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Drug development issues in pharmacological treatments for dry eye.

Several pharmacological approaches for the treatment of dry eye are currently being developed by pharmaceutical firms, including attenuation of the immune response, hormonal modulation, and enhanced mucin release. Since an overview of the procedural aspects of ophthalmic drug development, i.e. Investigational New Drug Exemption (IND), Clinical Phases 1 through 3, New Drug Application (NDA), etc.. 1-2, as well as the financial implications of this development for glaucoma drugs3 were presented previously, this review focuses on investment issues in the development of pharmacological treatments for dry eye. Development cost and timing, and the market potential of a putative pharmacological treatment for dry eye, were evaluated.