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Solx receives IDE for trial of gold glaucoma shunt
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CHICAGO — Solx Inc. announced on the last day of the American Academy of Ophthalmology meeting that it had received approval from the Food and Drug Administration to begin U.S. clinical investigation of its DeepLight Gold Micro-Shunt implant for treatment of glaucoma. The randomized, multicenter study will evaluate the safety and efficacy of the device for lowering IOP in patients with primary open-angle glaucoma, according to a press release from Solx.
Multicenter trials of the device in Spain and Israel with up to 2 years of follow-up in 70 eyes have shown “excellent clinical results,” according to the press release.
The IDE approval follows CE Mark approval from European Union regulators for the device, which was received earlier the same week, according to the company.
At a press briefing held during the meeting, Robert Kershner, MD, described how the Gold Micro-Shunt works as part of the DeepLight Glaucoma Treatment System. The 0.5-mm wide shunt is implanted in the suprachoroidal space, Dr. Kershner said, with one end in the anterior chamber to facilitate aqueous outflow. If more outflow is desired, the 790-nm wavelength DeepLight TiSa laser can be used to open more channels in the implant.
Alternatively, the laser by itself can be used for trabeculoplasty procedures; its wavelength allows deeper tissue penetration than other lasers used in glaucoma procedures without causing thermal damage to the trabecular meshwork, according to Solx.