Full Press Release Details
Alcon Research, Ltd.
Alcon Releases Results for Anecortave Acetate
Therapy for Wet Age-Related Macular Degeneration
Fort Worth, TX, May 5, 2002 - Alcon Research, Ltd. reported preliminary
results today from its Phase II clinical trials demonstrating that anecortave
acetate, one of its key drugs under development, preserves or improves vision
in patients with the wet form of age-related macular degeneration (AMD). These
results, based on a six-month analysis of an ongoing 24-month trial, were
presented today by Jason Slakter, M.D. at the Annual Meeting of the
Association for Research in Vision and Ophthalmology (ARVO) in Fort
Lauderdale, Florida. Dr. Slakter is a retinal specialist at
Vitreous-Retina-Macula Consultants of New York and Clinical Professor of
Ophthalmology at the New York University School of Medicine.
Alcon Research, Ltd. is conducting two Phase II studies in the US and
Europe to assess the safety and efficacy of anecortave acetate for the
treatment of AMD as a single therapy or with photodynamic therapy (PDT). The
studies are both double-masked, randomized, placebo controlled, dose response
clinical trials and are similar in patient demographics, baseline logMAR
visual acuity and lesion location (sub-foveal). The single-therapy trial is
being conducted at 18 sites with 128 patients enrolled for 24 months; the
study with PDT was a six-month study with 136 patients at 11 sites. Anecortave
acetate is delivered around the back of the eye, where it diffuses across the
choroid into the macular portion of the retina. In the single-therapy study,
anecortave acetate treatments were administered every six months.
The six-month intent-to-treat analysis of the single-therapy study
demonstrated that anecortave acetate 15 mg had a better visual outcome than
placebo, based on mean change from baseline in logMAR visual acuity
(p=0.0032). Patients receiving anecortave acetate (15 mg) as a single therapy
experienced 25 per cent less loss of visual acuity (VA) than did patients
receiving placebo (88% vs 70%). The benchmark for VA was the avoidance of loss
of more than three lines of vision (15 letters by logMAR visual acuity).
Further, 18 percent of patients treated with anecortave acetate actually
improved their VA by at least two lines, whereas no patient who received
placebo had similar improvements in VA (p=0.025). Patients treated with
anecortave acetate 15mg also demonstrated a significantly less percent change
in lesion growth, including choroidal neovascularization, than patients
treated with placebo (p
Safety results were also presented at the ARVO meeting by Dr. Donald J.
D'Amico, Professor of Ophthalmology at Harvard Medical School. He reported
that no clinically relevant safety issues have occurred with anecortave
acetate during the studies, either from the compound itself or from the
delivery of it to the treatment area.
Age-related macular degeneration, commonly known as AMD, is a
degeneration of the macular region of the retina, which results in some degree
of visual loss. According to the Centers for Disease Control, AMD is one of
the leading causes of blindness in the world, and is the leading cause of
irreversible blindness in the United States. The Centers for Disease Control
estimate that 3.5 million people in the United States have some degree of AMD.
The age of onset of visual loss is generally 70, and the disease results in
the loss of central vision.
The two main types of AMD are "dry," or non-exudative, and "wet," or
exudative. Although the wet form of AMD constitutes only 10-15 percent of all
AMD cases, it is responsible for 90 percent of blindness attributable to this
condition. The Prevent Blindness America foundation and the National Eye
Institute report that over 1.6 million Americans age 50 and older have late
AMD. The causes of AMD are currently unknown, and no cure has been discovered,
although certain laser treatments and other procedures exist.
Additional results from both these studies will be discussed during ARVO,
May 5-8, 2002, in Fort Lauderdale, Florida.
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.
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 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 information or future
events or circumstances or otherwise.
For information, contact:
Doug MacHatton (Investor Relations)
News media inquiries: Mary Dulle (Corporate Communications)