Bromfenac is a potent nonsteroidal anti-inflammatory drug (NSAID) mainly used as a topical ophthalmic solution for reducing postoperative eye inflammation and ocular pain, especially after cataract surgery. It belongs to the acetic acid class of NSAIDs and shows excellent penetration into ocular tissues because of the bromine atom present in its chemical structure. Bromfenac was originally developed for systemic use, and its oral formulation, marketed as Duract, received FDA approval in 1997 for the short-term treatment of acute pain. However, due to severe cases of hepatotoxicity that resulted in liver transplants and deaths, the oral form was withdrawn from the US market in 1998. Later, the drug was successfully redeveloped for ophthalmic use, leading to the approval of Bromfenac eye drops in Japan in 2000 under the brand name Bronuck for postoperative ocular inflammation. In 2005, the FDA approved the 0.09% ophthalmic solution Xibrom in the United States, followed by Bromday (0.09%) in 2010 as a once-daily formulation. Further advancements included the approval of Prolensa (0.07%) in 2013 with a lower concentration for improved dosing convenience, and BromSite (0.075%) in 2016, which used DuraSite technology to enhance ocular retention and therapeutic effectiveness.
