Alcon Receives FDA Approval for a Supplemental List of Susceptible Pathogens for VIGAMOX Ophthalmic Solution.

Business Editors/Health/Medical Writers

FORT WORTH, Texas--(BUSINESS WIRE)--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 VIGAMOX(TM) ophthalmic solution in vitro labeling. The addition of these pathogens to the VIGAMOX(TM) labeling further demonstrates the breadth of coverage and potency that has made VIGAMOX(TM) the most widely prescribed ophthalmic fluoroquinolone on the market today.

VIGAMOX(TM) 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.

"The addition of these supplemental pathogens reinforces the excellent potency of VIGAMOX(TM). At the same time, recent human studies clearly demonstrate the therapeutic penetration of VIGAMOX(TM) solution into relevant ocular tissues," said Barry A. Schlech, Ph.D., Alcon Vice President, Pharmaceutical Technology.

The pathogens newly added to the VIGAMOX(TM) package insert are:

    Listeria monocytogenes
    Staphylococcus saprophyticus
    Streptococcus agalactiae
    Streptococcus mitis
    Streptococcus Groups C, G and F
    Acinetobacter baumannii
    Acinetobacter calcoaceticus
    Citrobacter freundii
    Citrobacter koseri
    Enterobacter aerogenes
    Enterobacter cloacae
    Morganella morganii
    Neisseria gonorrhoeae
    Proteus vulgaris
    Pseudomonas stutzeri
    Clostridium perfringens
    Propionibacterium acnes
    Chlamydia pneumoniae
    Legionella pneumophila
    Mycobacterium avium
    Mycobacterium marinum
    Mycoplasma pneumoniae

VIGAMOX(TM) 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. VIGAMOX(TM) is potent enough to exceed U.S. Pharmacopoeia preservative efficacy test requirements without the need for benzalkonium chloride.

More than one million prescriptions for VIGAMOX(TM) solution have been dispensed in the U.S. since it was introduced last spring. The potency and penetration of VIGAMOX(TM) 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(TM), 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.

Alcon, 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 of the eye.

The active ingredient in VIGAMOX(TM), moxifloxacin hydrochloride 0.5%, is licensed to Alcon, Inc. by Bayer AG.

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