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Travatan/Timolol Fixed Combination Comparable to Safety Profile of the Two Single Agents Dosed Concomitantly

FORT WORTH, Texas, March 7 /PRNewswire-FirstCall/ -- Three-month data from several Phase III clinical trials on Travatan/Timolol Fixed Combination (TTFC), Alcon's investigational new drug to treat glaucoma, were presented this weekend at the American Glaucoma Society's annual meeting in Sarasota, Florida. Alcon has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for TTFC, which combines travoprost 0.004% and timolol 0.5% into a once-daily medication.

The data from one study demonstrated that TTFC reduced intraocular pressure (IOP) by up to 12 mmHg. The change in IOP produced by TTFC was 2 mmHg more than that produced by travoprost 0.004% alone at the 8 a.m. time point. At the 10 a.m. and 4 p.m. time points, TTFC reduced IOP between one and two mmHg more than travoprost 0.004% alone. The two other Phase III clinical trials compared the IOP lowering effect of TTFC to concomitant therapy, consisting of travoprost 0.004% dosed in the evening and timolol 0.5% dosed in the morning. TTFC was not statistically different from concomitant therapy at all 8 a.m. time points and at most, but not all, other measured time points.

The data presented from these three clinical trials demonstrated that TTFC showed a comparable safety profile to the two single agents dosed concomitantly, travoprost 0.004% and timolol 0.5%.

Stella Robertson, Ph.D., vice president of Pharmaceutical Products, Research and Development, Alcon, said, "In these clinical studies TTFC achieved similar IOP reduction as travoprost 0.004% and timolol 0.5% used concomitantly and reduced IOP compared to travoprost 0.004% alone. Importantly, it delivered these results without a medically significant increase in side effects to the patient."

About Glaucoma

While there are many causes of glaucoma, most cases are associated with increased intraocular pressure. Loss of vision is usually characterized by a gradual reduction in peripheral vision, which can lead to a tunnel vision effect. Glaucoma affects approximately 100 million people globally and is one of the leading causes of blindness in the world today. An estimated three million Americans have this sight-threatening disease. Because it is painless and advances gradually, many people who have glaucoma or elevated IOP have not been diagnosed. If detected and treated early, vision can usually be preserved.

The most common treatment for glaucoma is the use of prescription eye drops specifically developed to lower IOP. The two most widely prescribed classes of glaucoma medications are prostaglandin analogues and beta-blockers. Prostaglandin analogues, including travaprost 0.004%, currently account for over 40 percent of all glaucoma prescriptions written in the U.S., while beta-blockers, including timolol 0.5%, are the second most frequently prescribed class representing 24 percent of prescriptions.

Approximately 50% of all glaucoma patients in the U.S. use two or more medications to control their IOP. In the prostaglandin analogue segment, about 40-45 percent of patients augment that therapy with another glaucoma medication, with about half of them using a beta-blocker. A fixed combination that combines a prostaglandin analogue and a beta-blocker is not available in the U.S. today.

Source: Alcon

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