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Alcon For immediate release: Alcon Reports Additional Clinical Data on Potential New Glaucoma Drug Fort Worth, Texas

Key Takeaway: For immediate release: Alcon Reports Additional Clinical Data on Potential New Glaucoma Drug Fort Worth, Texas March 7, 2004 Three-month data from several Phase III clinical trials on Travatan/Timolol Fixed Combination (TTFC), Alcon s investigational new drug to treat glaucom

Full Press Release Details

For immediate release:

Alcon Reports Additional Clinical Data on Potential New Glaucoma Drug

Fort Worth, Texas March 7, 2004 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.
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.
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%.
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.
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.
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
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.
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.
about Alcon, contact:
Doug MacHatton (Investor Relations)
and other inquiries: Suzie DeMent (Public Relations)
Last updated: Mar 7, 2004