Full Press Release Details
Alcon Receives FDA Approval for a SupplementalList of Susceptible Pathogens for VIGAMOX Ophthalmic Solution
Fort Worth, TX, April 26, 2004 Alcon, Inc.
(NYSE:ACL) announced today that it has received U.S. Food and Drug Administration (FDA) approval to
add a supplemental list of susceptible pathogens to its VIGAMOXTM ophthalmic
solution in vitro labeling. The addition of these pathogens to the VIGAMOX labeling further
demonstrates the breadth of coverage and potency that has made VIGAMOX the most widely prescribed
ophthalmic fluoroquinolone on the market today.
solution will now have an additional 22 pathogens added to the in vitro efficacy section
of its package insert, including atypical mycobacteria (Mycobacterium avium, Mycobacterium marinum)
and Propionibacterium acnes). This will result in Vigamox providing the broadest spectrum in
the ophthalmic fluroquinolone category.
addition of these supplemental pathogens reinforces the excellent potency of VIGAMOX . At the
same time, recent human studies clearly demonstrate the therapeutic penetration of VIGAMOX solution
into relevant ocular tissues, said Barry A. Schlech, Ph.D., Alcon Vice President, Pharmaceutical Technology.
The pathogens newly added to the VIGAMOX package insert are:
| Listeria monocytogenes | Neisseria gonorrhoeae | ||
| Staphylococcus saprophyticus | Proteus vulgaris | ||
| Streptococcus agalactiae | Pseudomonas stutzeri | ||
| Streptococcus mitis | Clostridium perfringens | ||
| Streptococcus Groups C, G and F | Propionibacterium acnes | ||
| Acinetobacter baumannii | Chlamydia pneumoniae | ||
| Acinetobacter calcoaceticus | Legionella pneumophila | ||
| Citrobacter freundii | Mycobacterium avium | ||
| Citrobacter koseri | Mycobacterium marinum | ||
| Enterobacter aerogenes | Mycoplasma pneumoniae | ||
| Enterobacter cloacae | |||
| Morganella morganii |
solution is the only fourth-generation fluoroquinolone eye drop formulated at a 0.5% concentration,
providing high drug concentration throughout relevant ocular structures. Its near-neutral pH of 6.8
provides for ocular comfort. VIGAMOXTM is potent enough to exceed U.S.
Pharmacopoeia preservative efficacy test requirements without the need for benzalkonium chloride.
than one million prescriptions for VIGAMOX solution have been dispensed in the U.S. since it
was introduced last spring. The potency and penetration of VIGAMOX combine with a low rate of
ocular adverse events to provide a high degree of clinical confidence in the safety and efficacy of
this product. In the multi-center clinical trials involving VIGAMOX , the most common ocular
side effects occurring in approximately 1 to 6 percent of patients, were conjunctivitis, decreased visual
acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival
hemorrhage and tearing.
Inc. is the world s leading eye care company. Alcon, which has been dedicated to the ophthalmic industry
for more than 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
The active ingredient in VIGAMOX , moxifloxacin
hydrochloride 0.5%, is licensed to Alcon, Inc. by Bayer AG.
Caution Concerning Forward-Looking Statements.
This press release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties
and other factors which 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, competition from other drugs already on the market
or competitive drugs that reach the market in the future, challenges inherent in new product manufacturing
and marketing, developments in legal cases and government regulation and legislation. 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, contact:
Doug MacHatton (Alcon Investor Relations)
Mary Dulle (Alcon Public Relations)