Micro Patterned Intraocular Lens Membrane for Reducing Incidence of PCO

 描述(申请人提供)：美国糖尿病患者和老年人的指数增长在短短20年内使白内障手术的数量增加了两倍多。其中多达一半的手术将导致后囊混浊(PCO)，这需要后续的Nd：YAG激光囊膜切开术。如果没有这个额外的程序，患者可能会遭受永久性视力丧失和残疾。在许多国家，激光囊膜切开术是不可用的，后囊混浊会导致失明。作为白内障手术的主要并发症，PCO仅在美国医疗保险系统每年就导致2.8亿美元的成本。预计到2050年，成本将超过10亿美元。美国确诊糖尿病患者的数量远远超出了预期。这组患者的白内障形成率较高，手术后恢复较困难。如果目前的趋势继续下去，到本世纪中叶，多达三分之一的美国人可能患有糖尿病，这将给我们的医疗体系带来越来越大的财务压力。据估计，世界上90%以上的视障人士生活在发展中国家，后续的激光囊膜切开术在这些地区很少有选择；因此，患者由于缺乏资源而经历视力丧失和/或失明。因此，在全球范围内根除PCO非常重要。理想情况下，在最初的白内障摘除后不需要后续手术。消除后发性白内障的人工晶状体将极大地降低与白内障手术相关的健康风险和成本。理想的装置不会使用可能导致炎症或其他并发症的潜在有害药理物质。PCO是晶状体上皮细胞(LECs)向人工晶状体(IOL)后方迁移的结果。这些细胞导致晶状体后囊膜混浊，损害视力。Sharklet Technologies建议继续开发下一代IOL，以防止PCO，并与一家行业合作伙伴合作，在美国和全球销售这种设备。这种有膜保护的人工晶状体，ClearSight IOL，将在眼球周围区域使用鲨鱼图案进行修改。ClearSight IOL提供了两个关键功能：1)保持囊袋扩张并防止赤道LEC沿囊袋后表面迁移的双正方形边缘；2)Sharklet图案，进一步抑制LEC向视轴的迁移。我们的I期SBIR研究超过了里程碑，显示在统计上显著减少了LEC在体外的迁移(减少了80%)和在兔体内的PCO(减少了100%的视觉意义上的PCO)。第二阶段的目标是制造ClearSight人工晶状体和伴随的注射器，验证这些设计的安全性和有效性，并在第二阶段结束前提交ClearSight人工晶状体人类临床研究的研究设备豁免管理包。第一阶段的成功及其专家、多学科团队的广泛技术和商业技能为成功的第二阶段制造和验证项目奠定了基础，该项目旨在与第三方投资者或行业合作伙伴合作进行第二阶段后的临床试验。

 DESCRIPTION (provided by applicant): The exponential increase of diabetics and the elderly in the U.S. has more than tripled the number of cataract surgeries performed in just two decades. As many as half of these surgeries will lead to posterior capsular opacification (PCO), which requires follow-up Nd:YAG laser capsulotomy surgery. Without this additional procedure, patients can suffer permanent vision loss and disability. In many countries laser capsulotomy is not available, and PCO results in blindness. As the primary complication of cataract surgery, PCO results in >$280 million in annual costs for the U.S. Medicare system alone. Costs are expected to exceed $1 billion by 2050. The number of diagnosed diabetics in the U.S. has far out-paced predictions. This group experiences high rates of cataract formation with more difficult recovery from surgery. If current trends continue, as many as one out of three Americans could be diabetic by mid-century, which will place increasing financial stress on our healthcare system. It is estimated that over 90% of the world's visually impaired are living in developing countries and follow-up laser capsulotomy surgery is rarely an option in these areas; therefore, patients experience vision loss and/or blindness due to lack of resources. It is thus important to eradicate PCO globally. Ideally, no follow-up surgery would be required after the initial cataract removal. An IOL that eliminates PCO would greatly reduce health risks and costs associated with cataract surgeries. The ideal device would not use potentially harmful pharmacologic agents that can result in inflammation or other complications. PCO results from migration of lens epithelial cells (LECs) behind the intraocular lens (IOL). These cells cause the opacification of the posterior lens capsule that impairs vision. Sharklet Technologies proposes to continue development of a next-generation IOL that will prevent PCO, and to team with an industry partner to market the device in the U.S. and worldwide. This membrane-protected IOL, the ClearSight IOL, will be modified with the Sharklet pattern on the area surrounding the optic. The ClearSight IOL provides two key features: 1) a dual square edge that maintains capsular bag expansion and prevents equatorial LECs from migrating along the posterior surface of the capsular bag, and 2) the Sharklet pattern that further inhibits migration of LECs into the visual axis. Our Phase I SBIR studies exceeded milestones, demonstrating statistically significant reduction in LEC migration in vitro (80% reduction) and PCO in rabbits (100% reduction in visually significant PCO). Phase II goals are to manufacture ClearSight IOLs and an accompanying injector, validate the safety and efficacy of these designs, and submit a regulatory package for an Investigational Device Exemption for human clinical studies on the ClearSight IOL by the end of Phase II. Phase I success and the broad-based technical and business skills of its expert, multi-disciplinary team sets the stage for a successful Phase II manufacturing and validation project designed to lead to post- Phase II clinical trials in collaboration with a third-party investor or industry partner.