If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Difluprednate Emulsion Shows Similar Efficacy to Prednisolone Suspension in Treatment of Anterior Uveitis: Presented at ARVO By Ed Susman FORT LAUDERDALE, Fla -- May 7, 2009 -- Difluprednate ophthalmic emulsion 0.05% and prednisolone acetate suspension 1% demonstrate similar efficacy in the treatment of inflammatory anterior uveitis, researchers suggested here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting. "The advantage to treatment with [difluprednate ophthalmic emulsion, 0.05%] is that we can treat with fewer doses and get the same result," said principal investigator Robert J. DaVanzo, MD, Cornerstone Eye Care, High Point, North Carolina, speaking here at a poster presentation on May 5. "Less frequent dosing usually results in better compliance by patients," Dr. DaVanzo explained. "If you tell patients to apply something 8 times a day, it usually means they do it 4 times a day -- or maybe just twice a day." Prednisolone is administered 8 times a day, whereas difluprednate can be delivered 4 times a day. In this phase 3 clinical trial, 90 patients were titrated to lower and lower doses during the 42-day study. At the end of the study, the total symptom score among the 50 difluprednate patients was reduced 86% compared with a 76% reduction among the 40 patients on prednisolone. The difference did not reach statistical significance, the researchers noted. "[Difluprednate ophthalmic emulsion, 0.05%] is a more potent steroid," stated Dr. DaVanzo. "It also has an advantage in being an emulsion. A suspension has to be shaken vigorously, and many of our patients are elderly and cannot adequately shake the bottles, and, therefore can be underdosed." In the randomised, multicentre, double-masked noninferiority trial, both groups were treated with the test agent for 14 days, followed by 2 weeks of tapering at half the dose, and 2 weeks of follow-up. Subjects aged 2 years or older with endogenous anterior uveitis in at least 1 eye and more than 10 cells and a flare score of 2 or greater in the anterior chamber of that same eye were eligible for participation in the study. The primary endpoint was the difference from baseline in anterior-chamber cell grades between the treatment groups. "[Difluprednate ophthalmic emulsion, 0.05%] 4 times a day was noninferior to or numerically superior to prednisolone acetate suspension 1% administered 8 times daily in almost every efficacy parameter tested," Dr. DaVanzo said. "Treatment benefit was observed as early as day 3 and was sustained through 42 days." Clinically significant increases in intraocular pressure were noted in 6% of the difluprednate patients and in 5% of the prednisolone patients -- a nonsignificant difference, said Dr. DaVanzo. Five of the prednisolone patients (12.5%) withdrew from the study for lack of efficacy; none of the difluprednate patients quit the trial for lack of efficacy (P = .01). Funding for this study was provided by Sirion Pharmaceuticals.
[Presentation title: Durezol Compared to Pred Forte in the Treatment of Endogenous Anterior Uveitis. Abstract 2697-D1106]
|
