General Information

Acular (ketorolac tromethamine) ophthalmic solution is a nonsteroidal, anti-inflammatory.

Acular (ketorolac tromethamine) ophthalmic solution 0.5% is indicated for the prophylaxis and the relief of postoperative ocular inflammation in patients undergoing cataract extraction with or without implantation of an intraocular lens.

Acular LS (ketorolac tromethamine) ophthalmic solution 0.4% is indicated for the reduction of ocular pain and ocular symptoms of foreign body sensation, burning/stinging, tearing, and photophobia following refractive surgery.

Acular is supplied as a solution for administration directly into the eye. The recommended dose of Acular is one to two drops (0.25 mg ‐ 0.5 mg) every six to eight hours beginning 24 hours before surgery and continuing for three to four weeks for prophylaxis and relief of postoperative ocular inflammation. The recommended dose of Acular LS is one drop four times a day for up to four days in the affected eye.

Clinical Trials

In two double‐masked, multi‐centered, parallel‐group studies, 313 patients who had undergone photorefractive keratectomy received Acular LS (ketorolac tromethamine) ophthalmic solution 0.4% or its vehicle four times daily for up to 4 days. Significant differences favored Acular LS for the treatment of ocular pain and the ocular symptoms of foreign body sensation, burning/stinging, tearing, and photophobia.

Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis. Two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle. Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

Mechanism of Action

Acular (ketorolac tromethamine ophthalmic solution) is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.