Business Wire
Alcon, Inc. (NYSE: ACL) released today the three-month interim
results of the first controlled clinical study of anecortave acetate
administered as an anterior juxtascleral depot in the sub-Tenon's
space to reduce intraocular pressure in patients with open-angle
glaucoma. The data were presented in a poster at the World Glaucoma
Congress in Singapore.
In this 12-month proof of concept study, 85 patients were randomly
assigned to one of four arms: 3mg, 15mg or 30mg of anecortave acetate
or vehicle. Prior to enrolling in the study, all patients had been
diagnosed with open-angle glaucoma, had experienced glaucomatous
visual field changes and had off-therapy intraocular pressures between
24 mmHg and 36 mmHg. One injection of drug or vehicle was administered
to each patient and intraocular pressures were assessed at two weeks,
six weeks and at month three. The study will continue with full
clinical assessments through the six-month period, with safety
follow-up through the conclusion of the study.
The primary conclusion of the poster was that anecortave acetate
demonstrated potential for prolonged reduction of intraocular pressure
in a significant percentage of patients following a single
administration of the drug for all concentrations versus vehicle at
month three (ANOVA, p less than 0.05). On a combined basis, 38 percent
of patients in the active arms were classified as treatment successes
at three months, compared to 24 percent of patients in the vehicle
arm. In the highest dose (30mg), 50 percent of patients were defined
as treatment successes at three months. On a combined basis, the mean
intraocular pressure reduction in the three active arms at three
months was 7.2 mmHg, compared to 1.4 mmHg for the vehicle arm
(p=0.0014). The poster presented data from the study on an intent to
treat basis.
Additional data from the poster revealed that mean intraocular
pressure declined in all three active arms and the vehicle arm at the
two week point, although there were no statistical differences at this
time point. However, the mean intraocular pressure decline in the
three active arms was maintained at the three month time point, while
mean intraocular pressure in the vehicle arm essentially returned to
baseline by month three. Mean intraocular pressures at month three
declined two percent for the vehicle arm compared to 15 percent for
the 3mg arm (p=0.0536), 16 percent for the 15mg arm (p=0.0526) and 19
percent for the 30mg arm (p=0.0120).
The poster noted that the study was designed very conservatively
to ensure patient safety in a study that involved glaucoma patients
with confirmed vision loss and included a vehicle group. This study
used a pre-defined intraocular pressure target for continuation in the
study (less than/=21 mmHg), which imparted a negative bias toward
demonstrating an overall beneficial treatment effect. This resulted in
some patients exiting the study because their intraocular pressures
rose above 21 mmHg, even though their intraocular pressures were much
lower than when they entered the study. This appropriately
conservative design reduced the number of patients that reached the
three month endpoint, thereby preventing the achievement of the
pre-defined primary endpoint of this small study.
In terms of safety, the most frequently reported adverse events
included eye pain, foreign body sensation and blurred vision. Nine of
the 14 reports of eye pain were associated with the injection and no
patients discontinued from the study due to an adverse event. The four
serious adverse events reported were stroke, irregular heart rate,
uterine polyp and kidney stone, none of which were related to the
study drug or procedure and there was no dose relationship evident in
the safety data.
"The results of this first controlled clinical study of anecortave
acetate for glaucoma are encouraging because they show that with one
injection the drug works for at least three months in a significant
number of glaucoma patients to lower pressure by clinically relevant
amounts," said Scott Krueger, PhD, Alcon's vice president, R&D,
Pharmaceutical Development. "In addition to these positive
indications, we also learned more about the drug that will help us
design additional studies that we believe will become the basis for
filing an anticipated new drug application with the FDA in 2009."
About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of
$4.9 billion in 2006. Alcon, which has been dedicated to the
ophthalmic industry for 60 years, researches, develops, manufactures
and markets pharmaceuticals, surgical equipment and devices, contact
lens care solutions and other vision care products that treat
diseases, disorders and other conditions of the eye. Alcon's majority
shareholder is Nestle, S.A., the world's largest food company.