SUSTAINED RELEASE CYCLOSPORIN FOR TREATMENT OF UVEITIS

描述(改编自《调查者摘要》)：宽泛、冗长- 本研究的短期目标是减少或消除因以下原因造成的失明 葡萄膜炎。一种有希望的眼内缓释装置 环孢菌素A(CsA)正在学术界进行研究。这个设备是 与Vitrasert类似，6-8个月缓释更昔洛韦 设备，由相同的研究人员开发，需要5-6 mm的分析器 用于插入的平面切口术。作为SBIR EY-43-11316的一部分，他们拥有 改进了Vitrasert，使其可以插入3-4 mm 切开。本提案中描述的这项工作的目的是 进行前期工作以适应这项Vitrasert 2技术，以便 准备5年CSA装置，可通过小切口植入。这个 因此，这项建议的具体目标是：1.开发和生产 大小剂量“Vitrasert 2”；2.验证灭菌程序 对于这些；设备。3.体内释放度的测定。 在成功完成这项第一阶段研究之后，将有大型 这些系统的比例尺编制，提交调查性新 药品豁免和启动临床试验。这项工作将形成 这是我们第二阶段SBIR提案的基础。 控制输送系统(CDS)在药物的各个方面都有经验 审批流程。他们的第一个产品，Vitrasert，被授权给 奇龙视界。销售这款设备的版税使他们能够 将内部CDS资金用于此工作的第三阶段。 在美国，大约有3万人因为 葡萄膜炎。这项工作的成功完成将产生一种产品 这将在未来减少这一数字。这个产品将会有 孤儿药物状况和一条将有助于实现这一目标的“快车道”监管途径 以确保其商业可行性。

DESCRIPTION (Adapted from the Investigator's Abstract): The broad, long- term goal of this research is to reduce or eliminate the blindness due to uveitis. A promising device for the sustained intraocular release of cyclosporine A (CsA) is being investigated in academia. This device is similar to the Vitrasert, a 6-8 month sustained-release ganciclovir device, developed by the same investigators that requires a 5-6 mm pars plana incision for insertion. As part of SBIR EY-43-11316, they have improved the Vitrasert so that it can be inserted through a 3-4 mm incision. The purpose of this work described in this proposal is to perform preliminary work to adapt this Vitrasert 2 technology so as to prepare 5 year CsA devices implantable through small incisions. The specific aims of this proposal therefore are to: 1. Develop and produce high and low dose "Vitrasert 2"; 2. Validate the sterilization procedures for these; devices. 3. Test release rates of the devices in vivo. Successful completion of this Phase 1 study will be followed by large scale preparation of these systems, submission of an Investigational New Drug Exemption and initiation of clinical trials. This work will form the basis of our Phase 2 SBIR proposal. Control delivery Systems (CDS) has experience in all aspects of the drug approval process. Their first product, the Vitrasert, was licensed to Chiron Vision. Royalties from the sale of this device allow them to commit internal CDS funds to Phase 3 of this work. Approximately 30,000 people in the United States are blind because of uveitis. The successful completion of this work will result in a product which will reduce that number in the future. This product will have orphan drug status and a "fast track" regulatory pathway which will help to ensure its commercial viability.