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Alcon files travoprost/timolol combo

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has accepted Alcon's NDA for a fixed combination of travoprost 0.004%/timolol 0.5% (TTFC) for the treatment of glaucoma, the firm announces Jan. 25. According to preliminary data presented at the Royal Hawaiian Eye Meeting in January, TTFC reduced intraocular pressure 2 mmHg more than travoprost alone at 8 a.m. in one study. In two other Phase III studies, TTFC was not statistically different from concomitant therapy at the 8 a.m. time points "and at most of, but not all, the other measured time points." Safety was comparable to concomitant dosing in all three studies. The firm estimates approximately 50% of U.S. glaucoma patients use two or more agents...

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