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Senior Citizen Health & Medicine
Clinical Trial Uses Eye Drops to Restore Sight in
Elderly with Age-Related Macular Degeneration
Eye drops may replace multiple injection treatment
now used
Aug. 16, 2007 - An 88-year-old man at The Methodist
Hospital in Houston is one of two patients in the world today to receive
an investigational eye drop that may restore sight for those suffering
from neovascular (wet) age-related macular degeneration, a major cause
of central visual loss and one of the leading causes of blindness in
people over 60 in the United States.
Currently, the standard treatment requires multiple
injections into the diseased eye.
Yesterday, the patient received the topical
administration of the drug called TG100801 in a Phase IIa, multi-center
trial sponsored by TargeGen, Inc.
In pre-clinical models, the investigational drug
blocked new blood vessel growth and leakiness, which lead to AMD, by
inhibiting VEGF and other related proteins that are believed to play a
critical role in the formation of new blood vessels.
TG100801 is also designed to reduce inflammation
(including edema), a common symptom of AMD, and other back of the eye
diseases, including diabetic macular edema and diabetic retinopathy. In
as little as a month, investigators may learn if the eye drops were
effective.
“If the eye drops work, it will be much better for
the patient,” said Dr. David Brown, a retinal surgeon at Methodist and
primary investigator at Vitreoretinal Consultants.
“We’re continually looking for more effective
treatments for our many AMD patients. If we can get this effect without
injections, that would be a major breakthrough.”
AMD occurs in two forms: dry and wet. While all
cases begin as the dry form, wet AMD accounts for about 85 percent of
all AMD-related blindness and can result in sudden and severe vision
loss.
The dry form is associated with atrophic cell death
of the central retina or macula.
The wet form is caused by growth of abnormal blood
vessels that leak fluid and blood under the macula causing scar tissue
that destroys the central retina.
In 2006, the FDA approved the injectable drug
Lucentis for wet AMD, based on data from two large Phase III clinical
trials, in which Brown and his colleagues enrolled the most patients
worldwide and published their data in the New England Journal of
Medicine.
Dry AMD, the most common form of the disease,
represents approximately 85 to 90 percent of all AMD cases in the
country. Currently, there is no FDA approved treatment for dry AMD.
Approximately 40 patients will be enrolled in the
TargeGen Phase IIa trial in eight trial centers in the United States.
For more information on the study at Methodist, call (713) 790-3333 or
go to
http://www.methodisthealth.com.
Editor's Notes:
About The Methodist Hospital
The Methodist Hospital in Houston is one of the
nation’s largest private, non-profit general hospitals. Dedicated to
providing the highest level of patient care, Methodist has a 90 year
legacy of medical breakthroughs, such as the world’s first
multiple-organ transplant in the 1960s, gene therapy for prostate
cancer, and the first islet cell transplants in Texas.
Methodist is ranked among the country’s top
centers in 14 specialties in U.S News & World Report’s 2007 America’s
Best Hospitals issue. The hospital ranked in more specialties than any
other hospital in Texas. Methodist is also 9th on FORTUNE’s “100 Best
Companies to Work For” in 2007.
Methodist is primarily affiliated with Weill
Cornell Medical College and New York Presbyterian Hospital, two of the
nation’s leading centers for patient care, medical education and
research. Methodist also is affiliated with the University of Houston.
For more information, call (713) 790-3333 or visit
www.methodisthealth.com.
About TargeGen, Inc.
TargeGen, Inc. is a privately held vascular
biology-focused biopharmaceutical company based in San Diego, CA.
TargeGen is developing novel small molecule therapeutics to treat
certain diseases involving vascular leakage, vascular proliferation,
inflammation, and hematological malignancies by targeting certain
biochemical processes associated with the formation and repair of blood
vessels and vascular permeability (edema).
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