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.
