Ketorolac tromethamine 0.45% approved by FDA

August 15, 2009

Ketorolac tromethamine 0.45% (Acuvail, Allergan) is a preservative-free ophthalmic NSAID recently approved for twice-daily use in treating pain and inflammation after cataract surgery. Its novel formulation is designed to promote drug delivery and tolerability.

Key Points

Rockville Centre, NY-The FDA has approved a new ophthalmic formulation of ketorolac tromethamine, ketorolac tromethamine 0.45% (Acuvail, Allergan).

Patients administer one drop of the solution to the affected eye twice daily beginning the day before cataract surgery, then continue using the solution on the day of surgery and through the first 2 weeks of the postoperative period.

"In the modern era of cataract surgery, ophthalmologists need to provide patients optimal comfort and safety in addition to performing an effective procedure," Dr. Donnenfeld said. "This new formulation of ketorolac works well toward achieving that goal. It is the first and only preservative-free, twice-daily ophthalmic [nonsteroidal anti-inflammatory drug (NSAID)] that in clinical evaluation demonstrated complete elimination of inflammation in a majority of patients undergoing cataract surgery."

He was an investigator in one of the pivotal trials that led to the FDA approval of ketorolac 0.45% and is the lead author of a paper reporting on the pooled data that will be presented at the annual meeting of the American Academy of Ophthalmology in October.

The efficacy and safety of ketorolac 0.45% were investigated in two identically designed, multicenter, double-masked prospective trials enrolling more than 500 patients who were randomly assigned 2:1 to twice-daily treatment with ketorolac 0.45% or vehicle control for 16 days. Patients were instructed to begin using their assigned study agent on the day before surgery.

Resolution of inflammation at day 14 after surgery was the primary efficacy endpoint. Evaluation showed the statistically significant superior efficacy of ketorolac 0.45% versus vehicle: 53% of patients using ketorolac and 26% of controls had a summed ocular inflammation score of 0 (p < 0.001).

"The efficacy of ketorolac was actually documented much earlier," Dr. Donnenfeld said. "By postop day seven, 32% of ketorolac-treated patients had already achieved complete elimination of inflammation, compared with only 17% of controls. The benefit of ketorolac was statistically significant and clinically impressive."

Pain relief was assessed as a secondary outcome measure, and the data showed that ketorolac also was highly effective in controlling pain. On the first day after surgery, 72% of patients using ketorolac were pain-free compared with 40% of patients in the control group (p < 0.001).