BUSINESS WIRE
WASHINGTON--(BUSINESS WIRE)--Alcon, Inc. (NYSE: ACL) released today the primary efficacy and safety
results of the second controlled proof of concept 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. These initial data were
presented at a clinical investigator’s meeting
held in association with the annual meeting of the American Glaucoma
Society in Washington, DC.
In this safety and efficacy study, 89 patients were randomly assigned to
one of three arms: 7.5mg of anecortave acetate dosed with 0.25 mL of 30
mg/mL suspension, 15mg of anecortave acetate dosed with 0.5 mL of
30mg/mL suspension or 0.5 mL of vehicle. Prior to enrolling in the
study, all patients had been diagnosed with open-angle glaucoma, had
confirmed visual field changes and had off-therapy intraocular pressures
(IOP) 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, with month three predefined as
the visit for primary efficacy. The study design also allowed for a
patient to be retreated if more than 42 days had passed since the last
administration of anecortave acetate and the patient’s
intraocular pressure exceeded 18 mmHg in two consecutive visits
scheduled one week apart. The study will continue with clinical
assessments at six-week intervals, potentially through month twenty
four. The presented results are based on the intent to treat data set of
all 89 patients.
As explained during the presentation, the primary conclusion was that
both the 7.5 mg and 15 mg doses of anecortave acetate demonstrated
statistically significant lower mean IOP than vehicle at the month three
primary efficacy end-point (ANOVA p <
0.05). Additional data in the presentation supported the activity of
anecortave acetate in lowering IOP. Approximately 55 percent of patients
in the 7.5 mg and the 15 mg arms who were treated with anecortave
acetate according to the study design were deemed successes at month
three. These data contrast with the vehicle treatment group, where
approximately 50 percent of patients were treatment failures by week 2
and two patients (6.4 percent) were treatment successes at month three.
Treatment success was pre-defined in the study as maintenance of IOP at
or below the 21 mmHg. Taken together, these data support the activity of
anecortave acetate and also the company’s
prior decision to conduct additional clinical trials involving higher
concentrations of drug.
In terms of safety, the most frequently reported adverse events were
related to the procedure and included eye pain, foreign body sensation,
hyperemia and blurred vision, which were reported at an incidence of 5
percent to 15 percent. The most frequently reported events related to
test article were conjunctival deposits and eye pain which were reported
at an incidence of less than 5 percent.
“The safety and efficacy demonstrated in this
second controlled clinical study of anecortave acetate are encouraging
because they confirm a prolonged treatment benefit for anecortave
acetate administered by anterior juxtascleral delivery,”
said Scott Krueger, PhD, Alcon’s vice
president, R&D, Pharmaceutical Development. “These
results, together with our recently conducted Phase I safety evaluation
of larger doses and injection volumes, allows us to proceed in 2008 with
studies that evaluate higher doses and injection volumes in our Phase
II/III clinical development program.”
About Alcon
Alcon, Inc. is the world’s leading eye care
company, with sales of $5.6 billion in 2007. 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 Nestlé, S.A., the
world’s largest food company.
Caution Concerning Forward-Looking Statements. This
press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, including relating
to the potential for anecortave acetate to be approved by the FDA and
other regulatory agencies for the successful treatment of glaucoma. 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, anecortave acetate
may not show the same effect in future studies, it may take more time
than anticipated to obtain approval or approval may never be obtained,
the procedure to administer the drug is different from current therapy,
challenges inherent in new product manufacturing and marketing,
litigation risks and government reimbursement, 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 an 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.