SUSTAINED RELEASE CYCLOSPORIN FOR TREATMENT OF UVEITIS

描述（改编自研究者摘要）：广泛的，长期的- 本研究的长期目标是减少或消除因 葡萄膜炎 一种有前途的眼内缓释装置， 环孢菌素A（CsA）是目前学术界研究的热点。 这个设备是 类似于Vitrasert，6-8个月的缓释更昔洛韦 由同一研究者开发的器械，需要5-6 mm的部分 平面切口插入。 作为SBIR EY-43-11316的一部分， 改进了Vitrasert，使其可以通过3-4 mm 切口 本建议书所述工作的目的是 进行初步工作，以适应Vitrasert 2技术， 准备通过小切口植入的5年CsA器械。 的 因此，这项建议的具体目标是：1。 开发和生产 高剂量和低剂量“Vitrasert 2”; 2. 灭菌程序 这些;装置。 3. 测试器械在体内的释放速率。 成功完成这项1期研究后，将进行大规模的 这些系统的规模准备，提交研究性新 药物豁免和启动临床试验。 这项工作将形成 我们的第二阶段SBIR提案的基础。 控释系统（CDS）在药物的各个方面都有经验 审批过程。 他们的第一个产品，Vitrasert，被授权 喀戎视觉 该设备的销售所产生的特许权使用费使他们能够 将内部CDS资金投入到这项工作的第三阶段。 在美国，大约有30，000人因 葡萄膜炎 这项工作的成功完成将产生一个产品 这将在未来减少这一数字。 该产品将具有 孤儿药地位和“快速通道”监管途径，这将有助于 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.