OPKO launches new imaging device and kicks off trial

February 4, 2009

OPKO Health, Inc has received FDA marketing clearance on an imaging device and launched clinical trials of a new glaucoma shunt, the company has announced.

OPKO Health, Inc has received FDA marketing clearance on an imaging device and launched clinical trials of a new glaucoma shunt, the company has announced.

The Spectral OCT SLO Combination Imaging System, which is already available in Europe, is now also available for marketing in the US, following receipt of FDA 510(k) clearance. The diagnostic device, for non-contact, non-invasive tomographic and confocal imaging, produces high resolution images of the inner retinal choroid with vitreous detail. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including the retina, macula, retina nerve fibre layer and optic disc; altering the focal position allows the device to image the cornea, sclera and conjunctiva.

OPKO has also initiated clinical trials of the Aquashunt, a shunt to treat refractory open-angle glaucoma by providing an exit for excess fluid in the eye thereby reducing intraocular pressure (IOP). The Aquashunt has been implanted in the first human patients of its multicentre clinical trials, which will enrol up to 20 patients with significantly impaired visual acuity. The trials are designed to assess safety and efficacy.