PALM BEACH GARDENS, FL--(Marketwire - January 29, 2010) -
Eyetech Inc. announced today the
results of a preliminary study assessing the investigational use of Macugen
for macular edema secondary to branch retinal vein occlusion (BRVO) that
were published in the January issue of the American Journal of
Ophthalmology (AJO). The uncontrolled, dose-finding study showed that half
of the patients in the study (N=20) gained at least 3 lines of vision by 30
weeks with Macugen injections administered at 6-week intervals, and
patients maintained these improvements for the duration of the 54-week
study. The response was shown to be rapid after the first injection, with a
mean improvement of approximately 2 lines of vision after 1 week.
Investigators also observed a reduction in retinal thickness and macular
volume at both 0.3 mg and 1.0 mg doses of Macugen, suggesting a positive
"This small study provides early and encouraging evidence that Macugen may
be an effective option for the treatment of BRVO," said John Wroblewski,
M.D., lead author of the paper. "While these findings are promising,
randomized and controlled clinical trials are needed to evaluate the
efficacy, optimal treatment interval and duration, and safety of Macugen in
patients with BRVO."
After 54 weeks and a mean number of Macugen injections of 7.2, the mean
best-corrected visual acuity (BCVA) improved 14 letters over baseline, mean
center point thickness decreased 205 µm, and mean macular volume decreased
2.2 mm3. Similar improvements in mean BCVA were seen with the 0.3 mg and 1
mg doses. At week 1, 47% of eyes had gained at least 10 letters and 18% had
gained 15 letters or more. At week 30, 50% of eyes had gained 15 or more
letters. These improvements were sustained at 54 weeks.
One retinal detachment and no cases of endophthalmitis or traumatic
cataract were seen in the study. There was also no evidence of a sustained
effect on intraocular pressure or of an increased risk of systemic adverse
events related to VEGF inhibition detected.
About the Study
The study, entitled "Pegaptanib Sodium for Macular Edema Secondary to
Branch Retinal Vein Occlusion," was a prospective, randomized, dose-finding
non-controlled study conducted at three clinical practices in the United
States. Twenty patients who had a 1 to 6 month history of macular edema
secondary to BRVO were randomized to receive intravitreal injections of
either 0.3 mg Macugen (N=15) or 1 mg Macugen (N=5) at baseline and at weeks
6 and 12, with subsequent injections at 6-week intervals at investigator
discretion until week 48. Principal efficacy outcomes were: change from
baseline to week 54 in BCVA, center point thickness, central subfield
thickness, and macular volume as measured by optical tomography.
About Retinal Vein Occlusion (RVO)
Retinal vein occlusion (RVO) is a blockage in the blood supply from the
retina, causing swelling (macular edema) and hemorrhages which often leads
to sudden blurring or vision loss in all or part of one eye. It is second
only to diabetic retinopathy as a cause of vision loss due to retinal
vascular disease. There are two types of RVO: branch retinal vein occlusion
(BRVO) and central retinal vein occlusion (CRVO). BRVO occurs when one of
the branches of the main vein is blocked and CRVO occurs when the main vein
of the eye is blocked. Most retinal vein occlusions occur after age 50,
although younger patients are sometimes seen with this disorder. The
highest rate of occurrence is in individuals in their 60's and 70's.
Macugen, a selective inhibitor of VEGF-165, is approved 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
Eyetech Inc. markets and sells Macugen in the United States, and Pfizer
Inc. markets and sells Macugen outside of the United States. For full
prescribing information about Macugen, please visit
Important Safety Information
Macugen is contraindicated in patients with ocular or periocular infections
or with known hypersensitivity to pegaptanib sodium or any other excipient
of this product.
Safety or efficacy of Macugen beyond two years has not been demonstrated.
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.
Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema,
have been reported in postmarketing experience following the intravitreal
Serious adverse events related to the injection procedure occurring in less
than 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 Inc.
Eyetech Inc. is a unique, independent 100% employee-owned and operated
biotechnology company dedicated exclusively to the treatment of
sight-threatening diseases of the retina. For more information about
Eyetech, please visit www.eyetech.com.