Novel NSAID prodrug demonstrates safety, efficacy in management of cataract

April 18, 2005

Washington, DC &#8212 Results of a prospective, randomized, double-masked, vehicle-controlled clinical trial demonstrate the efficacy and safety of nepafenac 0.1% ophthalmic suspension for reducing anterior segment inflammation and minimizing pain after cataract surgery, said Stephen S. Lane, MD.

April 19 - Washington, DC - Results of a prospective, randomized, double-masked, vehicle-controlled clinical trial demonstrate the efficacy and safety of nepafenac 0.1% ophthalmic suspension for reducing anterior segment inflammation and minimizing pain after cataract surgery, said Stephen S. Lane, MD.

He presented the findings from a multicenter study that involved the participation of 21 investigators and included 476 evaluable subjects. Patients were randomized 1:1 to treatment with vehicle or nepafenac administered 3 times a day beginning 1 day preoperatively and continued until day 14 after surgery. Assessments were performed at days 1, 3, 7, and 14.

Percentage of cures, defined as the absence of cells and flare, was evaluated as the primary efficacy outcome and showed statistically significant differences favoring nepafenac over vehicle at all follow-up visits. Secondary efficacy analyses showed nefapanac was also associated with statistically significant benefits for reducing the rate of clinically significant inflammation, increasing the proportion of patients who were pain-free, and reducing treatment failure rates. There were no treatment-related adverse drug events in either study group.

"Nepafenac is a prodrug that has the potential to maximize efficacy and minimize toxicity. It rapidly penetrates the cornea and then is converted by intraocular hydrolases to amfenac, a potent nonsteroidal anti-inflammatory drug that has activity in the choroid, retina, and ciliary body. We look forward to other clinical trials to evaluate the potential benefits of this very novel agent," Dr. Lane said.

Nepafenac is being developed by Alcon. Dr. Lane is a consultant to that company.