This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development.

  • An understanding of ophthalmology and the scientific requirements for topical ophthalmic drugs and devices
  • Development and manufacturing of ophthalmic drug products.
  • Knowledge of US ophthalmology regulatory requirements
  • Overall clinical drug development issues
  • A thorough knowledge of ophthalmology clinical trial design and conducting clinical trials that meet regulatory guidelines

Regulatory Focus 14:47-52, 2009.