Post cataract surgery pain treatment gets thumbs up

August 5, 2009

ACUVAIL (Allergan), the ketorolac tromethamine ophthalmic solution, which acts as a treatment for inflammation and pain after cataract surgery has been approved by the FDA.

ACUVAIL (Allergan), the ketorolac tromethamine ophthalmic solution, which acts as a treatment for inflammation and pain after cataract surgery has been approved by the FDA.

The drug allows for deionized drug delivery on the corneal surface. The efficacy of ACUVAIL was assessed in two multi-centre, randomized, double-masked, parallel group comparison studies involving more than 500 patients receiving either ACUVAIL(TM) or a placebo. According to Allergan, in the clinical studies, the efficacy of the drug 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 of these studies demonstrated that at day seven, nearly twice as many patients receiving ACUVAIL solution had an SOIS score of zero when compared to patients treated with placebos (32 percent versus 17 percent). In addition, patients were shown to have a significantly higher incidence of clearing of anterior chamber inflammation at day 14 versus patients receiving placebos (53 percent versus 26 percent). ACUVAIL was also shown to be significantly superior to vehicle in resolving ocular pain post-cataract surgery. On day one post-cataract surgery, the percentage of ACUVAIL patients with pain scores of zero was 72 percent, compared to 40 percent for patients in the vehicle group.