SBIR-STTR Award

The exponential increase of diabetics and the elderly in the U.S. has at least tripled cataract surgeries in just two decades. As many as half of these surgeries will lead to posterior capsular opacification (PCO), which requires follow-up surgery using Nd:YAG laser capsulotomy. Without this additional surgery, patients can suffer permanent vision loss. In many countries laser capsulotomy is not available, and PCO results in blindness. PCO is the number one complication of cataract surgery, and has resulted in > $250 million in annual costs for the U.S. Medicare system alone. Costs will exceed $1 billion by 2050. PCO adds patient care and cost burden beyond the cataract surgery itself. The number of diagnosed diabetics in the U.S. has far out-paced predictions, and this group experiences high rates of cataract formation, with more-difficult recovery from surgery. As the aging population requires more of these surgeries and diabetes becomes an epidemic, costs will escalate significantly. Clearly, PCO procedures are a significant patient care problem and are escalating healthcare costs. PCO is not even an option in many parts of the world, where patients experience vision loss due to lack of resources. It is thus important to eliminate the need for PCO. Ideally, no follow-up surgery would be required after the initial cataract removal. PCO results from attachment/migration of lens epithelial cells (LECs) behind the intraocular lens (IOL). These cells cause the opacification of the posterior lens capsule that impairs vision and requires follow up laser therapy. An IOL that eliminates PCO would eliminate the need for laser capsulotomy-greatly reducing associated risks and costs. The ideal device would not use potentially harmful pharmacologic agents that can result in inflammation or other complications. Sharklet Technologies Inc. proposes to develop a new device designed to inhibit LEC attachment/migration behind the IOL, and to team with industry to market the device in the U.S. and worldwide. The device is a Sharklet-patterned membrane (PM) integrated onto an IOL. Made of the same material as the IOL, the PM provides two critical support elements: a square edge that prevents equatorial LECs from migrating along the posterior surface of the capsular bag, and the Sharklet pattern that further inhibits attachment and migration of LECs from the periphery of the capsular bag into the visual axis. The overall project goal is to validate, prototype, and pre-manufacture the PM/IOL integrated device, with validation of the PM concept in Phase I and integration of the PM/IOL during Phase II. Phase I goals are to 1) establish proof-of-concept that the Sharklet pattern reduces the mechanisms of LEC attachment and migration via in vitro testing with LECs, and 2) validate that the PM reduces PCO in vivo in rabbit eyes. Sharklet's preliminary data and expert, multi-disciplinary team sets the stage for a successful Phase I proof-of- concept project designed to lead to Phase II work focused on PM/IOL integrated prototype suitable for pre- manufacturing studies and testing in a statistically powered animal study prior to clinical studies in Phase III.

Public Health Relevance Statement:


Public Health Relevance:
A serious complication of cataract surgery, called "secondary cataract," occurs in 25% to 50% of cataract surgeries, requiring follow-up laser surgery that represents an additional risk to patients and over $300 million in added medical costs per year in the U.S alone. Sharklet Technologies, Inc. proposes to develop a novel micro-patterned membrane designed to be integrated into a next-generation intraocular lens that has added functionality to prevent secondary cataract formation. Based on the success of this multi-phase SBIR project, the novel device we envision is expected to have a significant impact on improving patient care worldwide and reducing healthcare costs, which are rising steadily in the U.S. due to growing patient populations with increased cataract susceptibility.

Project Terms:
Address; aging population; Aluminum; Animals; base; Biological Assay; Blindness; Capital; Cataract; Cataract Extraction; cell motility; Cell-Matrix Junction; Cells; Clinical Research; clinically relevant; commercialization; Complication; cost; Country; Data; design; Device Designs; Devices; Diabetes Mellitus; diabetic; Diagnosis; Elderly; Elements; Endothelial Cells; Epidemic; Epithelial Cell Proliferation; Epithelial Cells; Excision; experience; Eye; follow-up; Goals; Health Care Costs; Human; Impairment; Implant; improved; In Vitro; in vitro testing; in vivo; In-Migration; Incidence; Industry; industry partner; Inflammation; innovation; Intraocular lens implant device; Intraocular Lens Implantation; Laser Surgery; Lasers; Lead; lens; Lens (device); lens capsule; Letters; Low-Level Laser Therapy; Manufacturer Name; Marketing; Medical; Medicare; Membrane; Methods; Metric; Microscopic; migration; Modeling; Neodymium; next generation; novel; operation; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Pathogenesis; Patient Care; patient population; Patients; Pattern; Phase; Population; Predisposition; prevent; Procedures; prototype; public health relevance; Publishing; Recovery; Relative (related person); Research; Resources; Risk; safety study; Small Business Innovation Research Grant; Solutions; Staging; success; Surface; System; Techniques; Technology; Testing; Text; Tissues; Validation; Vision; Visual; Visual impairment; Work; yttria; Yttrium

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.

Public Health Relevance Statement:


Public Health Relevance:
A serious complication of cataract surgery, called "secondary cataract," occurs in 25% to 50% of cataract surgeries and requires follow-up laser surgery that represents an additional risk to patients and over $250 million in added medical costs per year in the U.S alone. Sharklet Technologies proposes to develop a next- generation intraocular lens that has a novel protective membrane design incorporating a micro-patterned surface to ultimately prevent secondary cataract formation. Successful results of this SBIR project, will enable commercialization of a device envisioned to have a significant impact on improving patient care worldwide and reducing healthcare costs, which are rising steadily in the U.S. due to growing patient populations with increased cataract susceptibility.

NIH Spending Category:
Aging; Eye Disease and Disorders of Vision; Prevention

Project Terms:
Aluminum; American; Animals; Area; base; Blindness; Businesses; Capital; Cataract; Cataract Extraction; cell motility; Cells; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; commercialization; Complication; cost; Country; Data; design; Developing Countries; Development; Devices; diabetic; Diagnosis; Elderly; Ensure; Epithelial Cells; Europe; Excision; experience; Eye; Feedback; follow-up; Goals; haptics; Health; Health Care Costs; Healthcare Systems; Human; Impairment; Implant; improved; In Vitro; Incidence; industry partner; Inflammation; Intraocular lens implant device; Laser Surgery; Lasers; Lead; lens; Lens (device); lens capsule; Letters; Life; Manufacturer Name; Marketing; Medical; Medicare; meetings; Membrane; Microscopic; migration; Modeling; Modification; Neodymium; next generation; novel; operation; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Outcome; Patient Care; patient population; Patients; Pattern; performance tests; Phase; phase 1 study; Phase II Clinical Trials; Population; Predisposition; prevent; Prevention; Procedures; Production; public health relevance; Recovery; Regulation; research clinical testing; Research Design; Resources; restoration; Risk; Safety; skills; Small Business Innovation Research Grant; Staging; Stress; success; Surface; System; Techniques; Technology; Test Result; Testing; trend; Validation; Vision; Vision Disorders; Visual; Visual impairment; Work; yttria; Yttrium