SBIR Phase II: Nanotechnology-Enabled Implant for Controlling Intraocular Pressure

Avisi Technologies, Inc, Redwood City CA

Investigators

Abstract

The broader impact of this Small Business Innovation Research (SBIR) Phase II Project is an improved treatment for patients suffering from glaucoma. Glaucoma is the leading cause of irreversible blindness, affecting 3.4 million Americans and 80 million people worldwide. The global glaucoma surgery devices market will reach $1.74 billion by 2024, increasing at a compound annual growth rate of 20%. In the U.S., glaucoma incurs over $4 billion in medical and societal costs annually. For patients with glaucoma, elevated eye pressure must be lowered to prevent optic nerve damage. However, conventional surgical implant treatments are bulky, highly invasive, and cause chronic discomfort. Newer, smaller devices are less invasive but affect long-term efficacy as they inadequately sustain lower eye pressure when scarring occurs. This project will develop an implant many times thinner than a human hair to safely reduce eye pressure while minimizing patient discomfort and failure from scarring. The device will facilitate patient comfort and surgical ease through a combination of mechanical and materials engineering. Beyond glaucoma, the technology will play a key role in future permanent and efficacious ocular implants - a rapidly growing component of vision care. This Small Business Innovation Research (SBIR) Phase II project continues development of an ultrathin implant to treat glaucoma. Specifically, this project will optimize a novel corrugated microstructure with a unique combination of mechanical and fluid flow properties. These characteristics provide the implant with stiffness required for handling, flexibility to conform to soft eye tissues, and flow properties for controlling intraocular pressure. Devices will be fabricated using improved micro-electromechanical systems (MEMS) methods and validated on a new instrument designed to evaluate flow resistance. This project will conduct biocompatibility, toxicology, and performance studies, monitoring intraocular pressure, levels of inflammation, adverse events, and implant stability. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.