OPKO Health Initiates Clinical Trial of the Aquashunt(TM) to Treat Glaucoma
MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (AMEX:OPK) announced today that it has begun treating patients in a clinical trial of its Aquashunt(TM), a device for the treatment of refractory open angle glaucoma. The study, at two academic departments of ophthalmology, is designed to assess the safety and efficacy of the Aquashunt(TM) and will enroll up to 20 patients with significantly impaired visual acuity.
The Aquashunt(TM) is a novel device designed to lower intraocular pressure by allowing excess fluid in the eye to exit more naturally than occurs with presently available devices.
"We are pleased by the simplicity of the surgical procedure for the device and by the early results in the first human trials," commented Bruce Shields, M.D., Professor of Ophthalmology at Yale University and designer of the Aquashunt(TM). "These early results provide further validation of our optimism for the future of the Aquashunt(TM), and we look forward to completing our clinical trials and bringing this product to market."
Glaucoma occurs when fluid accumulating in the eye raises the intraocular pressure and causes the optic nerve to degenerate, potentially leading to irreversible vision loss. Glaucoma is increasing in prevalence as the population ages, currently affecting an estimated 2.4 million people in the U.S. and about 60 million people worldwide.
It is the leading cause of bilateral, irreversible blindness.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company engaged in the development, marketing, and sales of novel agents and both diagnostic and therapeutic devices for the management of ophthalmic diseases. For more information visit the company's website at www.opko.com.
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding our product development efforts, our ability to develop novel agents and devices for the management of ophthalmic diseases, our ability to complete the Aquashunt clinical trials and bring the product to market, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Source: OPKO Health, Inc.
Released January 22, 2009