Research Project
9306466
? 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.
