Ocular Flare Meter (OFAM) Development Phase II

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 DESCRIPTION (provided by applicant): 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.