This excerpt taken from the ACL 6-K filed Aug 25, 2005.
Clinical Study Results
The approval is based on results of two multi-center, placebo-controlled studies involving over 680 patients. In these clinical trials, NEVANAC suspension was dosed three times per day, beginning one day prior to cataract surgery and continuing on the day of surgery and for 14 days postoperatively. Patients were evaluated at baseline and at one, three, seven and 14 days after surgery. Patients treated with NEVANAC suspension were found to have significantly less ocular pain and inflammation in the early postoperative period through the end of treatment.
In these studies, more than 80 percent of patients treated with NEVANAC suspension were pain free the day after surgery, compared to less than 50 percent in the placebo group. Following two weeks of treatment with NEVANAC suspension, approximately 95 percent of patients were pain free, compared to 45 percent of patients in the placebo group. Additionally, 91 percent of patients treated with NEVANACTM suspension had no clinically significant inflammation at Day 14, compared to approximately 47 percent of patients in the placebo group. In the studies, NEVANAC suspension was shown to be safe and well tolerated with no unexpected adverse events reported.
In controlled clinical studies, the most frequently reported ocular adverse events following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately five to 10 percent of patients. These events were similar to those reported with placebo and may be the consequence of the cataract surgery procedure.