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

这项小企业创新研究（SBIR）二期项目具有更广泛的影响/商业潜力，可以根据每位患者的疾病进展调整眼压，从而实现更有效的青光眼治疗。2015年，美国青光眼市场预计将超过20亿美元，而我们的青光眼手术治疗市场预计将达到5.34亿美元。青光眼的发病率随着年龄的增长而增加，随着婴儿潮一代年龄的增长，对青光眼治疗的需求也会越来越大。为了治疗青光眼，患者需要终生服药、多次激光治疗和侵入性外科手术。然而，即使有了所有这些治疗方案，青光眼患者仍然会因青光眼而失明。提出的青光眼的新设计和方法将使患者的治疗个性化，并消除大量和昂贵的程序的需要。最重要的是，青光眼治疗的个性化将优化每个患者的视力保护。拟议的项目将验证青光眼引流装置调节和设定眼压的安全性和有效性。青光眼是导致不可逆失明的主要原因，只能通过降低眼压来治疗。手术治疗是不可预测的，次优成功率主要基于引流部位的选择。提出的新装置引流到眼睛的新区域，以避免与当前青光眼手术相关的并发症和不可预测性。该设备还可以根据患者一生的需要微调压力，为数百万青光眼患者提供有史以来第一次个性化治疗。I/IB期研究表明，该设备具有可调节组件的可行性。然而，其有效性和安全性尚未得到充分调查。因此，在这项二期研究资助中，我们将优化设备的安全性和有效性，并根据FDA标准进行必要的临床前测试，以进一步开发产品。

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.