Nepafenac effective in controlling pain, inflammation after cataract surgery

WASHINGTON — A new non-steroidal anti-inflammatory drug had significantly higher cure rates, lower inflammation scores and fewer treatment failures in a trial comparing it to vehicle, said investigator Stephen S. Lane, MD.

Dr. Lane discussed clinical study results with nepafenac 0.1% in a presentation at the American Society of Cataract and Refractive Surgery meeting.

“Nepafenac is a prodrug with rapid corneal penetration that converts to amfenac in the eye,” he said. According to the drug’s developer, Alcon, nepafenac is the first prodrug NSAID being developed for ophthalmic use.

In the study presented by Dr. Lane 476 patients were dosed with nepafenac three times daily on the day before cataract surgery, the day of surgery and for 14 days postoperatively as well.

The cure rate was 62.6% with nepafenac, compared with 17.2% for vehicle by the last follow-up, he said. During all postoperative visits, patients dosed with nepafenac showed a significant reduction in cells, flare and cells plus flare, he said.

“By day 1, those on nepafenac had a twofold improvement in cells and flare [over] those on vehicle,” he said.

During a question-and-answer period, Dr. Lane said he believes nepafenac may be used as a standalone drug to control inflammation in patients who cannot take steroids, but in other patients it would probably be an adjunct to steroids.

Alcon, which plans to market nepafenac as Nevanac, announced during the ASCRS meeting that the Food and Drug Administration has accepted the company’s new drug application for the NSAID for the treatment of pain and inflammation associated with cataract surgery. The application has been granted priority review.

According to an Alcon press release, in clinical trials more than 80% of patients treated with Nevanac suspension were pain-free on day 1, compared with 40% to 50% in the placebo group. By day 14, approximately 95% of patients were pain-free when treated with the drug, compared with 45% to 60% of patients in the placebo group. Regarding inflammation control, more than 85% of patients treated with Nevanac suspension had no clinically significant inflammation at day 14, compared to approximately 49% of patients in the placebo group.