SBIR Phase I:Feasibility of Adjustable Eye Pressure Control within an External Shunt

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project allows for a more effective glaucoma treatment by tailoring eye pressure based on disease progression for each patient. In 2015, the US glaucoma market is estimated to be over $2 billion and our addressable market, glaucoma surgical therapies, is estimated to be $534M. The incidence for glaucoma increases with age, and as the baby boomer population gets older, there will be a growing need for glaucoma treatments. To treat the glaucoma, patients will undergo lifelong drug regimens, multiple laser procedures, and invasive surgical procedures. However, even with all these treatment options glaucoma patients still go blind from glaucoma. Our novel design and approach to glaucoma will personalize the treatment for patients and remove the need for numerous and costly procedures. Most importantly, the personalization of glaucoma therapy will optimize visual protection for every patient. The proposed project will demonstrate the feasibility of the first external glaucoma drainage device to adjust and set pressure in the eye. Glaucoma is a leading cause of irreversible blindness and is only treatable by reducing eye pressure. Surgical treatments are unpredictable with suboptimal success rates based primarily on the choice of drainage site. This novel device drains to a new area of the eye to avoid the complications and unpredictability associated with the current glaucoma surgeries. The device also can provide the first-ever personalized treatment for millions of glaucoma suffers by fine-tuning pressure based on the needs of the patient throughout his or her lifetime. Preliminary studies have shown safety and feasibility of the device; however, the customizable and adjustability of replaceable component has yet to be investigated. Therefore, this Phase I research project will test and optimize the replaceable component within the device and determine the risk of biofouling. The ability to set a stable pressure safely, reliably, and predictably would be a major advancement in glaucoma treatment.