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| |  FDA Approves Preservative-Free Ketorolac Formulation Ophthalmic Solution for Treatment of Pain, Inflammation Following Cataract Surgery IRVINE, Calif -- July 23, 2009 -- The US Food and Drug Administration (FDA) has approved ketorolac tromethamine ophthalmic solution 0.45% (ACUVAIL), an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug indicated for the treatment of pain and inflammation following cataract surgery. The enhanced formulation offers optimised tolerability and a twice-daily dosing regimen, it was announced today by Allergan, Inc. Ketorolac tromethamine ophthalmic solution is formulated at pH 6.8, enabling deionised drug delivery on the corneal surface. Ketorolac tromethamine ophthalmic solution contains carboxymethylcellulose, a viscous molecule also found in over-the-counter artificial tears that enables the drug to adhere to the ocular surface and enhances patient comfort. With ketorolac tromethamine ophthalmic solution, patients benefit from the drug's comprehensive inhibition of the cyclooxygenase (COX)-1 and COX-2 enzymes. Studies show that those enzymes should be blocked in order to inhibit the development of prostaglandins, which are considered to be the primary sources of pain and inflammation following cataract surgery. The efficacy of ketorolac tromethamine ophthalmic solution was assessed in 2 multicentre, randomised, double-masked, parallel-group comparison studies involving more than 500 patients receiving either ketorolac tromethamine ophthalmic solution or vehicle. In the clinical studies, the efficacy of ketorolac tromethamine ophthalmic solution was defined as complete clearance of anterior chamber inflammation measured by summed ocular inflammation score (SOIS) and ocular pain relief following cataract extraction with posterior chamber intraocular lens implantation. Results of these studies demonstrated that at day 7, nearly twice as many patients receiving ketorolac tromethamine ophthalmic solution had an SOIS score of zero when compared with patients treated with vehicle (32% vs 17%). In addition, patients were shown to have a significantly higher incidence of clearing of anterior chamber inflammation at day 14 versus patients receiving vehicle (53% vs 26%). Ketorolac tromethamine ophthalmic solution was also shown to be significantly superior to vehicle in resolving ocular pain post-cataract surgery. On day 1 post cataract surgery, 72% of patients treated with the ketorolac tromethamine ophthalmic solution demonstrated pain scores of zero compared with 40% for patients in the vehicle group. Ketorolac tromethamine ophthalmic solution 0.45% is expected to be available to physicians and patients in the United States in September 2009. SOURCE: Allergan, Inc.
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