General Information

Acuvail is an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug. It blocks the COX-1 and COX-2 enzymes, which should be blocked in order to inhibit the development of prostaglandins, the primary sources of pain and inflammation following cataract surgery.

Acuvail is specifically indicated for the treatment of pain and inflammation following cataract surgery.

Acuvail is supplied as a solution for topical administration. The recommended initial dose of the drug is one drop applied to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period.

Use with other topical medications
Acuvail solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Clinical Results

FDA Approval
The FDA approval of Acuvail was based on two multi-center, randomized, double-masked, parallel group comparison studies involving more than 500 subjects. The primary efficacy endpoint was defined as complete clearance of anterior chamber inflammation, measured by summed inflammation score (SOIS) and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results demonstrated that at day seven, nearly twice as many subjects receiving Acuvail solution had an SOIS score of zero when compared to subjects treated with placebo (32% versus 17%). In addition, Acuvail resulted in a significantly higher incidence of clearing of anterior chamber inflammation at day 14 versus placebo (53% versus 26%). Acuvail was also significantly superior to placebo in resolving ocular pain post-cataract surgery. On day one post-cataract surgery, the percentage of the Acuvail cohort with pain scores of zero was 72%, compared to 40% for the placebo cohort.

Mechanism of Action

Acuvail is an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug. It is formulated at pH 6.8, enabling deionized drug delivery on the corneal surface and contains carboxymethylcellulose (CMC), a viscous molecule that enables the drug to adhere to the ocular surface and enhances patient comfort. It blocks the COX-1 and COX-2 enzymes, which should be blocked in order to inhibit the development of prostaglandins, the primary sources of pain and inflammation following cataract surgery.

Literature References

Wittpenn JR, Silverstein S, Heier J, Kenyon KR, Hunkeler JD, Earl M; Acular LS for Cystoid Macular Edema (ACME) Study Group A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. American journal of ophthalmology 2008 Oct;146(4):554-560

Duong HV, Westfield KC, Chalkley TH Ketorolac tromethamine LS 0.4% versus nepafenac 0.1% in patients having cataract surgery. Prospective randomized double-masked clinical trial. Journal of cataract and refractive surgery 2007 Nov;33(11):1925-9

Price MO, Price FW Efficacy of topical ketorolac tromethamine 0.4% for control of pain or discomfort associated with cataract surgery. Current medical research and opinion 2004 Dec;20(12):2015-9

Waterbury LD, Flach AJ Efficacy of low concentrations of ketorolac tromethamine in animal models of ocular inflammation. Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics 2004 Aug;20(4):345-52

Solomon KD, Cheetham JK, DeGryse R, Brint SF, Rosenthal A Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery. Ophthalmology 2001 Feb;108(2):331-7