Research Project
9241166
Abstract: 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 >$350 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. 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. The market is continually seeking improvements in IOL materials, especially in elimination of glistenings that cause decreased contrast sensitivity and result in loss of vision quality. This ClearSight IOL will be the first IOL to thus provide truly clear vision via three key features: 1) an outer ring and membrane that maintain capsular bag expansion and prevent equatorial LECs from migrating along the posterior surface of the capsular bag, 2) the Sharklet pattern that further inhibits migration of LECs into the visual axis, and 3) a novel material formulation that is free of glistenings. 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). We are making rapid progress in our Phase II project to manufacture ClearSight IOLs and an accompanying injector and validate the safety and efficacy of these designs in anticipation of submitting a regulatory package for an Investigational Device Exemption for human clinical studies on the ClearSight IOL. Phase I and II success and the broad-based technical, clinical, and business skills of our expert, multi-disciplinary team sets the stage for a successful commercialization project to complete pilot clinical studies and obtain a CE Mark for our device, allowing us to move into post-market studies to support regulatory approval in the U.S.
