Extravan
travoprost and timolol
Treatment for GlaucomaAlcon Files NDA for Combination Drug to Treat Glaucoma; Releases Preliminary Clinical Data at Major Ophthalmology Meeting
Fort Worth, TX - January 25, 2004 - 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 8 AM 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 8 AM 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.
Alcon, Inc. (NYSE:ACL) is the world's leading eye care company. Alcon, which has been dedicated to the ophthalmic industry for over 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye.
Caution Concerning Forward-Looking
Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
relating principally to the potential for TTFC to play a role in
the treatment of glaucoma. These statements involve known and
unknown risks, uncertainties and other factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performances or achievements
expressed or implied by our forward-looking statements. These
statements reflect the views of our management as of the date of
this press release with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Factors that might cause future results
to differ include, but are not limited to, the following: the U.S.
Food and Drug Administration may not approve our new drug
application or it may take longer than expected to receive
approval; treatments developed by other companies may reach the
market sooner or prove to be more effective than TTFC; we may have
to conduct additional studies to gain approval; the market
acceptance of TTFC may not be as great as expected; we may face
challenges and incur costs inherent in new product marketing; and
government regulation and legislation may affect the demand for and
revenues of TTFC, if any. You should read this press release with
the understanding that our actual future results may be materially
different from what we expect. Except to the extent required under
the federal securities laws and the rules and regulations
promulgated by the Securities and Exchange Commission, we undertake
no obligation to publicly update or revise any of these
forward-looking statements, whether to reflect new information or
future events or circumstances or otherwise.
For information about Alcon, contact:
Doug MacHatton (Investor Relations) 800-400-8599
News media and other inquiries: Mary Dulle (Public Relations)
817-551-8058
www.alconinc.com
Related Articles:
Alcon Receives Approvable Letter for Extravan - September 17, 2004
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