Although there are ~300,000 to 600,000 individuals in the United States with active uveitis, there is no clinically accepted method for quantitative assessment of ocular flare that would result in rapid, non-invasive diagnosis of uveitis. Current methods of diagnosis for uveitis involve a thorough examination of the eye with a slit lamp microscope and ophthalmoscopy. Higher levels of flare in particular have been associated with poor visual outcomes in patients with certain forms of uveitis, such as uveitis associated with juvenile arthritis (Holland & Stiehm 2003)(Rosenberg et al. 2004). These tests are both time intensive and largely subjective (Kempen et al. 2008). The only FDA approved device that currently is able to provide an objective assessment of the degree of uveitis is the KOWA laser flare meter (FM-600); this is a bench top device that does not have the clinical sensitivity for diagnosing mild uveitis where early intervention is critical (Ladas e.t al. 2005). Furthermore, it s not suitable for cost effective widespread clinical use. To overcome this major health need, ChromoLogic LLC (CL), during Phase I, proposed, developed and validated a portable Ocular Flare meter (OFAM) - a non-invasive instrument platform that has shown promise in diagnosing disease and radiation induced blood eye barrier disruption in less than 1minute. Thorough in vitro and pilot animal (NHP) and clinical trials (N=100) has demonstrated the efficacy of the technology. The results also show sensitivities that far exceed the commercially available bench top KOWA product and good correlation with the currently used subjective scoring mechanism. Also during Phase I, the team submitted and negotiated the appropriate regulatory path with the FDA and found that a 510(k) application would be appropriate. During Phase II of the proposed project, CL will further optimize the OFAM technology and develop multiple prototypes under GMP, demonstrate its sensitivity, reproducibility and repeatability by performing pivotal clinical studies and obtain FDA clearance for marketing the system as an effective uveitis diagnosis tool. By implementing the detailed commercial plan developed during Phase I, with funding from Phase II, ChromoLogic is well positioned to successfully bring this needed technology to the clinic.
The mammalian eye, like the brain, is considered an immunologically privileged organ because it includes multiple mechanisms that stave of inflammation. This is a biological necessity developed to preserve visual acuity. As a result, any inflammation to the eye, known as uveitis affects vision and sometimes, permanently damages it. At any given time, there are approximately 300,000 to 600,000 individuals in the United States that have active uveitis. Approximately 10% of visual handicaps in the western world and up to 15% of all cases of total blindness in the United States is attributed to uveitis. The key to managing active uveitis and preventing deleterious effects resulting form it is timely actionable diagnosis. Current methods of diagnosis for uveitis involve a thorough examination of the eye with a slit lamp microscope and ophthalmoscopy - resulting in a subjective score known as ocular flare. Higher levels of flare in particular have been associated with poor visual outcomes in patients with certain forms of uveitis, such as uveitis associated with juvenile arthritis. Thes tests are both time intensive and largely subjective. The only device that currently is able to provide an objective assessment of the degree of uveitis in the KOWA laser flare meter (FM-600); this is a bench top device that is neither cost effective nor has the sensitivity to diagnose early stages of uveitis. As a result, this 20+ year old technology is not being used for clinical diagnosis today. Given the severity and scale of deleterious outcomes that could result from uveitis and the lack of an objective method to diagnose the condition and monitor any therapies administered, there is an urgent need for a rapid, portable and highly sensitive diagnostic solution.
