SBIR Phase II: Adjustable Eye Pressure Control within an External Shunt

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project allows for a more effective glaucoma treatment by adjusting 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 glaucoma, patients 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. The proposed 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 validate the safety and efficacy of a 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. The proposed 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 sufferers by fine-tuning pressure based on the needs of the patient throughout his or her lifetime. Phase I/IB studies have shown feasibility of the device with an adjustable component. However, its efficacy and safety have yet to be fully investigated. Therefore, in this Phase II research grant, we will optimize the device for safety and efficacy and perform the necessary preclinical testing according to FDA standards to further develop the product.