“This study’s findings underscore the importance of XALACOM in the arsenal of IOP lowering medications,” said Dr. Feldman. “Fixed combination therapies may be key to improving compliance among patients who do not respond to monotherapy, and in this study XALACOM was more effective than Cosopt.” The study – conducted at 30 eye centers in the United States on 251 patients with primary open angle glaucoma or ocular hypertension – was a randomized, parallel group, masked-evaluator, multicenter comparison of XALACOM and Cosopt. After three months of treatment, mean diurnal (+/- standard error of the mean) IOP reduction from baseline was 9.4 +/- 0.27 mmHg for XALACOM and 8.4 +/- 0.26 mmHg for Cosopt. XALACOM recorded a mean difference in IOP reduction of 1.00 mmHg versus Cosopt. The difference was statistically significant (p<0.005).
While both drugs were well tolerated locally and systemically, three times as many patients treated with Cosopt reported eye pain --14.1% (n=18) with Cosopt versus 4.0% (n= 5) with XALACOM.
Additionally, more patients reported eye irritation with Cosopt (7.8%, n=10) than with XALACOM (5.6%, n=7). Taste disturbance was the most frequently reported systemic adverse event with Cosopt (3.1%, n=4), but was not reported by any patients receiving XALACOM.
To date, XALACOM has been approved in the UK, Norway, Ireland, Hungary, Denmark, Belgium, Switzerland, Sweden, Finland, Netherlands, Germany, Italy, Austria, Venezuela, and Mexico. In these countries, XALACOM is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers. The most frequently reported adverse events with XALACOM in clinical trials were eye irritation, eye redness, changes to the clear surface that covers the front of the eye, inflammation of the membrane that covers the eye and lines the inner surface of the eyelid, eyelid inflammation, eye pain, headache, and skin rash. Darkening, thickening and lengthening of eye lashes and darkening of eye color (increase in the amount of brown color) were also noted.
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