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news.Alcon has received FDA approval for its new drug application for Nevanac suspension 0.1% for the treatment of pain and inflammation associated with cataract surgery. The approval came after a priority six month review.
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Nevanac suspension contains a novel prodrug that rapidly penetrates ocular tissues. It is the first ophthalmic non-steroidal anti-inflammatory prodrug to receive FDA approval. Alcon expects Nevanac suspension to be commercially available in the next several weeks.
“The prodrug structure of Nevanac suspension offers significant advantages to ophthalmic surgeons. Nevanac suspension provides unique, target-specific activity that promotes penetration into the ocular tissues of most concern to ophthalmologists. This maximizes efficacy at the target sites of pain and inflammation following cataract surgery,” said Dr Richard Lindstrom, adjunct professor emeritus at the department of ophthalmology, University of Minnesota.
The approval is based on results of two multi-center, placebo-controlled studies involving over 680 patients. 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% of patients were pain free, compared to 45% of patients in the placebo group.