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

这个小型企业创新研究(SBIR)第一阶段项目具有更广泛的影响/商业潜力，通过根据每个患者的疾病进展量身定做眼压，从而实现更有效的青光眼治疗。2015年，美国青光眼市场估计超过20亿美元，我们的潜在市场--青光眼手术疗法--估计为5.34亿美元。青光眼的发病率随着年龄的增长而增加，随着婴儿潮一代人口年龄的增长，青光眼治疗的需求将会越来越大。为了治疗青光眼，患者将接受终身药物治疗、多次激光手术和侵入性手术。然而，即使有了所有这些治疗选择，青光眼患者仍然会因为青光眼而失明。我们治疗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一位患者的视力保护。拟议的项目将证明第一个外部青光眼引流装置的可行性，以调整和设置眼睛的压力。青光眼是导致不可逆性失明的主要原因，只能通过降低眼压来治疗。手术治疗是不可预测的，成功率不佳主要取决于引流部位的选择。这种新颖的装置会引流到眼睛的一个新区域，以避免与目前的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求，通过微调压力，为数百万青光眼患者提供首次个性化治疗。初步研究表明，该装置的安全性和可行性；但可更换部件的可定制化和可调整性仍有待调查。因此，这一阶段的研究项目将测试和优化设备中的可更换部件，并确定生物结垢的风险。能够安全、可靠和可预测地设定稳定的压力将是青光眼治疗的一大进步。

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.