Acuvail™ From Allergan Receives FDA Approval for Post-Cataract Surgery Treatment
July 31, 2009
Allergan, Inc. has announced that the company has received FDA approval for ACUVAIL™ (ketorolac tromethamine ophthalmic solution) 0.45% which is an advanced, preservative-free formulation of ketorolac, a NSAID indicated for the treatment of pain and inflammation following cataract surgery.
ACUVAIL™ contains carboxymethylcellulose (CMC), a viscous molecule also found in Allergan’s REFRESH(R) Brand Tears that enables the drug to adhere to the ocular surface and enhances patient comfort. This formulation is dosed twice a day.
The efficacy of ACUVAIL™ was assessed in two multi-center, randomized, double-masked, parallel group comparison studies involving more than 500 patients receiving either ACUVAIL™ or vehicle. In the clinical studies, efficacy 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 implantation. Results of these studies showed that at day seven, 32% of patients receiving ACUVAIL™ solution had an SOIS score of zero when compared to 17% of patients treated with vehicle.
Acuvail™ is expected to be available for physicians and patients in September 2009.
Read the release.
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