IOP-LOWERING DEVICE WITHOUT BLEB

The FDA has granted an Investigational Device Exemption (IDE) approval to SOLX, Inc. to begin studies of the DeepLight Gold Micro-Shunt (GMS) implant for glaucoma. The GMS is a 24-karat gold, ultra-thin, flat plate designed for implantation through a single micro-incision. It contains micro-tubular channels that bridge the anterior chamber and suprachoroidal space, maximizing uveoscleral outflow to reduce IOP. The GMS rests permanently in the suprachoroidal space and cannot be felt by the patient. It is biocompatible and physically inert, and it has been shown to eliminate the formation of scar tissue. Multicenter studies of 70 eyes with up to two years follow-up in Spain and Israel demonstrated excellent clinical results. The randomized, multicenter study will evaluate safety and efficacy of the GMS for lowering intraocular pressure (IOP) in patients with primary open-angle glaucoma. who have failed maximum medical therapy and at least one surgical intervention.