OPKO Health, Inc. (Amex: OPK) announced that a study published in the peer-reviewed journal
Molecular Vision demonstrates that bevasiranib, its siRNA (small
interfering RNA) agent is distributed throughout the eye, including
extensive uptake into the retina. In two tissue distribution and
pharmacokinetic studies in rabbits, results showed that bevasiranib was
present in the retina and in targeted retinal pigment epithelium (RPE)
cells following intravitreal injection. Bevasiranib is a gene-silencing
agent designed to shut down the production of vascular endothelial growth
factor (VEGF), a primary cause of the new blood vessel growth, or
neovascularization, associated with vision loss in patients with wet
age-related macular degeneration, or wet AMD. The efficacy and safety of
bevasiranib are currently being assessed in the COBALT study, an
international Phase III trial for the treatment of wet AMD.
“Importantly, these data indicate that following intravitreal
injection, bevasiranib distributes to the ocular structures relevant to the
VEGF-induced neovascularization associated with vision loss in wet AMD, and
we believe this animal data provides support for the use of bevasiranib in
our ongoing pivotal Phase III trial for the treatment of wet AMD,” said
Samuel Reich, Executive Vice President of OPKO Ophthalmics. “It is
noteworthy that bevasiranib was distributed to the RPE cells, since we
believe that even a fraction of the tissue-associated bevasiranib entering
the RPE cell is likely to be effective in specifically suppressing VEGF
production.”
“Ocular biodistribution of bevasiranib following a single intravitreal
injection to rabbit eyes,” NS Dejneka, S Wan, OS Bond, DJ Kornbrust, SJ
Reich, Molecular Vision, Volume 14, May 28, 2008
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company. Its lead
investigational drug, the pioneering gene silencing agent bevasiranib, has
entered 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 opko.
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 the potential benefits and effectiveness of
bevasiranib in suppressing the production of VEGF and reducing ocular
neovascularization, our ability to establish OPKO’s leadership position,
our ability to aggressively engage in R&D activities and advance clinical
testing of bevasiranib and our ability to develop a preclinical pipeline of
novel agents for ophthalmic diseases, as well as other non-historical
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the risks that enrollment of patients for the Phase III clinical trial for
bevasiranib, may not be successful, that the Phase III clinical trial
itself may not be completed on a timely basis or at all, that any of our
compounds under development, including bevasiranib, may fail, may not
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OPKO Health, Inc.
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