Acuvail (ketorolac tromethamine)

Company
Allergan

Approval Status
Approved July 2009

Treatment for
pain and inflammation following cataract surgery

Areas
Eye Health / Ophthalmology

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.

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.

Adverse events associated with the use of Acuvail may include, but are not limited to, the following:

  • intraocular pressure
  • conjunctival hyperemia
  • hemorrhage
  • corneal edema
  • ocular pain
  • headache
  • tearing
  • vision blurred

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.

For additional information regarding Acuvail or pain and inflammation following cataract surgery, please visit the Acuvail web page.

Acuvail Drug Information

The Acuvail drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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