Ketorolac 0.45% ophthalmic solution is a topical NSAID indicated in the US for the treatment of ocular pain and inflammation following cataract surgery. In animal studies, the ocular relative bioavailability of single-dose topical ketorolac 0.45% ophthalmic solution was 2- to 3-fold higher than that of ketorolac 0.4% ophthalmic solution. In two identically designed, randomized, double-masked, multicentre trials in adult patients undergoing cataract extraction, the proportions of patients with a summed ocular inflammation score of zero for anterior chamber cell count plus anterior chamber flare on day 14 after surgery were significantly greater in those treated with topical ketorolac 0.45% ophthalmic solution than in those treated with vehicle placebo. Compared with placebo, topical ketorolac 0.45% ophthalmic solution significantly increased the proportion of patients who were pain-free on the day after surgery in both trials. Ketorolac 0.45% ophthalmic solution was generally well tolerated in clinical trials with lower overall incidences of treatment-emergent and treatment-related adverse events than placebo, and with no single treatment-related adverse event having a higher incidence than with placebo.