Diclofenac sodium 0.1% ophthalmic solution has a long, well-proven track record as a potent, efficacious, topical, ocular anti-inflammatory agent, especially in the control of miosis during surgery, postsurgical inflammation of the anterior segment, cystoid macular edema and inflammation owing to noninfectious conjunctivitis such as allergic conjunctivitis. Owing to its analgesic properties, it is also widely used for short-duration treatment in pain associated with photorefractive keratectomy and corneal erosion. Therefore, it has been approved by health authorities for a wide range of indications, depending on each country. It has been shown to be at least as effective as other nonsteroidal anti-inflammatory drugs and corticosteroids. Diclofenac is a well-tolerated product and the few serious corneal adverse events that do occur could be avoided by good prescriptive practice and careful follow-up of patients at-risk. This review summarizes the available data on pharmacokinetics and pharmacodynamics, as well as the efficacy, safety and regulatory aspects related to diclofenac.