Proposal Title Enhancing the Market, Regulatory, and Intellectual Property Aspects of a Novel Intraocular Pressure Monitoring System
Category Human Health and Development
Abstract Brockman-Hastings seeks to reduce vision loss for glaucoma sufferers by creating a simple, accurate, and clinically acceptable system for monitoring intraocular pressure (IOP). Elevated IOP remains the key risk factor and treated symptom for glaucoma; however, single point measurements in an ophthalmologist’s office are often insufficient to fully manage the disease or assess the effectiveness of treatments. To address this problem several research groups have developed implantable IOP sensors; however, these devices have thus far proven too large, complex, inaccurate, and/or high risk for rapid clinical adoption. In contrast, Brockman-Hastings’ sensor does not include any implanted microelectronic circuitry or external or internal power sources. Instead, a small readout unit captures an infrared image of the sensor to measure IOP. The simplicity of our device minimizes its physical size, providing for an aesthetic implant and allowing a simple, lower-risk implantation procedure. In Phase I we established feasibility of the technology by achieving both specific aims: (1) sub-1 mmHg sensing accuracy in a simulated physiological environment and (2) sub 2-mmHg precision and one-month tolerability in the rabbit eye. The specific aims for our federally funded Phase II effort are (1) Demonstrate that the system meets preclinical performance requirements under real-time, accelerated aging, and in-vivo conditions, and (2) Demonstrate that the system satisfies preclinical safety requirements. Efforts supported by Kentucky SBIR matching funds target three additional objectives: (1) Enhance market and regulatory positions with a 2nd generation prototype; (2) Enhance regulatory position with an expanded FDA strategy; and, (3) Enhance intellectual property position with focused patent strategy. Successful commercialization of this system will reduce the human and financial cost of glaucoma-related vision loss by providing physicians with accurate, long-term IOP data on which to base treatment decisions and assess treatment effectiveness.
Amount Awarded $312,500
Keywords ophthalmology, glaucoma, intraocular pressure, medical device, optical sensors
Point of Contact Jeffrey Todd Hastings
[email protected]
Brockman Hastings
Location Louisville
Fayette County