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New NSAID Nevanac gains U.S. marketing approval
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FORT WORTH, Texas — A topical, nonsteroidal drug for the treatment of pain and inflammation associated with cataract surgery was approved by U.S. regulators, 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 release.
The approval is based on two multicenter, placebo-controlled studies of more than 680 patients. Patients were given the drug three times daily beginning 1 day before surgery, continuing on the day of surgery and for the first 2 weeks of the postoperative period.
After topical administration, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug, according to labeling information for the drug. Amfenac is thought to inhibit the action of cyclooxygenase, the labeling states.
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. Of those treated with Nevanac, 91% had no clinically significant inflammation at day 14, compared with 47% in the placebo group.
For more on study results with nepafenac presented earlier this year, click here.
Alcon expects to launch Nevanac “in the next several weeks,” the press release said.