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Published online: 16 July 2015
© Springer International Publishing Switzerland 2015
Abstract The nonsteroidal anti-inflammatory drug bromfenac has recently been reformulated with a lower pH to facilitate a reduction in the concentration of bromfenac (to 0.07 %) while ensuring an ocular bioavailability similar to that of the 0.09 % formulation. Bromfenac ophthalmic solution 0.07 % (hereafter referred to as bromfenac 0.07 %) [Prolensa®] is a once-daily topical ophthalmic solution available in the USA and Canada for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In an integrated analysis of two multicentre, phase III studies, bromfenac 0.07 % was significantly more effective than placebo in reducing ocular inflammation and pain. In these studies, bromfenac 0.07 % was well tolerated, with significantly lower incidences of adverse events, and adverse events affecting the study eye than with placebo. The most common adverse events in the study eye (eye pain, anterior chamber inflammation, foreign body sensation, photophobia, conjunctival hyperaemia and corneal oedema) occurred in numerically fewer bromfenac 0.07 % than placebo recipients. Thus, current evidence suggests once-daily bromfenac 0.07 % extends the treatment options currently available for the management of postoperative inflammation and pain following cataract surgery.
1 Introduction
The ocular surface trauma associated with cataract surgery can induce an inflammatory response [1, 2]. Such a response can result in patient discomfort and delayed recovery, with persistent inflammation leading to compromised visual outcomes and cystoid macular oedema (CME) [2]. Postoperative inflammation and pain following cataract surgery are routinely managed with topical ophthalmic corticosteroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) [2, 3]. In order to be clinically effective, topical ophthalmic NSAIDs must be capable of penetrating the affected tissues and remaining within those tissues at sufficient levels throughout the dosing interval [3].
Topical ophthalmic agents are often reformulated to improve their bioavailability and/or reduce the frequency of dosing [4]. Strategies for accomplishing this include increasing the concentration of the active ingredient and modifying the vehicle without increasing the concentration [4]. For instance, reducing the pH of weakly acidic drug formulations such as NSAIDs increases the unionized fraction of the drug, thereby enhancing permeation [5]. The NSAID bromfenac has previously been formulated as a 0.09 % ophthalmic solution (hereafter referred...