Aquashunt™
Aquashunt™ is a novel glaucoma drainage device (GDD) invented by Dr. Bruce Shields at Yale University. This innovative shunt device is used for the treatment of glaucoma, the second leading cause of blindness in the U.S.
The patented Aquashunt™ device is intended to reduce intraocular pressure physiologically by allowing excess fluid in the eye to exit naturally. In January 2009, we began treating patients in a clinical trial designed to assess the safety and efficacy of the Aquashunt™ device.
About Glaucoma
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.
Bevasiranib and Other siRNAs
Bevasiranib, an siRNA targeting Vascular Endothelial Growth Factor (VEGF) for the treatment of age-related macular degeneration (AMD), is the most advanced siRNA at OPKO and the first siRNA in the industry to enter a Phase III clinical trial.
VEGF plays a key role in the underlying angiogenesis process in wet AMD. On March 6, 2009, OPKO decided to terminate the Phase III clinical trial of bevasiranib based on the recommendation of the Independent Data Monitoring Committee that the bevasiranib clinical trial, as designed, was unlikely to achieve its primary endpoint of reducing vision loss. Alternative ways to develop bevasiranib are being considered, such as new dosing schedules, combining it with marketed products for AMD, and enhancing delivery with novel siRNA delivery vehicles.
OPKO has siRNAs against other molecular targets involved in the pathogenesis of AMD and other diseases. These include:
- VEGF-specific isoforms (e.g. VEGF165b-sparing)
- Hypoxia Inducible Factor-1 alpha (HIF-1alpha)
- Intracellular Adhesion Molecule-1 (ICAM-1)
- Angiopoietin-2 (Ang-2)
- Complement factor, C3
About AMD
AMD is a retinal disease that causes loss of vision, even blindness. There are two forms of AMD known as Wet and Dry AMD. Wet AMD is the result of the formation of new, leaky, poorly organized blood vessels under the retina, in a process known as neovascularization. In the dry form, there is a breakdown or atrophy of the layer of retinal pigment epithelial cells. AMD afflicts approximately 15 million Americans, and many millions more worldwide. About 90% of AMD is the dry form, but it is typically less severe than the wet form. Age is the primary risk factor for AMD, and the number of cases of AMD is expected to increase significantly as the population ages. Currently there is no proven pharmaceutical therapy for Dry AMD. Lucentis™, a VEGF-mediated anti-angiogenesis inhibitor, has become the standard of care for Wet AMD. However, new treatments that are more efficacious are desired.
Doxovir™
In June 2008, OPKO acquired exclusive worldwide rights from Redox Pharmaceuticals to develop and commercialize Doxovir™ for the treatment of viral conjuncitivitis.
Doxovir™ is a cobalt-containing compound which scavenges superoxide radicals and has potent anti-viral and anti-inflammatory properties in preclinical models. In Phase I trials it was shown to be safe and well-tolerated as an eye drop. A Phase II clinical trial to evaluate the safety and efficacy of Doxovir™ in patients with viral conjunctivitis is expected to begin in the second half of 2009.
About Viral Conjunctivitis
Viral conjunctivitis is a common eye infection often caused by adenoviruses, and can be epidemic in certain geographic regions on a seasonal basis. These infections are irritating and uncomfortable during the active course of the illness, but are generally self-limited and rarely affect vision longer term. Treatment is mostly symptomatic with cold compresses and artificial tears, and, in the more severe cases, topical corticosteroids are used. At present, there are no approved antiviral agents for the treatment of these infections and medical care is limited to supportive management of symptoms.