver other bioactive proteins for instance to enhance innervation, to counter opacification, and to support the physical integrity of the cornea in SS.