Alcon, Inc, the $4-billion eye care company, presented Phase III clinical data on its investigational new drug, Nevanac (nepafenac 0.1% ophthalmic suspension) at the American Society of Cataract and Refractive Surgeons in Washington, DC.

US FDA has accepted Alcon's new drug application (NDA) for Nevanac suspension for the treatment of pain and inflammation associated with cataract surgery and has granted the application a priority review, the company announced here.

Both clinical studies demonstrated that Nevanac suspension dosed three times per day, in the absence of steroid therapy, was effective in controlling pain and post-operative inflammation associated with cataract surgery. More than 80 percent of patients treated with Nevanac suspension were pain free on day one, compared to only 40 to 50 per cent in the placebo group. By day 14, approximately 95 per cent of patients were pain free when treated with the drug, compared to 45 to 60 per cent of patients in the placebo group. Results for inflammation control were similarly positive, as greater than 85 per cent of patients treated with Nevanac suspension had no clinically significant inflammation at day 14, compared to approximately 49 per cent of patients in the placebo group.

Nevanac suspension is a novel pro-drug that rapidly penetrates ocular tissues and is converted intraocularly into amfenac, a potent non-steroidal anti-inflammatory drug (NSAID).