Glaukos Awaits iStent Approval, And New Randomized Trial Requirement
This article was originally published in The Gray Sheet
Glaukos will likely have to conduct a new, five-year prospective randomized post-market study for its iStent glaucoma device if FDA approves the product's PMA
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Recent market launches and clearances include Glaukos’ iStent for glaucoma, Beckman Coulter’s Prostate Health Index blood test for prostate cancer and Siemens’ Sysmex CA-600 Systems for lab hemostasis testing.
An FDA advisory panel July 30 offered strong support to an implantable glaucoma treatment up for PMA approval. The Ophthalmic Devices Panel voted 7-1 that the benefits of Glaukos Corp.'s iStent trabecular micro-bypass stent outweigh the risks. The advisors voted by the same margin that they had reasonable assurance the device would be safe, and 6-2 that there was a reasonable assurance of effectiveness. If approved, iStent would be indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure in patients with mild to moderate open-angle glaucoma who are being treated with ocular hypotensive medication. It would be the first shunt-type device indicated for non-refractory glaucoma, according to FDA. The agency and Glaukos agreed to long-term post-approval studies prior to the meeting, and the panel also recommended that a device registry be established