Regulatory Considerations in Product Development for Back of the Eye

Abstract

This chapter strives to provide an understanding of the overall drug product approval process and highlights the key points that a sponsor needs to focus on in order to successfully develop and market a posterior ocular segment drug. Furthermore, the chapter reviews the product summary basis of approvals for two recently approved and marketed products namely Ozurdex™, a dexamethasone containing intraocular drug delivery system for the treatment of macular edema following branch or central retinal vein occlusion (BRVO or CRVO) and Lucentis™, a recombinant, humanized monoclonal IgG1 antibody antigen-binding fragment (Fab) indicated for neovascular (wet) age-related macular degeneration (ARMD). The importance of scientific dialogue between the sponsor and the corresponding health agency is emphasized and encouraged.