Nepafenac in the Treatment of Ocular Inflammation Following Cataract Surgery (Pseudophakic Macular Oedema) – an Update

Abstract

Cataract surgery is a hugely important means of preventing poor-quality vision or vision loss, especially in the elderly and people with diabetes. Pseudophakic macular oedema (PMO) is a comparatively infrequent complication occurring in 0.2–2.35% of patients, but the increasing scale of cataract surgeries worldwide makes it a widespread and significant problem. PMO can affect vision and, if untreated, can damage the retina and, less commonly, cause pain. Effective and convenient treatment for PMO, therefore, is an important issue. The pathophysiology of PMO is not fully understood, but may result from multiple factors including traction, irritation and disturbance of the blood-retinal barrier, leading to secretion of inflammatory factors which affect the posterior segment. Among the non-steroidal anti-inflammatory drugs used in the management of PMO is nepafenac (NPF). NPF is a unique prodrug and use of the 0.1% formulation given three times daily is supported by several key phase II and III clinical trials, in which prophylactic use resulted in lower incidence of PMO, better visual outcomes and lower central subfield macular thickness than vehicle alone. Several studies have also shown that 0.1% NPF provided superior efficacy compared with bromfenac, fluorometholone or ketorolac in the treatment of PMO. More recently, a 0.3% NPF formulation has been developed to provide more convenient once daily dosing. A phase III trial (n=819) showed that 0.3% NPF was non-inferior to 0.1% NPF in terms of inflammation and proportion or patients who were pain-free with similar safety profiles for both doses. Other evidence from phase II and III vehicle-controlled, non-comparative trials also indicate the equivalence of frequent 0.1% NPF and the less frequent 0.3% NPF dosing. Greater use of the more convenient 0.3% NPF formulation may help improve patient adherence and consequently provide better outcomes in PMO.