Nepafenac facilitates re-epithelialization and early pain reduction following PRK

Key Points

In addition, pain relief occurred earlier in patients randomly assigned to receive nepafenac compared with those patients receiving ketorolac or bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals), said John E. Sutphin Jr., MD.

"NSAIDs have been used for a long time in patients who underwent PRK, which was one of the early indications approved by the FDA for diclofenac sodium [Voltaren, Novartis Ophthalmics]. After nepafenac, a new NSAID, was approved in 2005, reports of problems associated with that drug and re-epithelialization following PRK began to appear in the literature," Dr. Sutphin said.

Dr. Sutphin and colleagues evaluated the effects of the drugs on corneal healing, primarily based on closure of the epithelial defect, and patients' subjective complaints of pain in each eye. The study was performed at Durrie Vision, Kansas City. A total of 29 patients (58 eyes) were included. The patients underwent either standard or bilateral custom PRK with an excimer laser system (LADARVision 4000, Alcon Laboratories).

The NSAIDs were administered concurrently with the antibiotic drugs that are normally given, Dr. Sutphin explained. Nepafenac was given with moxifloxacin HCl ophthalmic solution 0.5% (Vigamox, Alcon Laboratories); gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan) was given with ketorolac and bromfenac. All drugs were administered three times daily for 1 week to allow for standardization and masking during the study.

A bandage contact lens was used after the PRK procedure in all cases. Patients were taken to another exam room to determine pain level and for placement of the first dose of the NSAID/antibiotic combination, said Dr. Sutphin.

Patients returned for examination each day after PRK. The contact lens was removed, and the ocular surface was stained with a preserved solution of fluorescein.

"The epithelial defect was measured and sized every day. However, the end point was really the day of closure of the defect, rather than attempting to grade the overall rate of closure of the defect," Dr. Sutphin stated.

Patients provided pain feedback on days 1 and 3 postoperatively on an analogue pain scale, and they compared their responses with baseline to measure the changes in pain over time.

Dr. Sutphin said patients typically experienced closing of the epithelial defect in 4 days after PRK. "Closure of the epithelial defect ranged from as early as 3 days to as late as 13 days after PRK," he reported.

Investigators found no difference in the rate of healing of the epithelial defect between nepafenac (mean time to re-epithelialization, 5.50 days [± 1.59 SD; range, 3 to 9 days]) and ketorolac (mean time to re-epithelialization, 5.62 days [± 1.23; range, 4 to 8 days]), but they found delayed healing with bromfenac (mean time to re-epithelialization, 7.25 days [± 2.53; range, 4 to 13 days]).

Nepafenac showed a significant effect on pain relief on day 1 (decrease 1 to 1.13, p = 0.0146). Ketorolac and bromfenac did not significantly reduce pain until day 3 (–0.88 and –0.83, respectively, p < 0.05).