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Ophthalmic emulsion may safely clear postop inflammation, reduce pain
J Cataract Refract Surg. 2009;35:26-34.
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Difluprednate ophthalmic emulsion administered two to four times daily reduced postoperative inflammation and pain with no serious side effects, according to a study.
"There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group," the study authors said.
The study included 438 patients: 111 received Durezol (difluprednate ophthalmic emulsion 0.05%, Sirion Therapeutics) twice daily, 107 received the agent four times daily and 220 received a placebo two or four times daily.
Difluprednate was introduced 1 day after unilateral ocular surgery and continued for 14 days. Dosing was followed by a 14-day tapering period and 7-day safety evaluation. Primary outcome measures were cleared anterior chamber inflammation, elimination of pain and incidence of adverse events, the authors said.
Both difluprednate regimens reduced postop inflammation and pain compared with placebo. A larger portion of patients receiving difluprednate had reduced inflammation and pain at 8 days and 15 days. In both difluprednate groups, 3% of patients had a significant increase in IOP of 10 mm Hg to 21 mm Hg; IOP increased in 1% of patients in the placebo group.
This study looked at the safety and efficacy of topical difluprednate 0.05% dosed either two or four times a day compared to placebo in the treatment of inflammation and pain associated with cataract surgery.
The take-home message of the study is that difluprednate 0.05% twice a day was as effective as four times a day in successfully treating inflammation associated with cataract surgery. Both dosing schedules achieved a reduction of over 80% of anterior chamber cells after 2 weeks of treatment. This effect was in patients that had moderate to severe inflammation defined as 10 or more anterior chamber cells at entry (24 hours after surgery).
The effect on clinical practice is that this steroid can be used in less frequent dosing protocols in conjunction with the less frequent dosing of the newer topical antibiotics and NSAIDs. Corticosteroids have been traditionally dosed four times a day. However, newer topical antibiotics and NSAIDs have been shown to be effective in protocols of two or three times a day. We now have a topical steroid to fit into this new regimen. The less frequent dosing is easier for patients and will result in better compliance.
– Edward J. Holland, MD
OSN Cornea/External Disease Board Member