OPKO Health Acquires Company Developing Novel Glaucoma Therapy
-Vidus Ocular's Innovative Aquashunt(TM) Device Offers Potential Advantages-
-Glaucoma Affects 2.4 Million Americans and 60 Million People Worldwide-
MIAMI, May 7 /PRNewswire-FirstCall/ -- OPKO Health, Inc. (Amex: OPK) today announced that it has acquired Vidus Ocular, Inc., a privately held company that is developing Aquashunt(TM), an innovative shunt to treat glaucoma, the second leading cause of blindness in the U.S., in an all-stock transaction. Aquashunt is an implantable physiologic device that is designed to address the shortcomings of current glaucoma treatments. Glaucoma is presently treated with drugs, lasers and surgery, but each has limitations, including efficacy, safety and cost issues.
The patented Aquashunt device was designed by Dr. Bruce Shields, Chairman Emeritus of the Department of Ophthalmology and Visual Sciences at the Yale University School of Medicine. Aquashunt is a simple but elegant approach that uses biocompatible materials and is designed for rapid, simple, minimally traumatic insertion. Aquashunt is intended to reduce intraocular pressure physiologically by allowing excess fluid in the eye to exit naturally. It currently is in preclinical testing and human studies are expected to begin during the fourth quarter of this year.
"Aquashunt is designed to offer a new therapeutic option with significant benefits compared to current therapies," said Dr. Naveed Shams, Chief Medical Officer and Senior Vice President of Research and Development of OPKO. "As a device, it also has the potential for a relatively rapid and straightforward development and regulatory pathway. We believe the acquisition of Vidus Ocular is an excellent strategic fit with our ophthalmics business, providing us with the potential to market an innovative product that addresses a serious disease affecting millions of people."
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.
"We designed Aquashunt with the goal of translating our extensive experience in treating glaucoma into a new type of therapy that would leverage physiologic principles to treat patients more safely, effectively and economically," said Dr. Shields, Chief Scientific and Medical Officer of Vidus Ocular. "Preclinical data on the device are encouraging, and we believe that OPKO is an ideal partner to assume responsibility for the development and commercialization of this potentially important product."
Glaucoma is a significant worldwide health problem affecting patients globally. According to the terms of the agreement, OPKO will also work with Yale University on a number of initiatives to increase access to the Vidus shunt technology in the developing world.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its lead investigational drug, the pioneering gene silencing agent bevasiranib, is being assessed in a pivotal Phase III trial after successfully completing Phase II trials for wet age-related macular degeneration and diabetic macular edema. OPKO is developing a preclinical pipeline of novel agents for ophthalmic diseases, and it markets innovative diagnostic imaging systems that complement the company's therapeutic products. 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 a preclinical pipeline of novel agents for ophthalmic diseases, the effectiveness of the device in reducing intraocular pressure physiologically, the timing of the commencement of human studies for the device, the safety, costs, and effectiveness of the Aquashunt device as compared to other glaucoma treatments, whether the design of the device will prove to permit simple and minimally traumatic insertion, and whether the regulatory pathway will be as rapid and as straightforward as anticipated, 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.
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SOURCE OPKO Health, Inc.
Released May 7, 2008