Anecortave Acetate Demonstrates Significant Long-Term Efficacy in Wet Age-Related Macular Degeneration Patients o New two-year data reveal prevention of vision loss and inhibition of lesion growth F

o New two-year data reveal prevention of vision loss and inhibition of lesion growth

Fort Worth, Texas August

18, 2003 Alcon, Inc. (NYSE: ACL) reported today that long-term use of its

investigational new drug, RETAANE 15 mg (anecortave acetate for depot

suspension), preserves vision, prevents severe vision loss and inhibits lesion growth in

patients with wet age-related macular degeneration (AMD).

L. Hudson, M.D., F.A.C.S., an ophthalmologist at the Retina Centers, P.C. in Tucson,

Arizona, and an investigator in the study, presented 24-month, phase II/III study data

today at the American Society of Retina Specialists (ASRS) annual meeting. This new

data adds to and confirms the previously reported 12 month findings which showed that a

15mg treatment of RETAANE has the potential to safely and effectively

preserve sight in and deliver tangible benefits to wet AMD patients. This is a significant

milestone toward an improved standard of care for these patients, said Dr. Hudson.

is one of the leading causes of blindness in the world. AMD destroys central vision, which

is used to read, drive and perform other activities that require fine, sharp vision.

Approximately 250,000 new U.S. cases of the wet or exudative form of AMD occur

annually. Wet AMD occurs when new, leaky blood vessels grow towards the center, or macula,

of the eye s light-sensitive inner layer, the retina. The resulting fluid

accumulation separates the retina from its anchoring tissue, resulting in damage that can

quickly lead to the loss of central vision.

24-month data reaffirm the potential value of RETAANE 15 mg for treating this

devastating, difficult to control disease, said Stella Robertson, Ph.D.,

Alcon s Vice President of Pharmaceutical Products Research and Development.

Because the treatment options for patients with wet AMD are so limited, the

potential RETAANE 15 mg brings could prove to be a major advance in fighting

works by slowing or stopping the growth of new blood vessels, which leads to less leakage

and less retinal damage. In the study, 73 percent of patients treated with

RETAANE 15 mg (anecortave acetate for depot suspension) had stable or

improved vision based on measures from the logarithm of the minimum angle of resolution

(logMAR) test, a standard AMD vision test, from baseline to 24 months after treatment,

significantly more than the 47 percent of patients in the placebo group (p=0.035).

treated with RETAANE 15 mg (anecortave acetate for depot suspension) had no

increase in growth of the classic component of the subfoveal choroidal neovascular

membrane (CNV) between months 12 and 24, and the total lesion size remained stable over

this period. Additionally, at 24 months, in the sub-group of patients with the more

aggressive, predominantly classic CNV lesions, no patients treated with

RETAANE 15 mg had severe vision loss (> 6 lines loss) compared to a

23 percent rate in the placebo group, (p=0.023).

received RETAANE 15 mg (anecortave acetate for depot suspension) or placebo

every six months, during an in-office procedure known as a posterior juxtascleral depot

(PJD). During PJD, the investigator uses a specially designed cannula to place the

suspension onto the outer surface of the back of the eye directly behind the macula. This

method of delivery allows the drug to diffuse across the sclera and choroid into the

macular portion of the retina over a period of six months. In contrast, other

investigational therapies require direct injection into the eye as frequently as nine to

to a study of PJD presented at ASRS by investigator Peter K. Kaiser, M.D., an

ophthalmologist at the Cole Eye Institute at the Cleveland Clinic in Ohio, this delivery

method was found to be an effective way to administer RETAANE 15 mg

(anecortave acetate for depot suspension). In more than 500 procedures performed in five

clinical trials to date, investigators found that PJD safely administered the drug over

the macula, delivered adequate drug levels for up to six months and did not cause any

identified clinically relevant safety issues. An independent safety committee that

provides ongoing review for these studies determined that no clinically relevant adverse

events related to the drug itself have been seen.

study results come at the end of a 24-month, placebo-controlled, dose-response clinical

trial, in which patients with wet AMD were randomly assigned to receive one of three

concentrations of the drug or a placebo; the therapy assignments remained unknown until

the study ended. After the initial patient visit, investigators had the option to re-treat

patients at six-month intervals.

in the study averaged 77 years of age. There were no statistically significant differences

between the therapy groups at baseline in logMAR visual acuity, total lesion size, or

percentage of patients with predominantly classic lesions. The trial included 18 sites and

128 patients. Of these 128 patients, 76 completed their 12-month visit, while 55 completed

their 24-month visit.

has moved ahead with the next step to gain regulatory approval of RETAANE 15

mg (anecortave acetate for depot suspension) by launching a phase III trial at more than

50 sites in the United States, Europe, Australia and Canada. Approximately 500 patients

have been enrolled in this study, which directly compares the effectiveness of

RETAANE 15 mg versus photodynamic therapy (PDT) using VISUDYNE* in patients

diagnosed with predominantly classic wet AMD.

is a degeneration of the macular region of the retina, the portion of the eye key to

central vision. The two main types of AMD are wet, or exudative, and

dry, or non-exudative. Although the wet form of AMD constitutes only 10 to 15

percent of all AMD cases, it is responsible for 90 percent of blindness attributable to

the condition. Wet AMD has no cure, but laser surgery is often used to seal

off the leaky vessels. As a rule, retinal damage is irreversible, so prompt

treatment is essential. Generally, AMD causes vision loss around age 55, and, if

untreated, can result in social blindness within two to three years.

Inc. 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.

*VISUDYNE is a registered trademark

press release contains forward-looking statements within the meaning of the Private

Securities Litigation Reform Act of 1995, relating principally to our ability to complete

clinical trials for Anecortave Acetate and file a New Drug Application (NDA) with the U.S.

Food and Drug Administration (FDA) and the expected benefits of Anecortave Acetate in

treating exudative age-related macular degeneration (AMD). 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