Allergan Receives FDA Approval For Acuvail Ophthalmic Solution

FDA has approved Allergan’s ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45%, a preservative-free formulation of ketorolac. Its a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation, following cataract surgery.

Reportedly, Acuvail is formulated at pH 6.8, enabling deionized drug delivery on the corneal surface.

The company claims that in the clinical studies, 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.

Scott Whitcup, executive vice president of R&D and chief scientific officer of Allergan, said: We are pleased to provide physicians and their patients with an advanced and effective NSAID option for the treatment of pain and inflammation following cataract surgery. With its preservative-free formulation, optimized tolerability and twice-daily dosing convenience, we anticipate that ACUVAIL will be a valuable addition to the overall management of cataract surgery patients.