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A topical nonsteroidal drug for the treatment of pain and inflammation associated with cataract surgery was approved by U.S. regulators in late August, its manufacturer announced.
The Food and Drug Administration approved Nevanac (nepafenac ophthalmic suspension, Alcon) 0.1% after a priority 6-month review, a press release from Alcon said.
According to Alcon, Nevanac is the first ophthalmic nonsteroidal anti-inflammatory prodrug to receive FDA approval.
“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 Richard L. Lindstrom, MD, Chief Medical Editor of Ocular Surgery News, in the press release.
The approval is based on two multicenter, placebo-controlled studies of more than 680 patients total. Patients were given the drug three times daily beginning 1 day preop, continuing on the day of surgery and for the first 2 weeks of the postoperative period. A significantly higher percentage of patients (about 80%) in the treatment group reported no ocular pain the day after surgery, compared with about 50% receiving vehicle only, the labeling information states. After 2 weeks of treatment, 95% of patients were pain-free, compared with 45% in the vehicle group.
Alcon expects to launch Nevanac “in the next several weeks,” the press release said.