PRNewswire
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.
Contacts: Media:
Corporate: GendeLLindheim BioCom Partners
Steven D. Rubin Barbara Lindheim
305 575-6015 212 918-4650