Longevity, Safety and Efficacy of the Ex-PRESS Mini Glaucoma Shunt in Reducing Intraocular Pressure in Glaucoma Patients, without Use of Drugs, to Be Reported at the 5th International Glaucoma Symposium.

KANSAS CITY, Mo. -- Optonol:

--Four-year follow-up data after implantation of miniature-sized Ex-PRESS(TM) Mini Glaucoma Shunt shows the shunt was "safe and effective" in reducing intraocular pressure, the primary risk factor for glaucoma, without the use of antiglaucoma medications "in the great majority" of patients studied

New clinical data about the Ex-PRESS(TM) Mini Glaucoma Shunt will be presented at the 5th annual "International Glaucoma Symposium" (IGS) that starts tomorrow in Cape Town, South Africa. IGS is the world's largest scientific meeting devoted to glaucoma. Several studies about Ex-PRESS(TM) from leading researchers across the globe will be presented during this international symposium.

In one study, the FDA-cleared Ex-PRESS(TM) was found to be "safe and effective" when it was implanted in 58 eyes of 44 "high risk for failure" patients with severe open angle glaucoma (OAG)--the most common form of glaucoma, affecting some three million Americans.

Of note, 23 patients (52 percent) had previously failed trabeculectomy, the "gold standard" surgical procedure for treating glaucoma. The remaining 21 patients (48 percent) were deemed "high risk for failure" and therefore were not fit for a trabeculectomy procedure. Nevertheless, as a result of the Ex-PRESS(TM) Mini Glaucoma Shunt implantation, the abnormally high intraocular pressure ("IOP", the primary risk factor for glaucoma) was "significantly reduced" in all patients, on average by 50 percent throughout the four-year-long study. Additionally, reduction of IOP occurred without the use of antiglaucoma medications in "the great majority of the OAG patients."

"These data are impressive," said the clinical study's lead investigator, Elie Dahan, MD, MMed Ophth, Department of Ophthalmology, University of the Witwatersrand, Johannesburg, South Africa. "This study suggests that the Ex-PRESS device is not only effective at reducing IOP in glaucoma patients, but that the results are long-lasting--despite the fact these patients were at high risk for failure. Equally important, most of these patients were able to maintain their reduced IOP in the lower 'teens without using antiglaucoma medications."

Glaucoma, also known as "high eye pressure", is a serious disease characterized by damage to the optic nerve, with subsequent visual loss--initially peripheral, but potentially blinding. Approximately 10 million Americans have elevated eye pressure (intraocular pressure), which places them at risk for the onset of glaucoma. Eighty thousand Americans are already blind from the disease. African-Americans have a three-fold greater risk of developing glaucoma.

Measurement of intraocular pressure is an important part of any eye exam. The IOP is determined by a balance of production and drainage of the eye's aqueous humor (the clear fluid inside the eye). The aqueous humor passes from the anterior chamber through the trabecular meshwork (the drainage system "filter") into Schlemm's canal that is connected to the venous system. When the trabecular meshwork (the filter) is blocked, the IOP is elevated and can cause pressure within the eye to increase and damage the optic nerve by reducing its blood supply. The Ex-PRESS(TM) Mini Glaucoma Shunt bypasses the blocked trabecular meshwork, and transports the aqueous humor from the anterior chamber into the intrascleral and subconjunctival spaces (external coatings of the eye), where blood vessels absorb it.

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(TM) Mini Glaucoma Shunt, a microscopic-sized implant. The primary innovation of the Ex-PRESS(TM) Mini Glaucoma Shunt is its small-diameter fluid transport mechanism that allows effective and safe drainage that mimics natural aqueous humor flow. Optonol's U.S. headquarters are located in Kansas City, Missouri. The Company is headquartered in Neve-Ilan, Israel, and has operations in Zug, Switzerland.