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

SBIR 第二阶段：外部分流器内的可调眼压控制

• 批准号: 1555923
• 负责人: Lucinda Camras
• 金额: $ 71.32万
• 依托单位: Camras Vision, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-03-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1555923&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Adjustable; Eye

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.

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力允许通过根据每位患者的疾病进展调整眼压来进行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，我们的目标市场青光眼手术治疗估计为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的老龄化，对青光眼治疗的需求将不断增长。为了治疗青光眼，患者经历终身药物治疗方案、多次激光手术和侵入性外科手术。然而，即使有所有这些治疗选择，青光眼患者仍然会因青光眼而失明。所提出的新颖设计和青光眼治疗方法将为患者提供个性化治疗，并消除对大量昂贵手术的需求。最重要的是，青光眼治疗的个性化将优化每位患者的视力保护。拟议项目将验证青光眼引流装置的安全性和有效性，以调整和设置眼睛中的压力。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，次优成功率主要取决于引流部位的选择。所提出的新型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。该设备还可以通过根据患者一生的需求微调压力，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，该器械具有可调节组件的可行性。 然而，其有效性和安全性还有待充分研究。因此，在本次II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。