The FDA-cleared shunt was found to be "safe and effective" when it
was implanted in 24 eyes of 23 patients with severe open angle
glaucoma--the most common form of glaucoma, affecting some three
million Americans.
It is a fact that, 16 of the 24 eyes (66%) had previously failed
the trabeculectomy procedure for treating glaucoma. The remaining
eight (33%) were deemed "high risk for failure" and therefore
contraindicated for a trabeculectomy procedure. Nevertheless, the
Ex-PRESS "significantly reduced" intraocular pressure (IOP) in all
patients, on average by 50%. Increased IOP is a result of glaucoma.
"The search for the perfect glaucoma device has continued for nearly
a century," said the clinical study's lead investigator, Elie Dahan,
MD, Ophth, Department of Ophthalmology, University of the
Witwatersrand, Johannesburg, South Africa.
"This mini shunt procedure is relatively simple and can be performed
in less than half the time of a trabeculectomy. Equally important,
the Ex-PRESS device is biocompatible, and its structure ensures
minimal tissue trauma. In addition, no removal of scleral tissue and
good aqueous flow control (limited by the 50-micron device lumen)
suggest that the Ex-PRESS procedure is less complicated and more
predictable than the gold standard, trabeculectomy."
Glaucoma is a disease usually characterized by an increase in
pressure within the eye. This may, in time, result in damage to the
optic nerve, with loss of peripheral or side vision, and ultimately
blindness. The higher the pressure within the eye, the greater the
chance of damage to the optic nerve. Approximately 10 million
Americans have elevated eye pressure, which places them at risk for
the onset of glaucoma. Eighty thousand Americans are already blind
from the disease. African-Americans have a five-fold greater risk of
developing glaucoma.
Optonol is a privately held medical technology company founded by a
group of experienced clinicians, engineers and entrepreneurs. The
company's initial area of focus is the development of innovative
devices for ophthalmologic applications. Its first product in this
field is the patented Ex-PRESS mini glaucoma shunt , a
microscopic-sized implant that significantly reduces intraocular
pressure. Optonol's U.S. headquarters are located in Kansas City,
Missouri. The company has facilities in Neve-Ilan, Israel, and has
operations in Zug, Switzerland.
Israeli start-up Optonol announced that a "Journal of Glaucoma" study
has called its Ex-PRESS mini glaucoma shunt "simpler and more
predictable" than the standard procedure known as trabeculectomy.