FDA approves preservative-free ketorolac formulation for post-cataract pain, inflammation

IRVINE, Calif. — The U. S. Food and Drug Administration has approved an advanced, preservative-free formulation of ketorolac for treating pain and inflammation after cataract surgery, according to a press release from Allergan, the developer of the drug.

The drug, called Acuvail (ketorolac tromethamine ophthalmic solution 0.45%), contains carboxymethylcellulose, which enables the drug to adhere to the ocular surface to enhance patient comfort, and is formulated at pH 6.8, enabling for deionized drug delivery, the release said.

The FDA approval follows positive results from two randomized, double-masked, parallel group, multicenter clinical trials that evaluated inflammation and pain relief for more than 500 patients who received either Acuvail or placebo after cataract extraction with posterior chamber IOL implantation.

At 7-days postop, nearly twice as many patients receiving Acuvail had achieved a summed ocular inflammation score of zero compared with patients treated with placebo. In addition, patients who received the drug had a significantly higher incidence of clearing of anterior chamber inflammation at day 14 compared with patients who received placebo.

Acuvail also demonstrated statistically significant superiority to placebo for resolving ocular pain after cataract surgery; at 1-day postop, 72% of patients who received the drug had pain scores of zero, compared with 40% of patients who received placebo.

Allergan plans to make the drug available in the U.S. in September.