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FDA panel recommends premarket approval for IOP-lowering micro-bypass stent
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Amid some concern about long-term efficacy, the U.S. Food and Drug Administration's Ophthalmic Devices Panel recommended premarket approval of the Glaukos iStent Trabecular Micro-Bypass Stent July 30.
The stent is indicated for use with adjunctive cataract surgery to reduce IOP in patients with mild to moderate open-angle glaucoma who currently use ocular hypotensive medication.
According to a meeting summary, the panel determined that the device is sufficiently safe and effective in treating open-angle glaucoma, and that its benefits outweigh its risks.
"The panel voiced concerns with the overall effectiveness of the iStent Trabecular Micro-Bypass Stent," the summary said. "Additionally, the panel noted a lack of effectiveness at 24 months and recommended that the indication for use reflect the temporary nature of the device's effectiveness."
Review of the premarket approval application submitted by Glaukos was based on a 2-year, prospective, randomized clinical trial conducted at 27 sites in the U.S. Primary efficacy endpoints were evaluated 12 months after stent implantation.
The meeting summary can be read here.
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