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Alcon FOR IMMEDIATE RELEASE Alcon to Initiate New Anecortave Acetate Clinical Trials for Age-Related Macular Degeneration Studies Will Assess Effectiveness of Investigational Therapyin Slowing Progression from Dry to Wet

Key Takeaway: Alcon to Initiate New Anecortave Acetate Clinical Trials for Age-Related Macular Degeneration Effectiveness of Investigational Therapyin Slowing Progression from Dry to Wet Form Fort Worth, Texas November 13, 2003 Alcon, Inc. (NYSE:ACL) will initiate two new phase III studie

Full Press Release Details

Alcon to Initiate New Anecortave Acetate

Clinical Trials for Age-Related Macular Degeneration

Effectiveness of Investigational Therapyin
Slowing Progression from Dry to Wet Form
Fort Worth, Texas November
13, 2003 Alcon, Inc. (NYSE:ACL) will initiate two new phase III studies of
Retaane (anecortave acetate for depot suspension) for treatment of
age-related macular degeneration (AMD) the most common cause of blindness in people
over the age of 60. The new trials will evaluate the safety and efficacy of treatment
every six months with the investigational drug Retaane Depot versus placebo
in a group of patients with advanced dry (or non-exudative) AMD who are at risk of
progressing to wet (or exudative) AMD. After completion of enrollment, the studies will
occur over a period of four years and will include approximately 2,500 patients who will
be enrolled at 100 sites worldwide. Enrollment is scheduled to begin in January 2004.
Alcon stated that the U.S. Food and Drug Administration (FDA) has given Fast
Track designation to the development of Anecortave Acetate for this indication,
because it represents a significant unmet medical need for a serious condition.
new trials represent uncharted territory for AMD therapy, said Jason S. Slakter, MD,
of the Manhattan Eye, Ear and Throat Hospital and Chairman of the Anecortave Acetate
Clinical Study Group. Though not as severe a disease as the wet form of AMD, dry AMD
may progress into wet AMD and therefore lead to extensive vision loss. Development of a
treatment for people with dry AMD who have been identified as having high risk of
progressing to wet AMD could be a breakthrough for the disease.

What is AMD?

degeneration describes several eye disorders characterized by damage to the macula
the light-sensitive cells near the center of the retina at the back of the eye. The
macula is responsible for our ability to see with enough detail to read, drive, watch
television and perform other activities that require focused, straight-ahead vision. When
the cells of the macula degenerate and malfunction, the result is an increasing loss of
central vision. Today, AMD is the leading cause of blindness in industrialized nations,
primarily because there is a lack of effective treatments for the disease.
AMD accounts for up to 90 percent of all cases of AMD. It occurs when the light-sensitive
cells in the macula slowly die, gradually blurring central vision in the affected eye. Dry
AMD typically develops slowly. Vision loss may be mild at first, becoming more noticeable
over time. There is no approved medical treatment for dry AMD, and though it usually does
not result in severe loss of vision or blindness, people with the disease may have
difficulty recognizing faces and need additional light for close-up tasks like
reading. Over time, dry AMD can progress to the wet form of the disease.
AMD results from the rapid growth of abnormal blood vessels called choroidal
neovascular (CNV) lesions under and towards the center, or macula, of the retina,
the light-sensitive tissue in the back of the eye. As the fragile new vessels grow and
proliferate, they frequently leak blood and fluid that accumulates under and lifts the
macula. The resulting vessel growth and fluid accumulation separates the retina from its
anchoring tissue and causes rapid damage. Consequently, vision is distorted or destroyed.
About 200,000 new cases of wet AMD are reported each year in the United States.

Method of Action

Acetate belongs to a class of compounds known as angiostatic cortisenes. Anecortave
Acetate works by slowing or stopping the growth of new blood vessels, which leads to less
leakage and less retinal damage. Retaane 15 mg Depot is currently in clinical
trials to evaluate its safety and efficacy in the treatment of the wet form of AMD. A
recently completed two-year study in patients with wet AMD who received treatment with
Retaane 15 mg Depot every six months showed inhibition of all aspects of CNV
15 mg Depot is the only potential treatment for wet AMD that is administered onto the
outer surface of the back of the eye using a specially designed curved, blunt-tipped
cannula that does not pierce the eyeball. Unlike other investigational approaches to the
treatment of AMD, the method of delivery for Retaane Depot called
posterior juxtascleral depot or PJD avoids the risk of intraocular infection and
retinal detachment, the most common side effects associated with injecting therapeutic
agents directly into the eye. To date, over 700 patients have been treated with anecortave
acetate using PJD with no serious treatment-related side effects.
safety of the drug combined with the safety of posteror juxtascleral depot administration
and a dosing frequency of every six months make Retaane Depot very
appropriate for chronic use, said Donald J. D Amico, MD, a Retina Specialist at
the Massachusetts Eye and Ear Infirmary and Chairman of the Independent Safety Committee
for Anecortave Acetate. Taken together, these are extremely important factors in the
selection of a therapy for long-term studies such as these.
FDA s fast track designation is intended to address reviewing an investigational
therapy that could treat an unmet medical need for a serious or life-threatening
condition. The benefits of fast track status include: the opportunity to schedule more
frequent meetings with the FDA to receive feedback on development plans; the option to
submit a New Drug Application (NDA) piece-by-piece instead of all at once; and the option
of submitting substitute endpoints for the study evaluation purposes.

About Alcon

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.
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 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 forward-looking
statements. Factors that might cause future results to differ include, but are not limited
to, the following: we may never submit an NDA for Anecortave Acetate to the FDA, or
submission and/or approval of the NDA may take longer than we expect; treatments developed
by other companies may reach the market sooner or prove to be more effective than
Anecortave Acetate; challenges inherent in new product marketing; 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
Last updated: Nov 13, 2003