Eyetech (NASDAQ:EYET)
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Eyetech Announces Approval of Macugen(R) in Canada for The
Treatment of Neovascular (Wet) Age Related Macular Degeneration
-- First treatment that helps preserve vision in all subtypes of neovascular
AMD by targeting an underlying cause of disease --
NEW YORK, May 5 /PRNewswire-FirstCall/ -- Eyetech Pharmaceuticals, Inc.
(NASDAQ:EYET) announced today that Health Canada granted approval (Notice of
Compliance) for Macugen(R) (pegaptanib sodium injection) for the treatment of
subfoveal choroidal neovascularization (CNV) secondary to neovascular age-
related macular degeneration (neovascular AMD). Macugen is the first therapy
indicated in Canada for the treatment of subfoveal neovascular AMD regardless
of lesion subtype or size. Approval of Macugen follows a priority review by
Health Canada. Macugen was approved in the United States on December 17, 2004
and was launched on January 20, 2005. Eyetech and Pfizer Inc co-promote
Macugen in the U.S. Eyetech has granted Pfizer the exclusive rights to
commercialize Macugen in countries outside the U.S., including Canada, pursuant
to a royalty-bearing licensing agreement.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050407/EYETLOGO )
Macugen is the first in a new class of ophthalmic drugs to specifically target
vascular endothelial growth factor (VEGF), a protein that acts as a signal in
triggering the abnormal blood vessel growth and leakage that is the hallmark of
neovascular AMD.
Macugen specifically binds to VEGF 165, a protein that plays a critical role in
angiogenesis (the formation of new blood vessels) and increased permeability
(leakage from blood vessels), two of the primary pathological processes thought
to be responsible for the vision loss associated with neovascular AMD. Thus,
Macugen helps preserve vision by slowing vision loss.
"Preserving vision will make a significant difference to patients with
neovascular AMD since the disease can severely compromise a patient's ability
to function independently," said Wanda Hamilton, Executive Director of AMD
Alliance International. "Neovascular AMD can lead to a rapid loss of central
vision that impairs activities such as reading, driving a car, crossing streets
and other basic tasks. As loss of vision progresses, patients often need help
performing or adapting to basic activities of daily living."
Neovascular AMD is the leading cause of irreversible severe vision loss in
patients older than 60 years of age in developed countries. More than 500,000
people worldwide lose their sight annually from the disease. In Canada, nearly
1.5 million people live with some form of AMD, with more than 100,000
experiencing the active blood vessel growth and blood vessel leakage associated
with neovascular AMD. Each year more than 20,000 new cases of neovascular AMD
are reported in Canada, with the incidence likely to increase significantly
with a growing aging population.
"Macugen is a significant new medicine that has already begun to change the
treatment paradigm for neovascular AMD in the U.S.," said David R. Guyer, M.D.,
Chief Executive Officer of Eyetech. "The decision from Health Canada is an
important step towards making Macugen available to patients in Canada whose
quality of life and independence are threatened by this devastating disease."
Macugen is administered in a 0.3 mg dose once every six weeks by intravitreal
injection. It is expected that Canadian ophthalmologists will start treating
patients with Macugen later this year. Macugen has also been filed for
approval in the European Union, Australia, Switzerland and Brazil.
About Macugen
Macugen is indicated in the United States for the treatment of neovascular
age-related macular degeneration. 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 of the
pathological processes that contribute to the vision loss associated with
neovascular AMD.
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