Protein Drug Delivery and Formulation Development

Abstract

Several therapeutic agents including low and high molecular weight drugs intended for treating back of the eye disorders are routinely administered as intravitreal injections. Intravitreal injection of Lucentis (R), a therapeutic protein, was approved in 2006 for treating the wet form of age-related macular degeneration. This chapter summarizes the challenges and opportunities in delivering therapeutic proteins to the eye. Specifically, barriers to delivery including permeability barriers, examples of marketed therapeutic agents as well as those under development, formulation approaches for proteins, and novel delivery systems are discussed. Wherever appropriate, other macromolecules such as aptamers that bind specific protein targets are also discussed.