Onset of action is 2 to 4 hours after application, the maximal effect is reached after 12 hours, and ocular pressure remains lowered for at least 24 hours.Tafluprost acid is inactivated by beta oxidation to 1,2-dinortafluprost acid, 1,2,3,4-tetranortafluprost acid, and its lactone, which are subsequently glucuronidated or hydroxylated. The cytochrome P450 liver enzymes play no role in the metabolism.An analogous pathway (at least up to the tetranor-metabolites) has been found for latanoprost and travoprost. == References ==
The efficacy results presented were confirmed in a study published in 2007.Nevanac was approved by the FDA on August 19, 2005, with application number 021–862. Ilevro
An NDA for Ilevro was filed on December 15, 2011. In a one-month study, no new toxicities arose in the new formulation of nepafenac. Safety and efficacy information was derived from the previous Nevanac application. In June 2010, a confirmatory study began (Study C09055) consisting of over 2000 patients from 49 US sites and 37 European sites. A second phase 3 trial (Study C11003) was conducted in a population of 1,342 patients at 37 sites across the United States which failed to demonstrate superiority over Nevanac in an altered dosing regimen.Ilevro was approved by the FDA on October 16, 2012, with application number 203–491. Commercialization
Both Nevanac and Ilevro are manufactured and sold by Alcon, Inc. Alcon is currently a division of Novartis International AG, which is primarily based out of Switzerland. Alcon, Inc. also holds locations in both Switzerland and the United States. The company has gone through several name changes, from Alcon Laboratories, Inc. to Alcon Universal, Ltd., to Alcon, Inc.Nevanac entered the market in 2005 as a product of Alcon, at the time a subsidiary of Nestlé. On April 6, 2008, Novartis agreed to purchase approximately 74 million shares of Alcon from Nestlé at $143.18 per share. On January 4, 2010, Novartis agreed to purchase all remaining shares of Alcon from Nestlé, totalling 156 million shares or 77% of the shares in the company.