FDA accepts new drug application for ophthalmic NSAID

September 6, 2005

The FDA has approved Alcon Laboratories’ new drug application for nepafenac ophthalmic suspension 0.1% (Nevanac) for the treatment of pain and inflammation associated with cataract surgery. The company anticipates the ophthalmic nonsteroidal anti-inflammatory drug (NSAID) will be commercially available in several weeks.

The FDA has approved Alcon Laboratories’ new drug application for nepafenac ophthalmic suspension 0.1% (Nevanac) for the treatment of pain and inflammation associated with cataract surgery. The company anticipates the ophthalmic nonsteroidal anti-inflammatory drug (NSAID) will be commercially available in several weeks.

The suspension contains a novel prodrug that rapidly penetrates ocular tissues. The approval was based on two multicenter, placebo-controlled studies involving more than 680 patients.

In these studies, more than 80% of patients treated with the nepafenac ophthalmic suspension were pain-free the day after surgery, compared with less than 50% in the placebo group, according to Alcon. After 14 days of treatment, 95% of patients taking the suspension were pain-free, compared with 45% of patients taking the placebo, the company said.