Sustained Release Intravitreal Corticosteroid Injections

描述（由申请人提供）：本研究的长期目标是通过开发用于抗炎药物的持续释放玻璃体内注射制剂来减少或消除由于眼后部疾病导致的失明。在以前的工作中，部分通过SBIR第1和第2阶段的资金支持，主要研究者开发了Vitrasert（r）缓释植入物，FDA于1995年批准用于治疗CMV视网膜炎，Retisert（tm）缓释植入物目前正在FDA的NDA审查中。本申请的具体目的是：1、配制醋酸氟轻松的缓释混悬液; 2、测试这些制剂在缓冲液中的体外释放特性; 3、测试这些制剂在兔玻璃体内注射后的体内药代动力学和安全性。研究团队是聚合物化学、药代动力学和药物开发方面的专家。我们在药物开发过程的各个方面都有经验，从概念到批准和营销。这些具体目标的成功完成将构成一个易于识别的里程碑，这将使我们能够继续进行本申请的第2阶段，我们将在后葡萄膜炎动物模型中测试器械的有效性，并完成必要的实验室工作，以申请FDA的研究性新药豁免。

DESCRIPTION (provided by applicant): The long term goal of this research is to reduce or eliminate blindness due to diseases of the back of the eye by developing sustained release intravitreal injectable formulations for anti-inflammatory drugs. In previous work, supported in part through SBIR Phase 1 and 2 funding, the Principal Investigator has developed the Vitrasert(r) sustained release implant approved by the FDA for the treatment of CMV retinitis in 1995, and the Retisert(tm) sustained release implant currently under NDA review by the FDA. The specific aims of this application are to: 1, formulate sustained release suspensions of fluocinolone acetonide; 2, test the in vitro release characteristics of these formulations into buffer; and 3, test the in vivo pharmacokinetics and the safety of the formulations after intravitreal injection in the rabbit. The team of investigators is expert in polymer chemistry, pharmacokinetics and drug development. We have experience in all aspects of the drug development process, from concept to approval and marketing. The successful completion of these specific aims will constitute a readily identifiable milestone which will permit us to continue with Phase 2 of this application where we will test the efficacy of the devices in animal models of posterior uveitis and complete the requisite laboratory work to apply for an Investigational New Drug Exemption from the FDA.