The broad long term goal of this research is to reduce or eliminate blindness due to uveitis. In phase I of this SBIR we developed 3 year intraocular cyclosporine devices. We prepared high and low dose devices, validated sterilization procedures, and began release rate testing in vivo. Preclinical efficacy and toxicity data has enabled a Phase I/II clinical safety study to be initiated at the National Eye Institute and Duke University. Phase II/III efficacy studies will follow the successful completion of this work.
The specific aims of this Phase II SBIR proposal therefore are to: 1. complete the pharmacokinetic work begun in phase 1; 2. adapt the experimental manufacturing process for commercialization; and 3. design the Phase III clinical trials, including selection and inspection of clinical centers. Control Delivery Systems (CDS) has experience in all aspects of the drug approval process. Our first product the VitrasertTM was licensed to Chiron Vision. Royalties from the sale of this device allow us to commit internal funds to guarantee completion of Phase 3 of this work. We are currently negotiating the license for this product with a major ophthalmic company in order to guarantee the commercialization of the implant on the successful completion of the trials.
Approximately 100,000 people in the USA are blind in one or both eyes because of uveitis. This product will have orphan drug status and a """"""""fast track"""""""" regulatory pathway that will help us to ensure its commercial viability.
