FDA approves Glaukos’ iDose TR treatment for glaucoma disease

Glaukos Corporation has announced that the US Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for a single administration per eye of iDose TR (travoprost intracameral implant) 75mcg, a prostaglandin analogue which is indicated for the reduction of intraocular pressure (IOP) in patients diagnosed with either ocular hypertension (OHT) or open-angle glaucoma (OAG).

iDose TR is a “first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24.7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time,” according to the company’s press release.

This FDA approval follows results from two prospective, randomised, multicenter, double-masked, phase 3 pivotal trials (GC-010 and GC-012) which were intended to compare the safety and efficacy of a single dose of one of two iDose TR models with different travoprost release rates (fast- or slow-release iDose TR models) to topical timolol ophthalmic solution twice per day, in reducing IOP in patients with OAG and OHT.

Thomas Burns, Glaukos’ chairman and chief executive officer, commented: “The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago. Today’s approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need. We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension. We are grateful to the clinical investigators and study participants in the clinical trials for their instrumental roles in helping us reach this important advancement for glaucoma patient care. At Glaukos, we are relentlessly focused on delivering novel therapies for chronic eye diseases and now iDoseTR has the potential to redefine the standard of care for patients in the US affected by OAG and OHT.”

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