The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Aramis Biosciences’ immunomodulatory agent, A197, for the treatment of dry eye disease.  Dry eye disease is a common, chronic, immune-mediated disease that is driven and perpetuated by pro-inflammatory T helper cells that results damage to epithelial cells and causes ocular discomfort. The disease is further associated with a number of risk factors, some of which include advanced age, autoimmune disorders, diabetes, and certain environmental factors such as pollution. Immunomodulatory agents, such as A197, are designed to suppress or stimulate the immune system, helping the body to fight off disease, cancer, and infection more effectively. The IND approval will allow Aramis Biosciences to proceed to Phase II proof of concept clinical trial for their new topical immunomodulatory agent. Current treatments for dry eye disease include medications to reduce cornea and eyelid inflammation, as well as using cholinergic medication to help stimulate tear production. Aramis Biosciences is an immuno-ophthalmology biopharmaceutical company that develops disease-modifying therapies for ocular surface diseases.

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