The FDA has approved Acuvail (ketorolac tromethamine ophthalmic solution, from Allergan), a non-steroidal anti-inflammatory drug (NSAID), indicated for the treatment of pain and inflammation following cataract surgery. This approval was based on results from two multicenter, randomized, double-masked, parallel group comparison studies involving more than 500 patients receiving either Acuvail or vehicle. The efficacy of Acuvail 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. Of the patients treated with Acuvail, 32% had an SOIS score of zero at Day 7 versus 17% of vehicle-treated patients. Additionally, patients who received Acuvail demonstrated a significantly higher incidence of clearing of anterior chamber inflammation at Day 14 compared to patients receiving vehicle (53% versus 26%). Acuvail was also significantly superior to vehicle in resolving ocular pain post-cataract surgery. On Day 1 post-cataract surgery, 72% of Acuvail treated patients had pain scores of zero versus 40% of patients treated vehicle.

Acuvail is formulated at pH 6.8 to enable deionized drug delivery on the corneal surface, is preservative-free, and contains carboxymethylcellulose, which enables the drug to adhere to the ocular surface. Acuvail is expected to be available in September 2009 in a 0.45% strength.  

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