Ocular Flare Meter (OFAM) Development Phase II

 描述（由申请人提供）：尽管美国约有300，000至600，000人患有活动性葡萄膜炎，但目前尚无临床上可接受的方法用于定量评估眼闪辉，从而快速、无创地诊断葡萄膜炎。目前诊断葡萄膜炎的方法包括用裂隙灯显微镜和检眼镜对眼睛进行彻底检查。尤其是较高水平的闪辉与患有某些形式的葡萄膜炎的患者的不良视力结果相关，例如与青少年关节炎相关的葡萄膜炎（Holland & Stiehm 2003）（Rosenberg等人2004）。这些测试既耗时又主观（Kempen等人，2008年）。目前唯一能够客观评估葡萄膜炎程度的FDA批准器械是KOWA激光闪光仪（FM-600）;这是一种台式器械，不具有诊断轻度葡萄膜炎的临床灵敏度，其中早期干预至关重要（Ladas等人，2005）。此外，它不适合成本有效的广泛临床使用。为了克服这一主要的健康需求，ChromoLogic LLC（CL）在第一阶段提出，开发和验证了便携式眼耀斑仪（OFAM）-一种非侵入性仪器平台，在不到1分钟的时间内诊断疾病和辐射引起的血眼屏障破坏。全面的体外和试点动物（NHP）和临床试验（N=100）已经证明了该技术的有效性。结果还表明，灵敏度远远超过市售的台式KOWA产品和良好的相关性，目前使用的主观评分机制。同样在第一阶段，该团队提交并与FDA协商了适当的监管途径，并发现510（k）申请是合适的。在拟议项目的第二阶段，CL将进一步优化OFAM技术，并根据GMP开发多个原型，通过进行关键临床研究证明其灵敏度，重现性和可重复性，并获得FDA批准将该系统作为有效的葡萄膜炎诊断工具推向市场。通过实施第一阶段制定的详细商业计划，并利用第二阶段的资金，ChromoLogic能够成功地将这一所需的技术应用于临床。

 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.