Dry Eye Syndrome

The Disease: Dry Eye Syndrome (DES) is a condition that includes a variety of disorders resulting in loss or breakup of the natural tear film, which lubricates and maintains the surface of the eye. Without this tear film, vision is impaired, the ocular surface may be damaged, and patients may suffer severe ocular discomfort. DES can be caused by a variety of conditions including excessive tear evaporation and a reduction of tear production in the lacrimal gland, where tears are produced. Though the exact causes of this condition are unknown, there is evidence supporting the link between reduced tear production and chronic inflammation of the ocular surface and lacrimal gland.

Though there are a variety of medications that palliate the symptoms of DES, there is still no cure for this debilitating disease. Currently available medications for DES leave substantial room for more effective and better-tolerated products. Lux Biosciences is developing LX214, a proprietary, clear, mixed nanomicellar formulation of voclosporin for the treatment of dry eye syndrome and potentially other chronic inflammatory ocular diseases. A Phase 1 study for LX214 in the dry eye indication was completed in 2009.

The Market Opportunity: Symptoms associated with Dry Eye Syndrome account for up to 40% of all ophthalmologist visits. Associated autoimmune diseases, LASIK surgery, or menopause may contribute to the disease, which affects some 10 million patients in North America and Europe. Approximately one-third of patients are affected by severe disease and two-thirds by mild and moderate disease. A sub-segment of patients are affected by Sjögren’s syndrome, which is an autoimmune disease typically affecting the eye (dry eye), epithelial tissues in the mouth (dry mouth), and joints; Sjögren’s Syndrome affects at least 1% of the population.

The sheer number of patients coupled with the dearth of treatment options suggests that the market opportunity is very large.

In addition, given the heterogeneity of the syndrome and the large patient population, a segmentation of this market may best serve patient needs. A topical eye drop product would address treatment requirements for the mild to moderate forms of the disease, while a long-term delivery system would potentially be suited to the more severe forms of the disease. Lux Biosciences is actively pursuing both product concepts.