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Dry Eye Disease The International Dry Eye Workshop defines dry eye as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface" Lemp, 2007* Symptoms of dry eye disease include burning, itching, irritation, photophobia, a feeling that there is a foreign body in the eye, and at times thick mucus deposits that can cause blurred vision. If left untreated, it can cause permanent damage, including impaired vision. The most common causes of "dry eye" are:
• other systemic diseases or medications that disrupt normal tear secretion and blinking • a decrease in supportive factors (such as androgens – male sex hormones) • environmental factors, dust, and pollutants Sjögren’s syndrome is a chronic disease in which white blood cells attack the moisture producing glands. The hallmark symptoms are dry eyes and dry mouth, but it is a systemic disease, affecting many organs and may cause fatigue. It is one of the most prevalent autoimmune disorders, striking as many as four million Americans. Dry eye disease is one of the most common reasons that a patient visits an ophthalmologist. In 2003, the estimated prevalence of dry eye syndrome in the United States was 5.5 million diagnosed cases. Most sufferers are women and prevalence increases with age. More than 90% Sjögren’s syndrome sufferers are women and the average age of onset is in the late 40’s. Sjögren’s syndrome is believed to affect 1 to 3 million Americans. Due to the limited number of therapies for the treatment of dry eye, the symptoms are also commonly relieved with over-the-counter artificial tears (saline solution) as a purely palliative therapy to lubricate the eyes. Achieving significance in both an objective and a subjective endpoint in clinical studies has historically been a challenge for new drug candidates for the treatment of dry eye disease. Currently, there are no FDA-approved therapies for the treatment of dry eye disease per se. Rather, prescription products on the market or currently in development in the US aimed at the treatment of dry eye disease are segmented into two categories; anti-inflammatory medicines focused on alleviating the inflammatory component of dry eye and secretagogues focused on stimulating tear secretion. Anti-inflammatory drugs are most applicable for the severe dry eye segment (10% of the dry eye patient population). However, both ophthalmic products in Lantibio's development pipeline, Rejena, 0.18% (sodium hyaluronate ophthamic solution) and lancovutide ophthalmic solution, represent new classes of compounds in development for the treatment of dry eye disease in the US.
* Lemp MA, Baudouin C, Baum J, et al. DEWS Definition and Classification Subcommittee of
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