EXHIBIT 99.2
[EYETECH LOGO]
FOR IMMEDIATE RELEASE
MEDIA CHRIS SMITH
CONTACT: PUBLIC RELATIONS & CORPORATE COMMUNICATIONS
EYETECH PHARMACEUTICALS, INC.
Office: (212) 824-3203
Mobile: (973) 489-5076
E-mail: chris.smith@eyetech.com
INVESTOR GLENN SBLENDORIO
CONTACT: CHIEF FINANCIAL OFFICER
EYETECH PHARMACEUTICALS, INC.
Office: (212) 824-3121
E-mail: glenn.sblendorio@eyetech.com
MACUGEN(R) (PEGAPTANIB SODIUM INJECTION) STUDIED IN TREATMENT OF DIABETIC
MACULAR EDEMA (DME) AND OTHER DIABETIC RETINOPATHY LESIONS
Improvement in diabetic retinopathy score noted in review of retinal photographs
Phase 2/3 studies will examine potential role of Macugen in both diabetic
macular edema (DME) and progression of diabetic retinopathy
NEW YORK, MAY 5, 2005 - EYETECH PHARMACEUTICALS, INC. (NASDAQ: EYET) announced
today that imaging data from a Phase 2 study of Macugen(R) (pegaptanib sodium
injection) in diabetic macular edema (DME) showed a reversal of capillary
microaneurysms, retinal ischemia and neovascularization - all important signs of
diabetic retinopathy. These new preliminary observations from the Macugen Phase
2 DME trial were presented today at the 2005 Association for Research in Vision
and Ophthalmology annual meeting in Fort Lauderdale, Fla. Macugen is indicated
in the United States for the treatment of neovascular age-related macular
degeneration (neovascular AMD) and is not approved for the treatment of DME. For
full prescribing information about Macugen, please visit www.macugen.com.
"Researchers reviewed photographs of the retina and noted evidence of regression
of retinal neovascularization and other signs of diabetic retinopathy in
patients treated with Macugen. We also found an improvement on the diabetic
retinopathy severity scale, which suggests that Macugen may have helped slow or
even reverse the progression of the disease," said Larry Singerman, M.D.,
Clinical Professor of
Ophthalmology at Case University School of Medicine and President of Retina
Associates of Cleveland. "While no final conclusions can be drawn from these
preliminary and limited data as to the efficacy of Macugen in diabetic
retinopathy, we are encouraged by the potential implication of these findings,
which are consistent with our current understanding of the role of VEGF in
diabetic retinopathy. We look forward to future research to confirm this
important hypothesis."
As previously announced, Eyetech and Pfizer plan to conduct a pivotal Phase 2/3
DME clinical trial that will include the diabetic retinopathy score as a
pre-specified secondary endpoint. This trial is expected to begin in the second
half of 2005.
"There is a tremendous unmet medical need for the 5.3 million of people in the
U.S. who suffer from diabetic retinopathy. We are hoping that future trials may
demonstrate that Macugen is effective in treating or preventing the progression
of diabetic retinopathy," said Anthony P. Adamis, M.D., Chief Scientific Officer
of Eyetech. "Eyetech remains focused on diseases affecting the back of the eye
because we believe these represent the largest unmet needs in ophthalmology. Our
clinical development program for Macugen, in partnership with Pfizer, continues
to progress."
FINDINGS IN RETROSPECTIVE SUBGROUP ANALYSIS OF MACUGEN DME PHASE 2 DATA
Researchers conducted a retrospective analysis of 69 patients within the Macugen
0.3 mg and usual care arms who had recognized and gradable diabetic retinopathy
at both baseline and week 36. In these two arms of the trial, patients treated
with Macugen 0.3 mg therapy showed an improvement in the ETDRS diabetic
retinopathy severity scale, a standard for monitoring the progression of
retinopathy. At week 36, 11 of the 39 Macugen 0.3 mg dosed patients (28.2
percent) showed improvement of > or = 1 step versus four of 30 in the sham group
(13.3 percent). In addition, a higher proportion of Macugen patients (five of
39, 12.8 percent) showed an improvement of > 2 steps at week 36 compared to sham
group (one of 30, 3.3 percent).
Another retrospective analysis from these two arms of the trial included 82
patients for whom assessment of retinal ischemia data was available at both
baseline and week 36 (43 patients receiving 0.3 mg Macugen, 39 patients
receiving usual care). In this analysis, 16 percent of Macugen patients had less
capillary loss, compared to five percent of patients receiving usual care.
In another analysis of all patients treated with Macugen, (0.3 mg, 1 mg, 3 mg
doses), 13 were noted to have retinal neovascularization upon their baseline
examination. Of these 13 patients, regression in retinal
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neovascularization was noted at week 36 in eight (62 percent), while no
regression of neovascularization was recognized in sham patients who had
neovascularization at baseline. As well, recurrence of neovascularization
followed discontinuation of Macugen in three of the eight subjects (38%) at week
52.
MORE ABOUT THE PHASE 2 DME STUDY
In a Phase 2, double-masked, sham-controlled study of 172 DME patients, 73
percent of patients receiving 0.3 mg Macugen experienced stable or improved
vision at week 36, compared to 51 percent of patients who received sham
(p=0.023). Among Macugen 0.3 mg patients: 59 percent reported vision gain of at
least one line (5 letters) versus 34 percent of sham (p=0.010); 34 percent
reported vision gain of at least two lines (10 letters) versus 10 percent of
sham (p=0.003); and 18 percent reported vision gain of at least three lines (15
letters) versus seven percent of sham (p=0.12). In addition, 42 percent of
patients receiving Macugen 0.3 mg showed a decrease in mean retinal thickness of
at least 100 microns, compared to 16 percent of sham. As well, at the end of the
study, only half as many patients who received Macugen needed additional laser
therapy compared to those receiving usual care (25% vs. 48%).
ABOUT DIABETIC RETINOPATHY
Diabetic retinopathy is a disease affecting the blood vessels of the retina,
resulting in multiple abnormalities including retinal thickening or edema,
hemorrhages, impeded blood flow (retinal ischemia), excessive leakage of fluid
from blood vessels and, in the final stages, abnormal blood vessel growth. Such
blood vessel growth (proliferative diabetic retinopathy) can lead to hemorrhages
and severe retinal damage. When the blood vessel leakage causes swelling within
the macula, it is referred to as DME.
According to the American Diabetes Association (ADA), there are at least 18
million people diagnosed with diabetes in the United States. After 10 years of
disease duration, 75 percent of diabetics have developed some form of diabetic
retinopathy. Diabetes is the leading cause of blindness in adults 20 to 74 years
of age in the United States, and DME is the leading cause of vision loss for
patients with diabetes. In the United States, there are approximately 500,000
people suffering from DME, with approximately 75,000 new cases each year. There
is a significant unmet medical need for a new therapy for this 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.
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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.
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 and further developing Macugen(R) (pegaptanib sodium
injection) with Pfizer Inc for the treatment of neovascular AMD. Macugen is also
being studied for other indications including diabetic macular edema and retinal
vein occlusion.
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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 strategy, future operations,
future clinical trials, prospects, 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 successful recruitment of
patients for the clinical development of Macugen in DME; successful outcomes in
the further clinical development of Macugen; regulatory approval of Macugen for
DME; continued acceptance of Macugen by the medical community, by patients
receiving therapy and by third party payors for neovascular AMD; supplying
sufficient quantities of Macugen to meet anticipated market demand; our
dependence on third parties to manufacture Macugen; the impact of competitive
products and potentially competitive product candidates; our dependence on our
strategic collaboration with Pfizer; obtaining, maintaining and protecting the
intellectual property incorporated into our product candidates; new information
arising out of clinical trial results; and the success of Macugen's recent
launch for use in neovascular AMD. These and other risks are described in
greater detail in the "Risk Factors" section of our most recent annual report on
Form 10-K filed with the United States Securities and Exchange Commission. 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.
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