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NDA Filed for Timolol, Travoprost Combination To Treat Glaucoma

FORT WORTH, Texas, Jan. 25 /PRNewswire-FirstCall/ -- Alcon announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of its new drug application for a new eye medication for the treatment of glaucoma. The company also presented preliminary six week data from three of its ongoing Phase III clinical trials on the drug at the Royal Hawaiian Eye Meeting. The data from one of these studies demonstrated that Travoprost 0.004% + Timolol 0.5% Fixed Combination (TTFC) reduced intraocular pressure (IOP) by up to 12 mmHg. TTFC reduced IOP 2 mmHg more than travoprost 0.004% alone at the 8AM time point. At the 10AM and 4PM time points, TTFC reduced IOP between one and two mmHg more than travoprost 0.004% alone.

Alcon also presented preliminary data from two other Phase III clinical trials. These trials compared the IOP lowering effect of TTFC to concomitant therapy of travoprost 0.004% dosed in the evening plus timolol 0.5% dosed in the morning. TTFC was not statistically different from concomitant therapy at all the 8AM time points and at most of, but not all, the 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%. These results confirmed that TTFC was safe and well tolerated in the patients who participated in these Phase III trials.

Stella Robertson, Ph.D., vice president of Pharmaceutical Products, Research and Development said, "We believe the results of our clinical studies are compelling in that they demonstrate that TTFC may be able to achieve at least the same IOP reduction as travoprost 0.004% and timolol 0.5% used concomitantly, without a medically significant increase in side effects to the patient. We hear regularly from physicians that they would welcome a combination product like this to reduce the frequency of the dosing schedule and to potentially improve compliance with the therapeutic regimen they prescribe."

Glaucoma affects approximately 100 million people globally and it is one of the leading causes of blindness in the world today. An estimated 3 million Americans have this sight threatening disease. If detected and treated early, vision can usually be preserved. The most common treatment is the use of prescription eye drops specifically developed to lower IOP. The two most widely prescribed classes of glaucoma medications today 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 prescribed class representing 24 percent of prescriptions.

Approximately 50 percent 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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