The broad long term goal of this project is to develop an in vivo - in vitro correlation method (IVIVC) that can be applied to the assessments of intravitreal sustained release implants. Understanding IVIVC will greatly assist the FDA and the pharmaceutical industry in development and approval of generic and bioequivalent products. A secondary goal of this project is the development of a bioequivalent sustained release ganciclovir intravitreal implant to fill an unmet orphan medical need. For commercial reasons the Vitrasert has been removed from the market and is unlikely to be otherwise replaced. We propose a development strategy to make this therapeutic modality available to the small number of patients for whom it is the treatment of choice. The Vitrasert(R) was invented in the academic laboratory of the principal investigator of this proposal in 1989. In 1995 in collaboration with Chiron it was approved under NDA 020569. We believe that we are uniquely qualified to carry out this project.
To assist the FDA and industry in the development of bioequivalent intravitreal sustained release delivery devices we propose the development of an in vivo-in vitro correlation for the ganciclovir releasing implant, Vitrasert(R). A secondary benefit of this work is the provision of bioequivalent ganciclovir to meet a serious unmet orphan medical need.
