Ocular Flare Meter (OFAM) Development Phase II

 描述(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，但临床上还没有一种被临床接受的方法来对眼睛闪光进行定量评估，从而导致对葡萄膜炎的快速、非侵入性诊断。目前诊断葡萄膜炎的方法包括用裂隙灯显微镜和眼底镜彻底检查眼睛。在某些形式的葡萄膜炎患者中，较高水平的闪光尤其与视力不良有关，例如与幼年性关节炎相关的葡萄膜炎(Holland&Stiehm 2003)(Rosenberg等人)。2004年)。这些测试既是时间密集型的，又是很大程度上主观的(Kempen等人。2008年)。目前FDA批准的唯一能够对葡萄膜炎程度进行客观评估的设备是KOVA激光闪光仪(FM-600)；这是一种台式设备，不具备诊断早期干预至关重要的轻度葡萄膜炎的临床敏感性(Ladas E.T al.2005)。再者，它不适合S性价比高的临床广泛使用。为了满足这一重大的健康需求，ChromoLogic LLC(CL)在第一阶段提出、开发并验证了便携式眼部闪光仪(OFAM)，这是一个非侵入性仪器平台，在不到1分钟的时间内就能诊断疾病和辐射导致的血眼屏障破坏。彻底的体外和中试动物试验(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，敏感性远远超过商业台式KOVA产品，并与目前使用的主观评分机制有很好的相关性。同样在第一阶段，团队提交了适当的监管路径，并与FDA进行了谈判，发现510(K)申请将是合适的。在拟议项目的第二阶段，CL将进一步优化OFAM技术，并在GMP下开发多个原型，通过进行关键的临床研究来证明其敏感性、重复性和可重复性，并获得FDA批准将该系统作为有效的葡萄膜炎诊断工具进行营销。通过实施在第一阶段制定的详细商业计划，在第二阶段的资助下，ChromoLogic处于有利地位，能够成功地将这项所需的技术带到临床上。

 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.