Opko announces clearance for imaging system, trial for glaucoma device

MIAMI — The Spectral OCT SLO Combination Imaging System, a diagnostic tool used for high-resolution imaging of posterior ocular structures, received 510(k) clearance from the U.S. Food and Drug Administration to begin marketing in the United States, Opko Health said in a press release.

The system provides a non-contact, non-invasive means for tomographic and confocal monitoring of ophthalmic disease affecting the retina, macula, retina nerve fiber layer and optic disc. By changing the focal position, the system can image the cornea, sclera and conjunctiva as well.

Opko also announced it has begun treating patients in a clinical trial of the Aquashunt, a device used to lower IOP in patients with refractory open-angle glaucoma. Twenty patients with significantly impaired visual acuity will be enrolled in the trial, which will evaluate safety and efficacy of the device.

The device allows excess fluid in the eye to exit more naturally than occurs with available devices, the company said in a press release.