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Recent Analyses Suggest That Treatment With Macugen(R) (pegaptanib sodium injection) May Provide Better Results for Patients With Early Stage Neovascu6 October 2005
Eyetech Pharmaceuticals, Inc.
(Nasdaq: EYET) and Pfizer Inc (NYSE: PFE) announced today that exploratory
analyses of the VISION (VEGF Inhibition Study in Ocular Neovascularization)
study suggest that treatment with Macugen(R) (pegaptanib sodium injection)
0.3 mg may provide better results in patients with early stage neovascular
age-related macular degeneration (AMD) compared to the overall VISION study
population. These findings were published in the October issue of Retina and
will be presented at the American Academy of Ophthalmology meeting on
October 18, 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050407/EYETLOGO )
Early diagnosis of neovascular AMD is critical since the disease can
rapidly lead to impaired visual function. Neovascular AMD is the leading
cause of severe vision loss among people aged > 60 years. Many patients with
neovascular AMD experience severe vision loss rapidly, with 1 in 10 people
losing vision within 3 months and 1 in 3 people losing vision within 2 years.
The subgroup analyses suggest that for patients with early disease
receiving Macugen 0.3 mg, responder rates (loss of <15 letters of visual
acuity) were higher than previously seen in the overall Macugen 0.3 mg group
in the VISION study (76% and 80% in the two early disease groups, compared
with 70% in the overall 0.3 mg Macugen group). In addition, 12% and 20% of
Macugen-treated patients in the two early disease subgroups gained 3 or more
lines of vision compared with 4% and 0%, respectively, in the usual care group
(compared with 6% Macugen vs. 2% usual care in the overall VISION study).
"These analyses suggest that treatment with Macugen early in the course of
disease may provide better results for AMD patients," said lead study author
Christine R. Gonzales, M.D., Assistant Professor of Ophthalmology, Jules Stein
Eye Institute and Dept. of Ophthalmology, David Geffen School of Medicine at
UCLA. "Furthermore, it suggests that early diagnosis, rapid referral and more
timely treatment may be important factors in order to achieve optimal
results."
Since the VISION study was not designed to evaluate these subgroup
responses, future studies are needed to prospectively investigate the impact
of treatment with Macugen for early stage neovascular AMD.
Treatment of Early Disease with Macugen
To assess Macugen's efficacy in treating earlier manifestations of
neovascular AMD, these analyses identified VISION study participants with
early disease characteristics (defined below), and assessed their visual
outcomes at week 54. Only patients from the 0.3 mg Macugen-treated group, or
those receiving sham injections, were included in these retrospective
analyses.
Although a universally accepted definition of early disease related to
neovascular AMD does not exist, for these analyses, the following
characteristics were used to classify study subjects with early onset of
neovascular AMD:
- Group 1 subjects: (1) lesion size < 2 disc areas (DA), (2) baseline
visual acuity (VA) greater than or equal to 54 ETDRS letters, (3) no
prior photodynamic therapy (PDT) or thermal laser photocoagulation to
the lesion, and (4) absence of scarring or atrophy within the lesion
- Group 2 subjects: (1) occult with no classic choroidal
neovascularization (CNV), (2) absence of lipid, and (3) better VA at
baseline in the fellow eye, i.e., worse VA at baseline in the study eye
By this definition, a few patients met the criteria for inclusion in both
groups.
Group 1 Results
In Group 1, for the primary endpoint in the VISION study (measured as the
loss of < 15 ETDRS letters or approximately 3 lines on the study eye chart)
the responder rate at week 54 was 76% (26/34) in subjects treated with
Macugen, compared with 50% (14/28) in the group receiving sham injections. For
a secondary endpoint in the VISION study, at week 54, 12% (4/34) of those
treated with Macugen gained 3 or more lines of vision, compared with 4 %
(1/28) of those who received sham injections.
Group 2 Results
In Group 2, for the primary endpoint in the VISION study (measured as the
loss of < 15 ETDRS letters or approximately 3 lines on the study eye chart),
the responder rate at week 54 was 80% (24/30) in subjects treated with
Macugen, compared with 57% (20/35) in the group receiving sham injections. For
a secondary endpoint in the VISION study, at week 54, 20% (6/30) of those
treated with Macugen gained 3 or more lines of vision, compared with 0% (0/35)
of subjects who received sham injections.
Retina is published by Lippincott Williams & Wilkins. For more
information please go to http://www.retinajournal.com. The full citation for this
article is: The VEGF Inhibition Study in Ocular Neovascularization
(V.I.S.I.O.N.) Clinical Trial Group. Enhanced Efficacy Associated with Early
Treatment of Neovascular Age-Related Macular Degeneration with Pegaptanib
Sodium: An Exploratory Analysis. Retina 2005;25:815-827
About Age-Related Macular Degeneration
AMD is a chronic, progressive disease of the central portion of the retina
called the macula, resulting in the loss of central vision. The most common
symptoms are a central blurred or blank spot, distortion of objects or simply
blurred vision. Peripheral vision usually remains intact. AMD is classified
into two forms: atrophic, referred to as dry AMD, and neovascular or wet AMD.
In neovascular AMD, abnormal blood vessels grow and leak into the macula,
resulting in loss of vision. Neovascular AMD is the more severe form of the
disease and progresses more rapidly than the dry type. Although it accounts
for only about 10-15% of all macular degeneration cases, neovascular AMD is
responsible for 90% of blindness caused by the disease.
About Macugen
Macugen is indicated in the United States for the treatment of neovascular
age-related macular degeneration (neovascular AMD) and is administered in a
0.3-mg dose once every six weeks by intravitreal injection. Macugen is a
pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor
(VEGF). VEGF is a protein that plays a critical role in angiogenesis (the
formation of new blood vessels) and increased permeability (leakage from blood
vessels), two pathological processes that contribute to the vision loss
associated with neovascular AMD.
Macugen is also available for neovascular AMD patients in Canada. Macugen
is approved in Brazil and has been filed for approval in twelve additional
countries.
For full prescribing information about Macugen, please visit
http://www.macugen.com.
Important Safety Information
Macugen is contraindicated in patients with ocular or periocular
infections.
Intravitreal injections including those with Macugen have been associated
with endophthalmitis. Proper aseptic injection technique -- which includes use
of sterile gloves, a sterile drape, and a sterile eyelid speculum (or
equivalent) -- should always be utilized when administering Macugen. In
addition, patients should be monitored during the week following the injection
to permit early treatment, should an infection occur.
Increases in intraocular pressure (IOP) have been seen within 30 minutes
of injection with Macugen. Therefore, IOP as well as the perfusion of the
optic nerve head should be monitored and managed appropriately.
Serious adverse events related to the injection procedure occurring in <1%
of intravitreal injections included endophthalmitis, retinal detachment, and
iatrogenic traumatic cataract.
Most frequently reported adverse events in patients treated for up to two
years were anterior chamber inflammation, blurred vision, cataract,
conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye
pain, hypertension, increased IOP, ocular discomfort, punctate keratitis,
reduced visual acuity, visual disturbance, vitreous floaters, and vitreous
opacities. These events occurred in approximately 10% to 40% of patients.
About Eyetech Pharmaceuticals, Inc.
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that
specializes in the development and commercialization of novel therapeutics to
treat diseases of the eye. Eyetech's initial focus is on diseases affecting
the back of the eye. Eyetech is commercializing Macugen(R) (pegaptanib sodium
injection) with Pfizer Inc for the treatment of neovascular AMD. Macugen is
also being studied for the treatment of diabetic macular edema and retinal
vein occlusion.
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines for human and animals in many of the world's best-known
consumer brands. For more information about Pfizer, please visit
http://www.pfizer.com.
Eyetech Safe Harbor Statement
This press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than statements of
historical facts, included in this press release regarding our plans and
objectives of management are forward-looking statements. We may not actually
achieve the plans, intentions or expectations disclosed in our forward-looking
statements and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking statements we
make. Various important factors could cause actual results or events to differ
materially from the forward-looking statements that we make, including risks
related to: maintaining acceptance of Macugen in the medical community, by
patients receiving therapy and by third party payors; supplying sufficient
quantities of Macugen to meet anticipated market demand; the impact of
competitive products; our dependence on third parties to manufacture Macugen;
new information arising out of clinical trial results; our dependence on our
strategic collaboration with Pfizer; and obtaining, maintaining and protecting
the intellectual property incorporated into Macugen. These and other risks are
described in greater detail in the "Risk Factors" section of our most recent
quarterly report on Form 10-Q filed with the SEC. Our forward-looking
statements do not reflect the potential impact of any future acquisitions,
mergers, dispositions, joint ventures or investments we may make. We do not
assume any obligation to update any forward-looking statements.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of October 05, 2005. The
Company assumes no obligation to update any forward-looking statements
contained in this release as a result of new information or future events or
developments.
This release contains forward-looking information regarding the efficacy
of Macugen that involves substantial risks and uncertainties. A description of
these risks and uncertainties can be found in the Company's Annual Report on
Form 10-K for the fiscal year ended December 31, 2004 and in its reports on
Forms 10-Q and 8-K.
Source: PR Newswire
All trademarks and copyrighted information contained herein are the property of their respective owners.
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