Full Press Release Details
New RETAANE Clinical Study Data Reported at Macula Society Meeting
FORT WORTH, Texas February
25, 2005 Alcon, Inc. (NYSE:ACL) reported the results of a clinical
pharmacokinetic (PK) study evaluating the effectiveness of a counter pressure device (CPD)
it developed to control reflux during the administration of RETAANE
15mg (anecortave acetate for depot suspension) by posterior juxtascleral depot (PJD).
The results of this PK study demonstrated that the CPD was effective in controlling drug
reflux in 100 percent of the study participants. Reflux occurs when a portion of the drug
leaks back out through the small incision in the conjunctiva during or immediately
following the PJD procedure. Henry L. Hudson, M.D. of Tucson, Ariz., and Donald Roy, M.D.
of Fresno, Calif., conducted the study. Allen C. Ho, M.D. of Philadelphia, Pa., presented
the data at the 28th Annual Macula Society Meeting in Key Biscayne, Fla.
addition to measuring reflux, the study also measured the concentration of drug in blood
plasma to confirm that effectively controlling reflux correlated with a higher level of
drug absorption. The results of this study supported this relationship, as the patients in
this study had higher concentrations of drug than did patients in previous trials who
experienced drug reflux. These data establish that PJD administration of
RETAANE depot using the CPD results in effective
delivery of the drug.
Alcon s new counter pressure device, reflux was effectively controlled during
administration of RETAANE in Dr. Hudson s and Dr.
Roy s study, said Dr. Ho. These positive results clearly demonstrate that
Alcon has successfully resolved drug reflux. Now physicians and patients can expect to
have a sufficient amount of drug to last for the entire six-month treatment
Robertson, PhD, vice president of ophthalmic research and development at Alcon, added,
This study responds to the FDA s specific request that we demonstrate that
reflux can be controlled with the counter pressure device, and its success should mitigate
any concern about reflux. We know from our phase III data that 57 percent of patients who
experienced no reflux and were treated with RETAANE
within six months maintained their vision, compared to 49 percent of patients treated with
VISUDYNE *; and these results met the seven percent non-inferiority
standard originally assigned to the trial. Furthermore, the overall results of our phase
III trial meet a 14 percent criterion more specific to the patients evaluated in the
addition the company announced the U.S. Food and Drug Administration (FDA) accepted its
New Drug Application (NDA) for RETAANE depot as fileable
and has confirmed a priority review assignment. Based on the date of its submission, Alcon
expects an FDA decision in late-May.
About AMD
macular degeneration is an eye disease that causes damage to the macula the
light-sensitive cells at the center of the retina at the back of the eye. The macula is
responsible for central vision, allowing people to perceive colors sharply and to see with
enough detail to read, drive, watch television and perform other activities that require
focused, straight-ahead vision. Central vision enables people to maintain independence in
are two types of AMD 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. Today, wet
AMD is the leading cause of blindness in industrialized nations in people over the age of
About RETAANE Depot
15mg (anecortave acetate for depot suspension) is an investigational treatment for
preserving the vision of patients with wet age-related macular degeneration (AMD), a
disease that affects as many as one in three people aged 75 or older. Anecortave acetate,
the active ingredient in RETAANE depot, is an
angiostatic cortisene that inhibits the abnormal growth of blood vessels a process
scientifically known as angiogenesis. RETAANE depot
works by blocking the effect of multiple angiogenic growth factors and by preventing the
weakening of blood vessel walls, which reduces the migration of cells that leads to the
formation of abnormal blood vessels. RETAANE depot is
administered onto the outer surface of the back of the eye at six-month intervals using a
procedure called posterior juxtascleral depot.
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. Alcon has been conducting
retinal research for more than 15 years and is the world s leading provider of
surgical equipment used by vitreoretinal specialists who treat patients with AMD and other
is a registered trademark of Novartis AG.
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 gain FDA approval of
RETAANE depot and to the expected benefits of
RETAANE depot 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 gain approval of RETAANE depot 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 RETAANE depot; 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
For information, contact:
MacHatton (Alcon Investor Relations)
Shannon Caudill, Porter
Novelli (Public Relations)