Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.
The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy. It continuously delivers 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods. Glaukos designed iDose TR to improve the standard of care by addressing patient non-compliance issues. The implant also addresses the chronic side effects associated with topical glaucoma medications.
Glaukos Chair and CEO Thomas Burns called the approval “a significant milestone” in a news release. He said the road to approval began with the original idea nearly 15 years ago. The approval “ushers in a new era” of glaucoma therapy, the CEO said.
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