Glaukos Corporation got US Food and Drug Administration approval of iDose TR, its intracameral implant of travoprost for glaucoma, on 14 December, but it appears the company’s regulatory work is only beginning because the product label does not authorize reimplantation of the drug-device combination product.
Glaukos Gets Approval For Glaucoma Implant, With A Catch
Label Does Not Authorize Re-Implantation Of iDose TR
Glaukos got US FDA approval for its intracameral implant of travoprost for glaucoma and hopes the product will work for up to three years. It also set a high goal for first-year sales.
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